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

851–875 of 1404

Cleared Dec 14, 2005

VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN

K053097 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 41d

Cleared Dec 01, 2005

VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE

K053186 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 17d

Cleared Nov 07, 2005

VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN

K052656 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 42d

Cleared Oct 26, 2005

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

K052346 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 58d

Cleared Sep 29, 2005

VITEK 2 GRAM NEGATIVE TIGECYCLINE

K052311 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 36d

Cleared Aug 16, 2005

VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE

K051849 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 40d

Cleared Jul 27, 2005

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN

K051478 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 54d

Cleared Jul 25, 2005

SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS

K051350 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 62d

Cleared Jul 12, 2005

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN

K051311 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 54d

Cleared Jun 23, 2005

DRIED GRAM-POSITIVE MIC/COMBO PANELS

K051202 · Dade Behring, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 43d

Cleared May 23, 2005

VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE

K050976 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 35d

Cleared May 12, 2005

VITEK 2 GRAM POSITIVE MEROPENEM

K050816 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 42d

Cleared Mar 29, 2005

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN

K050043 · Dade Behring, Inc.

LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 78d

Cleared Mar 18, 2005

MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE

K050585 · Dade Behring, Inc.

LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 11d

Cleared Feb 28, 2005

VITEK 2 GRAM POSITIVE DAPTOMYCIN

K050075 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 47d

Cleared Feb 18, 2005

VITEK 2 GRAM POSITIVE ERTAPENEM

K050076 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 37d

Cleared Feb 17, 2005

MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)

K043545 · Dade Behring, Inc.

LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 56d

Cleared Feb 17, 2005

VITEK 2 COMPACT

K050002 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 45d

Cleared Dec 30, 2004

VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM

K043230 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 38d

Cleared Dec 23, 2004

VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN

K043237 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 31d

Cleared Dec 13, 2004

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM

K042963 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 47d

Cleared Dec 07, 2004

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN

K042946 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 42d

Cleared Sep 14, 2004

VITEK 2 GRAM NEGATIVE ERTAPENEM

K041982 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 53d

Cleared Jul 22, 2004

MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS

K041150 · Dade Behring, Inc.

LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 80d

Cleared Jun 08, 2004

VITEK 2 ESBL TEST

K040845 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 68d

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