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
326–350 of 7095
Cleared Sep 28, 2023
DNA/RNA Shield SafeCollect Saliva Collection kit
K231013 · Zymo Research
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 171d
Cleared Sep 27, 2023
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · Cepheid
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 391d
Cleared Sep 20, 2023
ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
K213987 · Biokit, S.A.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 639d
Cleared Sep 15, 2023
T2 Biothreat Panel
K231336 · T2biosystems, Inc.
QVR · Multiplex Nucleic Acid Detection System For Biothreat Agents · 130d
Cleared Aug 31, 2023
The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL
K231433 · Thermo Fisher Scientific
NGZ · Susceptibility Test Plate, Antifungal · 106d
Cleared Aug 31, 2023
BD Kiestra IdentifA
K222563 · Becton, Dickinson and Company
QQV · Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry · 372d
Cleared Aug 30, 2023
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml
K231988 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 56d
Cleared Aug 25, 2023
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL
K231994 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 51d
Cleared Aug 17, 2023
Xpert Xpress CoV-2/Flu/RSV plus
K231481 · Cepheid
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 86d
Cleared Aug 10, 2023
HAVAb IgG II
K222850 · Abbott Laboratories
LOL · Hepatitis A Test (antibody And Igm Antibody) · 323d
Cleared Aug 10, 2023
ID NOW COVID-19 2.0
K221925 · Abbott Diagnostics Scarborough, Inc.
QWR · Simple Point-of-care Device To Detect Sar-cov-2 Nucleic Acid Targets From Clinical Specimens In Near-patient Settings · 405d
Cleared Jul 31, 2023
BD Respiratory Viral Panel for BD MAX™ System
K230956 · Bd Integrated Diagnostic Solutions /
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 118d
Cleared Jul 27, 2023
MDx-Chex for BC-GN
K231223 · Streck
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 90d
Cleared Jul 27, 2023
MDx-Chex for BC-GP
K231221 · Streck
PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 90d
Cleared Jul 27, 2023
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
K223591 · Roche Molecular Systems, Inc.
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 238d
Cleared Jul 13, 2023
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System
K230863 · Zeus Scientific
LSR · Reagent, Borrelia Serological Reagent · 106d
Cleared Jul 06, 2023
HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20)
K231568 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 36d
Cleared Jul 05, 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
K230864 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 98d
Cleared Jul 03, 2023
Premier HpSA Flex (619096)
K230901 · Meridian Bioscience, Inc.
LYR · Helicobacter Pylori · 94d
Cleared Jul 03, 2023
CLEARinse CTS Specimen Collection and Transport System
K221664 · Aardvark Medical, Inc.
QBD · Microbial Nucleic Acid Storage And Stabilization Device · 390d
Cleared Jun 30, 2023
MeMed BV
K230944 · MeMed Diagnostics, Ltd.
QPS · Immunoassay For Host Biomarkers Of Infection · 87d
Cleared Jun 30, 2023
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae)
K230935 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 88d
Cleared Jun 30, 2023
FebriDx Bacterial / Non-bacterial Point of Care Assay
K230917 · Lumos Diagnostics, Inc.
QXA · Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection · 88d
Cleared Jun 26, 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 325d
Cleared Jun 07, 2023
BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20)
K230651 · Becton, Dickinson and Company
JTN · Susceptibility Test Discs, Antimicrobial · 90d

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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