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

7061
Total
6999
Cleared
155d
Avg (2y)
1976
Since
4573 Microbiology devices
326–350 of 4573
Cleared Apr 03, 2023
iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)
K221802 · Mawi Dna Technologies
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 286d
Cleared Mar 24, 2023
BD BACTEC™ Plus Aerobic/F Culture Vials
K222591 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 210d
Cleared Mar 24, 2023
BD BACTEC™ Myco/F Lytic Culture Vials
K222559 · Becton, Dickinson and Company
MDB · System, Blood Culturing · 212d
Cleared Mar 23, 2023
MeMed BV
K222332 · MeMed Diagnostics, Ltd.
QPS · Immunoassay For Host Biomarkers Of Infection · 233d
Cleared Mar 22, 2023
BioFire Global Fever Special Pathogens Panel
K213362 · Biofire Defense, LLC
QVR · Multiplex Nucleic Acid Detection System For Biothreat Agents · 526d
Cleared Mar 21, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae)
K223844 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 89d
Cleared Mar 20, 2023
Colibrí
K223245 · Copan Wasp Srl
QQV · Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry · 151d
Cleared Mar 17, 2023
Simplexa COVID-19 & Flu A/B Direct
K220963 · Diasorin Molecular, LLC
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 350d
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

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All categories 4573 JWY Manual Antimicrobial Susceptibility Test Systems 361 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 282 JTN Susceptibility Test Discs, Antimicrobial 276 JSJ Culture Media, Selective And Non-differential 232 JSI Culture Media, Selective And Differential 175 JSG Culture Media, Non-selective And Non-differential 168 JTO Discs, Strips And Reagents, Microorganism Differentiation 144 JSH Culture Media, Non-selective And Differential 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 75 GRM Antisera, All Groups, Salmonella Spp. 66 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 62 GTZ Antisera, All Groups, Streptococcus Spp. 59 JSF Culture Media, Single Biochemical Test 58 MDB System, Blood Culturing 54 GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. 51