FDA Review Panel · MI

FDA 510(k) Microbiology Devices

FDA 510(k) Microbiology Devices - Regulatory Overview

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

7048
Total
6986
Cleared
159d
Avg (2y)
1976
Since
1404 Microbiology devices
426–450 of 1404
Cleared Oct 20, 2021
InTray GC
K210511 · Biomed Diagnostics Incorporated
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 239d
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 Oct 18, 2021
BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit
K201017 · Geneohm Sciences Canada, Inc. (Bd Life Sciences)
PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 549d
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288 · Opgen, Inc.
PMY · System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony · 871d
Cleared Sep 22, 2021
FilmArray Pneumonia Panel
K212727 · Biofire Diagnostics, LLC
QDP · Respiratory Panel · 26d
Cleared Sep 20, 2021
Disposable Sampler Inactivated Transport Media, Nest ITM
K210440 · Wuxi Nest Biotechnology Co., Ltd.
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 220d
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 Sep 01, 2021
MeMed BV
K210254 · MeMed Diagnostics, Ltd.
QPS · Immunoassay For Host Biomarkers Of Infection · 215d
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
Cleared Aug 26, 2021
Visby Medical Sexual Health
K200748 · Visby Medical
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 521d
Cleared Aug 11, 2021
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit
K212204 · Cd Diagnostics, Inc.
QGN · Lateral Flow Immunochromatography Assay For Host Infection Biomarkers · 27d
Cleared Jul 30, 2021
Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30
K203700 · Oxoid Limited (Part of Thermo Fisher Scientific)
JTN · Susceptibility Test Discs, Antimicrobial · 224d
Cleared Jul 23, 2021
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL)
K202612 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 317d
Cleared Jul 20, 2021
Elecsys Syphilis
K211302 · Roche Diagnostics
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 82d
Cleared Jul 09, 2021
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
K201675 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 385d
Cleared Jul 08, 2021
SensiTox C. difficile Toxin Test
K193490 · First Light Diagnostics, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 569d
Cleared Jun 24, 2021
BioFire RP2.1/RP2.1plus Control Panel M441
K202196 · Maine Molecular Quality Controls, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 323d
Cleared Jun 14, 2021
VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)
K211136 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 59d
Cleared May 18, 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · Beckman Coulter, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 266d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit
K203292 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit
K203295 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d
Cleared Mar 22, 2021
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
K203296 · Gold Standard Diagnostics
LSR · Reagent, Borrelia Serological Reagent · 133d

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All categories 1404 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 167 JWY Manual Antimicrobial Susceptibility Test Systems 122 JTN Susceptibility Test Discs, Antimicrobial 71 QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents 31 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 30 LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems 30 JSJ Culture Media, Selective And Non-differential 29 JSM Culture Media, Non-propagating Transport 27 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 26 LSR Reagent, Borrelia Serological Reagent 25 PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System 25 QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections 23 MDB System, Blood Culturing 23 JSH Culture Media, Non-selective And Differential 21 LJC Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) 21