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idK181324_s6000_e8000 | K181324.txt | predicate device name | FilmArray Respiratory Panel 2 plus (RP2plus) | results. Table 3: Interpretation of Controls Field on the FilmArray Pneumonia Panel plus Test Report Control Result Explanation Action Passed The run was successfully completed AND Both pouch controls were successful. None Report the results provided on the test report. Failed The run was completed BUT At least one of... |
idK181324_s92000_e94000 | K181324.txt | proposed labeling | The labeling is sufficient and satisfies the requirements of 21 CFR parts 801 and 809 as well as the Special Controls for this type of device. | ... |
idK190219_s0_e2000 | K190219.txt | purpose for submission | Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K190219 B. Purpose for Submission: Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid C. Measurand: Varizella zoster virus DNA D. Type of Test: Realtime Polymerase Chain Re... |
idK190219_s0_e2000 | K190219.txt | measurand | Varizella zoster virus DNA | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K190219 B. Purpose for Submission: Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid C. Measurand: Varizella zoster virus DNA D. Type of Test: Realtime Polymerase Chain Re... |
idK190219_s0_e2000 | K190219.txt | type of test | Realtime Polymerase Chain Reaction | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K190219 B. Purpose for Submission: Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid C. Measurand: Varizella zoster virus DNA D. Type of Test: Realtime Polymerase Chai... |
idK190219_s0_e2000 | K190219.txt | predicate device name | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray and FilmArray 2.0 systems | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K190219 B. Purpose for Submission: Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid C. Measurand: Varizella zoster virus DNA D. Type of Test: Realtime Polymerase Chain Re... |
idK190219_s0_e2000 | K190219.txt | applicant | DiaSorin | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K190219 B. Purpose for Submission: Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid C. Measurand: Varizella zoster virus DNA D. Type of Test: Realtime Polymerase Cha... |
idK190219_s0_e2000 | K190219.txt | proprietary and established names | Simplexa VZV Direct, Simplexa VZV Positive Control Pack | IAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K190219 B. Purpose for Submission: Clearance of device to detect and identify Varizella Zoster Virus DNA in cerebrospinal fluid C. Measurand: Varizella zoster virus DNA D. Type of Test: Realtime Polymerase Chain Reactio... |
idK190219_s12000_e14000 | K190219.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | ... |
idK190219_s12000_e14000 | K190219.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK190219_s12000_e14000 | K190219.txt | applicant | DiaSorin | ... |
idK150526_s0_e2000 | K150526.txt | purpose for submission | New Device | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory Infor... |
idK150526_s0_e2000 | K150526.txt | measurand | IgG4 subclass Antibody | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory Infor... |
idK150526_s0_e2000 | K150526.txt | type of test | Quantitative, turbidimetric | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory Inf... |
idK150526_s0_e2000 | K150526.txt | classification | Class II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory... |
idK150526_s0_e2000 | K150526.txt | product code | CFN - Method, Nephelometric, Immunoglobulins (G, A, M) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory... |
idK150526_s0_e2000 | K150526.txt | panel | Immunology (82) | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulator... |
idK150526_s0_e2000 | K150526.txt | predicate device name | Binding Site Human IgG and IgG subclass (IgG1, IgG2, IgG3, IgG4) liquid reagent kits for use on the SPAplus | ANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory Infor... |
idK150526_s0_e2000 | K150526.txt | applicant | The Binding Site Group, Ltd. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory... |
idK150526_s0_e2000 | K150526.txt | proprietary and established names | Optilite® IgG4 Kit | EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory Information... |
idK150526_s0_e2000 | K150526.txt | regulation section | 21 CFR §866.5510 - Immunoglobulins A, G, M, D, E Immunological Test System | STANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM 1 A. 510(k) Number: k150526 B. Purpose for Submission: New Device C. Measurand: IgG4 subclass Antibody D. Type of Test: Quantitative, turbidimetric E. Applicant: The Binding Site Group, Ltd. F. Proprietary and Established Names: Optilite® IgG4 Kit G. Regulatory Inf... |
idK150526_s2000_e4000 | K150526.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK150526_s2000_e4000 | K150526.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK161217_s0_e2000 | K161217.txt | purpose for submission | To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK 2 AS... |
idK161217_s0_e2000 | K161217.txt | type of test | Automated quantitative or qualitative antimicrobial susceptibility test for Ceftriaxone | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK ... |
idK161217_s0_e2000 | K161217.txt | classification | Class II | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK... |
idK161217_s0_e2000 | K161217.txt | panel | 83 Microbiology | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITE... |
idK161217_s0_e2000 | K161217.txt | intended use | The VITEK®2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK®2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., S. ... | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK ... |
idK161217_s0_e2000 | K161217.txt | predicate device name | VITEK®2 AST-GN Doxycycline | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK 2 AS... |
idK161217_s0_e2000 | K161217.txt | applicant | bioMérieux, Inc. | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK... |
idK161217_s0_e2000 | K161217.txt | proprietary and established names | VITEK®2 Gram Negative Ceftriaxone (≤ 0.25 - ≥64 µg/mL) | IAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK 2 AST-Gra... |
idK161217_s0_e2000 | K161217.txt | regulation section | 21 CFR 866.1645 Fully Automated Short-Term Incubation Cycle Antimicrobial | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K161217 B. Purpose for Submission: To obtain a substantial equivalence determination for Ceftriaxone for testing of gram negative bacilli on the VITEK®2 and VITEK®2 Compact Antimicrobial Susceptibility Test (AST) Systems. C. Measurand: The VITEK ... |
idK161217_s4000_e6000 | K161217.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK161217_s4000_e6000 | K161217.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK163517_s0_e2000 | K163517.txt | purpose for submission | To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates) and Enterococcus faecalis (vancomycin-susceptible isolates only). | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus a... |
idK163517_s0_e2000 | K163517.txt | measurand | Telavancin 0.016 – 256 µg/mL | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus a... |
idK163517_s0_e2000 | K163517.txt | type of test | Quantitative AST growth based detection | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus... |
idK163517_s0_e2000 | K163517.txt | classification | Class II | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphyloco... |
idK163517_s0_e2000 | K163517.txt | product code | JWY – Manual Antimicrobial Test Systems | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphyloco... |
idK163517_s0_e2000 | K163517.txt | panel | 83 – Microbiology | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphyloc... |
idK163517_s0_e2000 | K163517.txt | intended use | The Liofilchem MIC Test Strip (MTS) is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of non-fastidious Gram negative and Gram positive aerobic bacteria (for example, Enterobacteriaceae, Pseudomonas, Enterococcus and Staphylococcus species) and fastidious bacteria (for exa... | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus... |
idK163517_s0_e2000 | K163517.txt | predicate device name | Liofilchem MIC Test Strip (MTS) – Vancomycin 0.016 – 256 μg/mL | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus a... |
idK163517_s0_e2000 | K163517.txt | applicant | Liofilchem® s.r.l. | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphyloco... |
idK163517_s0_e2000 | K163517.txt | proprietary and established names | Liofilchem MIC Test Strip (MTS), Telavancin 0.016 – 256 μg/mL | EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus aureus ... |
idK163517_s0_e2000 | K163517.txt | regulation section | 866.1640 Antimicrobial Susceptibility Test Powder | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K163517 B. Purpose for Submission: To obtain a substantial equivalence determination for the Liofilchem MIC Test Strip (MTS) containing Telavancin in concentrations of 0.016 – 256 µg/mL for susceptibility testing of Staphylococcus... |
idK163517_s2000_e4000 | K163517.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK163517_s2000_e4000 | K163517.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK182922_s0_e2000 | K182922.txt | purpose for submission | To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms ... |
idK182922_s0_e2000 | K182922.txt | measurand | Omadacycline 0.002-32 μg/mL | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms ... |
idK182922_s0_e2000 | K182922.txt | type of test | Quantitative Antimicrobial Susceptibility Test growth-based detection | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms... |
idK182922_s0_e2000 | K182922.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organism... |
idK182922_s0_e2000 | K182922.txt | product code | JWY - Manual Antimicrobial Susceptibility Test Systems | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organism... |
idK182922_s0_e2000 | K182922.txt | panel | 83 – Microbiology | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organis... |
idK182922_s0_e2000 | K182922.txt | predicate device name | Liofilchem MTS, vancomycin | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms ... |
idK182922_s0_e2000 | K182922.txt | applicant | Liofilchem s.r.l. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organism... |
idK182922_s0_e2000 | K182922.txt | proprietary and established names | MTS Omadacycline 0.002-32 μg/mL | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms C. Mea... |
idK182922_s0_e2000 | K182922.txt | regulation section | 866.1640 Antimicrobial Susceptibility Test Powder | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K182922 B. Purpose for Submission: To obtain a substantial equivalence determination for Omadacycline (OMC) at concentrations of 0.002-32 µg/mL for susceptibility testing of non-fastidious Gram-negative and non-fastidious Gram-positive organisms... |
idK182922_s4000_e6000 | K182922.txt | proposed labeling | The labeling supports the finding of substantial equivalence for this device. | obacteriaceae (all) Clinical 496 494 99.6 488 486 99.6 478 96.4 16 18 0 0 Challenge 82 82 100 41 41 100 71 86.6 49 11 0 0 Combined 578 576 99.7 529 527 99.6 549 95.0 65 29 0 0 10
EA – Essential agr... |
idK182922_s4000_e6000 | K182922.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | points Enterobacteriaceae (all) Clinical 496 494 99.6 488 486 99.6 478 96.4 16 18 0 0 Challenge 82 82 100 41 41 100 71 86.6 49 11 0 0 Combined 578 576 99.7 529 527 99.6 549 95.0 65 29 0 0 10
EA – E... |
idK163260_s0_e2000 | K163260.txt | purpose for submission | To obtain a substantial equivalence determination for the SeptiCyte LAB | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Rev... |
idK163260_s0_e2000 | K163260.txt | measurand | LAMP1, CEACAM4, PLA2G7, PLAC8 | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Rev... |
idK163260_s0_e2000 | K163260.txt | type of test | Reverse transcription + quantitative PCR (RT-qPCR) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Re... |
idK163260_s0_e2000 | K163260.txt | classification | Class II | 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test... |
idK163260_s0_e2000 | K163260.txt | product code | PRE | 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test... |
idK163260_s0_e2000 | K163260.txt | panel | 83: Microbiology | 30 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of T... |
idK163260_s0_e2000 | K163260.txt | indications for use | Same as Intended Use. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Rev... |
idK163260_s0_e2000 | K163260.txt | predicate device name | B·R·A·H·M·S PCT Sensitive KRYPTOR | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Rev... |
idK163260_s0_e2000 | K163260.txt | 510k number | K163260 | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Re... |
idK163260_s0_e2000 | K163260.txt | applicant | Immunexpress, Inc. | 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test... |
idK163260_s0_e2000 | K163260.txt | proprietary and established names | SeptiCyte LAB | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Rever... |
idK163260_s0_e2000 | K163260.txt | regulation section | 21 CFR 866.3215; Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION A. 510(k) Number: K163260 B. Purpose for Submission: To obtain a substantial equivalence determination for the SeptiCyte LAB C. Measurand: Four mRNA transcript immune biomarkers: LAMP1, CEACAM4, PLA2G7, PLAC8 D. Type of Test: Re... |
idK163260_s16000_e18000 | K163260.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK163260_s16000_e18000 | K163260.txt | conclusion | 1. The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK173817_s0_e2000 | K173817.txt | purpose for submission | To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility testing of select Gram-negative bacilli | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility test... |
idK173817_s0_e2000 | K173817.txt | measurand | Ceftazidime/avibactam 0.016/4 – 256/4 µg/mL | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility test... |
idK173817_s0_e2000 | K173817.txt | type of test | Quantitative Antimicrobial Susceptibility Test growth based detection | 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility t... |
idK173817_s0_e2000 | K173817.txt | classification | Class II |
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility ... |
idK173817_s0_e2000 | K173817.txt | product code | JWY – Manual Antimicrobial Test Systems |
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility ... |
idK173817_s0_e2000 | K173817.txt | panel | Microbiology (83) | 11
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibili... |
idK173817_s0_e2000 | K173817.txt | indications for use | Same as Intended Use | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility test... |
idK173817_s0_e2000 | K173817.txt | predicate device name | Liofilchem MTS, Vancomycin | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility test... |
idK173817_s0_e2000 | K173817.txt | applicant | Liofilchem s.r.l. |
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility ... |
idK173817_s0_e2000 | K173817.txt | proprietary and established names | Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 – 256/4 µg/mL | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility testin... |
idK173817_s0_e2000 | K173817.txt | regulation section | 21 CFR 866.1640 Antimicrobial Susceptibility Test Powder | 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K173817 B. Purpose for Submission: To obtain a substantial equivalence determination of the Liofilchem MIC Test Strip (MTS) containing Ceftazidime/avibactam at concentrations of 0.016/4 – 256/4 µg/mL for susceptibility t... |
idK173817_s4000_e6000 | K173817.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. | ... |
idK173817_s4000_e6000 | K173817.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK172745_s0_e2000 | K172745.txt | purpose for submission | New device | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names:... |
idK172745_s0_e2000 | K172745.txt | measurand | IgG Anti-Nuclear Antibodies (ANA) | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names:... |
idK172745_s0_e2000 | K172745.txt | type of test | Qualitative or semi-quantitative, indirect immunofluorescence | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names... |
idK172745_s0_e2000 | K172745.txt | classification | Class II | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Name... |
idK172745_s0_e2000 | K172745.txt | product code | DHN ‒ Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Name... |
idK172745_s0_e2000 | K172745.txt | panel | Immunology (82) | (k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Nam... |
idK172745_s0_e2000 | K172745.txt | intended use | The ImmuGlo HEp-2 Elite IFA is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of anti-nuclear antibodies (ANA) of the IgG isotype in human serum utilizing standard HEp-2 cells and engineered HEp-2 cells as a substrate. The ImmuGlo HEp-2 Elite IFA is intended for use as a... | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names... |
idK172745_s0_e2000 | K172745.txt | predicate device name | ImmuGlo ANTINUCLEAR ANTIBODY (ANA) TEST (HEP-2) CELLS | SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names:... |
idK172745_s0_e2000 | K172745.txt | applicant | IMMCO Diagnostics, Inc. | k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Name... |
idK172745_s0_e2000 | K172745.txt | proprietary and established names | ImmuGlo HEp-2 Elite IFA | ANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names: ImmuG... |
idK172745_s0_e2000 | K172745.txt | regulation section | 21 CFR §866.5100 ‒ Antinuclear antibody immunological test system | ) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K172745 B. Purpose for Submission: New device C. Measurand: IgG Anti-Nuclear Antibodies (ANA) D. Type of Test: Qualitative or semi-quantitative, indirect immunofluorescence E.Applicant: IMMCO Diagnostics, Inc. F.Proprietary and Established Names... |
idK172745_s8000_e10000 | K172745.txt | proposed labeling | The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable. | ... |
idK172745_s8000_e10000 | K172745.txt | conclusion | The submitted information in this premarket notification is complete and supports a substantial equivalence decision. | ... |
idK160082_s0_e2000 | K160082.txt | purpose for submission | To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory culture of bacteria and yeast. | STANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: K160082 B. Purpose for Submission: To make a substantial equivalence determination for the Puritan® Opti-Tranz™ Cary-Blair Collection and Transport System for the collection, transport and storage of fecal specimens for laboratory... |
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