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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
376–400 of 7095
Cleared Mar 16, 2023
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
K230404 · Biofire Diagnostics, LLC
PCH · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System · 29d
Cleared Mar 10, 2023
Lyra RSV+hMPV Assay
K230349 · Quidel Corporation
OEM · Human Metapneumovirus (hmpv) Rna Assay System · 29d
Cleared Mar 10, 2023
Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL
K221198 · Thermo Fisher Scientific
NGZ · Susceptibility Test Plate, Antifungal · 318d
Cleared Mar 09, 2023
VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin
K222430 · Biomerieux Sa, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 210d
Not Cleared Mar 08, 2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
DEN220039 · Quidel Corporation
QVF · Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings · 265d
Cleared Mar 07, 2023
Visby Medical Sexual Health Test
K220407 · Visby Medical
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 386d
Cleared Mar 06, 2023
BD Vaginal Panel
K223653 · Becton, Dickinson and Company
PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 90d
Cleared Mar 03, 2023
Lyra Influenza A+B Assay
K230236 · Quidel Corporation
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 32d
Cleared Mar 03, 2023
Alinity m STI Assay
K222379 · Abbott Molecular, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 210d
Cleared Feb 17, 2023
Spectrum Saliva Collection Device
K223497 · Spectrum Solutions, LLC
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 88d
Cleared Feb 16, 2023
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)
K223478 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 90d
Cleared Feb 09, 2023
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
K222073 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 210d
Cleared Feb 03, 2023
VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)
K223481 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 77d
Cleared Feb 03, 2023
SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control
K221253 · Maine Molecular Quality Controls, Inc.
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 277d
Cleared Feb 03, 2023
BIOFIRE SPOTFIRE Respiratory (R) Panel
K213954 · Biofire Diagnostics
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 413d
Not Cleared Feb 03, 2023
Active Anthrax DetectTM Plus Rapid Test
DEN220044 · InBios International, Inc.
QUU · Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples · 210d
Cleared Jan 27, 2023
BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
K223016 · Bd
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 120d
Cleared Jan 27, 2023
VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin
K220803 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 315d
Cleared Jan 26, 2023
Revogene
K222779 · Meridian Bioscience, Inc.
OOI · Real Time Nucleic Acid Amplification System · 134d
Cleared Jan 20, 2023
The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml
K221899 · Thermo Fisher Scientific
NGZ · Susceptibility Test Plate, Antifungal · 204d
Cleared Jan 19, 2023
Biosci™ Inactivated Transport Medium, Biosci™ ITM
K220059 · Shenzhen Dakewe Bio-Engineering Co., Ltd.
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 374d
Cleared Jan 18, 2023
Selux AST System
K211759 · Selux Diagnostics, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 590d
Cleared Jan 04, 2023
Elecsys Anti-HCV II (08837031190)
K221693 · Roche Diagnostics
MZO · Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus · 208d
Cleared Dec 21, 2022
BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30)
K221826 · Becton, Dickinson and Company
JTN · Susceptibility Test Discs, Antimicrobial · 181d
Cleared Dec 20, 2022
IntelliSep test
K220991 · Cytovale, Inc.
QUT · Deformability Cytometry For Sepsis Risk Assessment · 260d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87