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

7048

Total

6986

Cleared

159d

Avg (2y)

1976

Since

1404 Microbiology devices

576–600 of 1404

Cleared Apr 25, 2019

Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

K190771 · Cepheid

NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 30d

Cleared Apr 22, 2019

FluChip-8G Influenza A+B Assay

K182513 · Indevr, Inc.

OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay · 222d

Cleared Apr 19, 2019

Cepheid Xpert C. difficile/Epi Control Panel

K190463 · Microbiologics, Inc.

PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 52d

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

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 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 14, 2019

Vstrip H. pylori Antigen Rapid Test

K183573 · Panion & BF Biotech, Inc.

LYR · Helicobacter Pylori · 83d

Cleared Mar 12, 2019

Endotoxin Activity Assay (EAA)

K183176 · Spectral Medical, Inc.

NGS · Assay, Endotoxin Activity, Chemiluminescent · 116d

Cleared Mar 12, 2019

BioPlex 2200 Lyme Total

K183446 · Bio-Rad Laboratories

LSR · Reagent, Borrelia Serological Reagent · 90d

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 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

ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

K183031 · Biomerieux S.A.

JWY · Manual Antimicrobial Susceptibility Test Systems · 71d

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