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

7061

Total

6999

Cleared

155d

Avg (2y)

1976

Since

4573 Microbiology devices

776–800 of 4573

Cleared Sep 27, 2016

Solana Influenza A+B Assay

K161814 · Quidel Corporation

OCC · Respiratory Virus Panel Nucleic Acid Assay System · 88d

Cleared Sep 06, 2016

BD MAX CT/GC/TV, BD MAX INSTRUMENT

K151589 · Becton, Dickinson and Company

OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 452d

Cleared Aug 29, 2016

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

K161619 · Cepheid

OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 77d

Cleared Aug 25, 2016

LIAISON HAV IgM, LIAISON Control HAV IgM

K160650 · DiaSorin, Inc.

LOL · Hepatitis A Test (antibody And Igm Antibody) · 170d

Cleared Aug 15, 2016

Solana Trichomonas Assay

K161182 · Quidel Corporation

OUY · Trichomonas Vaginalis Nucleic Acid Amplification Test System · 110d

Cleared Jul 28, 2016

Elecsys Syphilis

K160910 · Roche Diagnostics

LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 118d

Cleared Jul 22, 2016

LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set

K161139 · DiaSorin, Inc.

LYR · Helicobacter Pylori · 91d

Cleared Jul 20, 2016

VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)

K161227 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 79d

Cleared Jul 12, 2016

Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL

K161175 · Liofilchem S. R. L.

JWY · Manual Antimicrobial Susceptibility Test Systems · 77d

Cleared Jul 05, 2016

Lumipulse G TP-N Immunoreaction Cartridge Set

K153145 · Fujirebio Diagnostics,Inc.

LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 249d

Cleared Jun 30, 2016

LIAISON CMV IgM Serum Control Set

K161526 · DiaSorin, Inc.

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d

Cleared Jun 30, 2016

LIAISON EBV IgM Serum Control Set

K161522 · DiaSorin, Inc.

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 28d

Cleared Jun 29, 2016

K160901 · Cepheid

POC · System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen · 89d

Cleared Jun 28, 2016

VIDAS B.R.A.H.M.S. PCT (PCT)

K160911 · bioMerieux, Inc.

PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 88d

Cleared Jun 22, 2016

Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml

K153569 · Liofilchem S. R. L.

JWY · Manual Antimicrobial Susceptibility Test Systems · 190d

Cleared Jun 15, 2016

ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control

K153730 · Abbott Laboratories

LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 170d

Cleared Jun 13, 2016

illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

K160829 · Meridian Bioscience, Inc.

OZX · Mycoplasma Pneumoniae Dna Assay System · 80d

Cleared Jun 13, 2016

Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5

K160729 · Roche Diagnostics

PMT · Device To Detect And Measure Procalcitonin (pct) In Human Clinical Specimens · 89d

Cleared May 10, 2016

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

K152679 · Bio-Rad Laboratories

PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 235d

Cleared Apr 15, 2016

VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

K152075 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 263d

Cleared Mar 31, 2016

Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL

K153687 · Liofilchem S. R. L.

JWY · Manual Antimicrobial Susceptibility Test Systems · 99d

Not Cleared Mar 28, 2016

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

DEN150058 · Bio-Rad Laboratories

PMN · Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays · 103d

Cleared Mar 25, 2016

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)

K151923 · bioMerieux, Inc.

NGZ · Susceptibility Test Plate, Antifungal · 256d

Cleared Mar 14, 2016

ImmunoCard STAT! HpSA

K153661 · Meridian Bioscience, Inc.

LYR · Helicobacter Pylori · 84d

Cleared Mar 11, 2016

K151688 · bioMerieux, Inc.

JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 262d

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