FDA Review Panel · MI

FDA 510(k) Microbiology Devices

About Microbiology Devices

FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.

Key device types:

  • Blood culture systems - automated incubation and detection platforms
  • Microbial identification - MALDI-TOF, biochemical and molecular ID systems
  • Antimicrobial susceptibility testing - MIC determination and breakpoint analysis
  • Rapid infectious disease tests - influenza, strep, RSV, COVID-19 antigen and molecular tests
  • Molecular diagnostics - PCR panels for respiratory, GI and STI pathogens

7038
Total
6976
Cleared
102d
Avg days
1976
Since
363 Microbiology devices
326–350 of 363
Cleared Jun 10, 2022
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
K221658 · Centers For Disease Control and Prevention
PBK · Non-variola Orthopoxvirus Real-time Pcr Primer And Probe Set · 2d
Cleared Jun 07, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K221160 · Cepheid
PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 47d
Cleared Jun 03, 2022
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
K213931 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 169d
Cleared Jun 03, 2022
Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris
K220321 · Hologic, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 120d
Cleared May 19, 2022
ARCHITECT Toxo IgG
K210596 · Abbott Laboratories
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 444d
Cleared May 10, 2022
BD CTGCTV2
K210585 · Becton, Dickinson and Company
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 438d
Cleared May 09, 2022
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · Cepheid
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 535d
Not Cleared Apr 29, 2022
BioFire Joint Infection (JI) Panel
DEN200066 · Biofire Diagnostics, LLC
QSN · Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System · 549d
Cleared Apr 14, 2022
VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)
K214023 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 113d
Cleared Mar 16, 2022
Healgen Strep A Rapid Test Strip (Throat Swab)
K212623 · Healgen Scientific, LLC
GTY · Antigens, All Groups, Streptococcus Spp. · 210d
Cleared Mar 15, 2022
VITEK MS PRIME
K212461 · bioMerieux, Inc.
QBN · Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 221d
Cleared Feb 25, 2022
VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
K213241 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 148d
Cleared Feb 09, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K212213 · Cepheid
PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 209d
Cleared Dec 23, 2021
Curian Campy
K210976 · Meridian Bioscience, Inc.
LQP · Campylobacter Spp. · 266d
Cleared Dec 20, 2021
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
K203741 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 363d
Cleared Dec 15, 2021
Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL
K211539 · Thermo Fisher Scientific
NGZ · Susceptibility Test Plate, Antifungal · 211d
Cleared Nov 23, 2021
Sofia 2 Campylobacter FIA
K211342 · Quidel Corporation
LQP · Campylobacter Spp. · 204d
Cleared Nov 03, 2021
BD Kiestra IdentifA
K191964 · Becton, Dickinson and Company
QQV · Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry · 834d
Cleared Oct 28, 2021
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
K210287 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 268d
Cleared Oct 20, 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 141d
Cleared Oct 20, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K212427 · Roche Molecular Systems, Inc.
OZN · C. Difficile Toxin Gene Amplification Assay · 77d
Cleared Sep 22, 2021
FilmArray Pneumonia Panel
K212727 · Biofire Diagnostics, LLC
QDP · Respiratory Panel · 26d
Cleared Sep 14, 2021
VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)
K202396 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 389d
Cleared Sep 09, 2021
cobas Cdiff nucleic acid test for use on the cobas Liat System
K210385 · Roche Molecular Systems, Inc.
OZN · C. Difficile Toxin Gene Amplification Assay · 212d
Cleared Aug 30, 2021
VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)
K211630 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 95d

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All categories 363 JWY Manual Antimicrobial Susceptibility Test Systems 32 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 29 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 27 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 15 JSM Culture Media, Non-propagating Transport 13 JTN Susceptibility Test Discs, Antimicrobial 13 QYT Over-the-counter Covid-19 Antigen Test 13 SCA Multi-analyte Respiratory Virus Antigen Detection Test 11 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 10 QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings 8 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 8 QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test 8 NGZ Susceptibility Test Plate, Antifungal 7 SAN Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples 6 PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System 6