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

7067
Total
7005
Cleared
149d
Avg (2y)
1976
Since
5926 Microbiology devices
601–625 of 5926
Cleared Mar 22, 2019
MTS Gentamicin 0.016 - 256 µg/mL
K190252 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 43d
Cleared Mar 19, 2019
MTS Ciprofloxacin 0.002 - 32 µg/mL
K183527 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 90d
Cleared Mar 18, 2019
ID NOW Influenza A & B 2
K190204 · Alere Scarborough, Inc.
OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 42d
Cleared Mar 18, 2019
Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application
K181599 · Beckman Coulter
QFS · Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment · 273d
Cleared Mar 14, 2019
Vstrip H. pylori Antigen Rapid Test
K183573 · Panion & BF Biotech, Inc.
LYR · Helicobacter Pylori · 83d
Cleared Mar 12, 2019
VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
K183524 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 83d
Cleared Mar 12, 2019
BioPlex 2200 Lyme Total
K183446 · Bio-Rad Laboratories
LSR · Reagent, Borrelia Serological Reagent · 90d
Cleared Mar 12, 2019
Endotoxin Activity Assay (EAA)
K183176 · Spectral Medical, Inc.
NGS · Assay, Endotoxin Activity, Chemiluminescent · 116d
Cleared Mar 07, 2019
VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)
K183551 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 77d
Cleared Mar 06, 2019
GenePOC Strep A
K183366 · Genepoc, Inc.
PGX · Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System · 92d
Cleared Feb 26, 2019
VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)
K183360 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 84d
Cleared Feb 20, 2019
VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)
K183415 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 72d
Cleared Feb 15, 2019
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL
K183324 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Feb 12, 2019
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL)
K183127 · Beckman Coulter, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 91d
Cleared Feb 11, 2019
BacT/ALERT FA Plus
K183166 · bioMerieux, Inc.
MDB · System, Blood Culturing · 88d
Cleared Feb 04, 2019
Capture-CMV
K183571 · Immucor, Inc.
LJO · Antigen, Iha, Cytomegalovirus · 45d
Not Cleared Jan 23, 2019
Aptima Mycoplasma genitalium Assay
DEN180047 · Hologic, Inc.
QEP · Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections · 145d
Cleared Jan 18, 2019
HardyDisk AST Omadacycline 30µg (OMC30)
K183298 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 52d
Cleared Jan 11, 2019
MTS Tetracycline 0.016 - 256 ug/mL
K183140 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 59d
Cleared Jan 11, 2019
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
K183031 · Biomerieux S.A.
JWY · Manual Antimicrobial Susceptibility Test Systems · 71d
Cleared Jan 08, 2019
BD MAX CTGCTV2, BD MAX System
K182692 · Becton, Dickinson and Company
OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 103d
Cleared Jan 04, 2019
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
K183033 · Thermo Fisher Scientific
JWY · Manual Antimicrobial Susceptibility Test Systems · 64d
Cleared Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K182690 · Genmark Diagnostics, Incorporated
PEO · Fungal Organisms, Nucleic Acid-based Assay · 85d
Cleared Dec 21, 2018
VITEK MS
K181412 · bioMerieux, Inc.
QBN · Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates · 205d
Cleared Dec 20, 2018
MTS Levofloxacin 0.002 - 32 µg/mL
K183115 · Liofilchem S. R. L.
JWY · Manual Antimicrobial Susceptibility Test Systems · 41d

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All categories 5926 JWY Manual Antimicrobial Susceptibility Test Systems 407 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74