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
351–363 of 363
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 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
Not Cleared Mar 17, 2021
BioFire Respiratory Panel 2.1 (RP2.1)
DEN200031 · Biofire Diagnostics, LLC
QOF · Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents · 302d
Cleared Mar 03, 2021
Cultura Collection and Transport System
K201674 · Merit Medical Systems, Inc.
JSM · Culture Media, Non-propagating Transport · 257d
Cleared Feb 18, 2021
LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus
K202573 · DiaSorin, Inc.
LSR · Reagent, Borrelia Serological Reagent · 167d
Cleared Feb 18, 2021
LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus
K202574 · DiaSorin, Inc.
LSR · Reagent, Borrelia Serological Reagent · 167d
Cleared Feb 16, 2021
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
K210234 · Roche Molecular Systems, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 19d
Cleared Feb 09, 2021
LIAISON Anti-HAV
K210272 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 8d
Cleared Jan 29, 2021
cobas BKV
K203220 · Roche Molecular Systems, Inc.
QLX · Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna · 88d
Cleared Jan 21, 2021
cobas CTNG for use on cobas 6800/8800 systems
K202408 · Roche Molecular Systems, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 153d

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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 JSM Culture Media, Non-propagating Transport 13 JTN Susceptibility Test Discs, Antimicrobial 13 QYT Over-the-counter Covid-19 Antigen Test 13 SCA Multi-analyte Respiratory Virus Antigen Detection Test 11 PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays 10 QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test 8 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 NGZ Susceptibility Test Plate, Antifungal 7 PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System 6 LOL Hepatitis A Test (antibody And Igm Antibody) 6