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

626–650 of 7095

Cleared Apr 18, 2019

MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

K190109 · Beckman Coulter, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 85d

Cleared Apr 12, 2019

ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel

K182619 · Genmark Diagnostics, Incorporated

PEN · Gram-negative Bacteria And Associated Resistance Markers · 200d

Cleared Mar 27, 2019

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit

K190302 · Centers For Disease Control and Prevention

OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 43d

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

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

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