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
251–275 of 363
Cleared Oct 31, 2023
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml
K232310 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 90d
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · DiaSorin, Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 182d
Cleared Oct 23, 2023
VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin
K232201 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 90d
Cleared Oct 19, 2023
Xpert Xpress MVP
K231381 · Cepheid
PQA · Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System · 160d
Cleared Oct 13, 2023
Xpert® Xpress CoV-2 plus
K230440 · Cepheid
QQX · Respiratory Specimen Nucleic Acid Sars-cov-2 Test · 234d
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 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 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 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 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 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
Cleared Jun 01, 2023
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
K231306 · Roche Molecular Systems, Inc.
QQX · Respiratory Specimen Nucleic Acid Sars-cov-2 Test · 27d
Cleared Jun 01, 2023
HardyDisk AST Rezafungin 5µg (RZF5)
K230827 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 66d
Cleared May 18, 2023
ComASP Cefiderocol 0.008-128
K230479 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d

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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 JTN Susceptibility Test Discs, Antimicrobial 13 QYT Over-the-counter Covid-19 Antigen Test 13 JSM Culture Media, Non-propagating Transport 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