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

876–900 of 1404

Cleared Apr 02, 2004

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

K031601 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 317d

Cleared Mar 01, 2004

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN)

K033948 · Dade Behring, Inc.

LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 73d

Cleared Feb 25, 2004

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)

K033940 · Dade Behring, Inc.

LTT · Panels, Test, Susceptibility, Antimicrobial · 68d

Cleared Feb 10, 2004

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML

K032706 · Dade Behring, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 161d

Cleared Nov 26, 2003

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML)

K033482 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 22d

Cleared Nov 12, 2003

VITEK 2 GRAM NEGATIVE MOXIFLOXACIN

K032861 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 61d

Cleared Nov 04, 2003

VITEK 2 GRAM NEGATIVE GATIFLOXACIN

K032788 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d

Cleared Oct 31, 2003

VITEK GRAM NEGATIVE GATIFLOXACIN

K032711 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 59d

Cleared Oct 31, 2003

VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN

K032738 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d

Cleared Oct 31, 2003

VITEK 2 GRAM POSITIVE LINEZOLID

K032766 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 56d

Cleared Sep 10, 2003

VITEK 2 GRAM POSITIVE MOXIFLOXACIN

K032399 · bioMerieux, Inc.

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

Cleared Aug 22, 2003

VITEK 2 GRAM POSITIVE GATIFLOXACIN

K032314 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 25d

Cleared Aug 13, 2003

VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE

K031865 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d

Cleared Aug 08, 2003

ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY

K032162 · Beckman Coulter, Inc.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 24d

Cleared Jul 31, 2003

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML)

K031602 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 71d

Cleared Jul 14, 2003

BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

K031737 · bioMerieux, Inc.

MDB · System, Blood Culturing · 40d

Cleared Jul 10, 2003

VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE

K031410 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 66d

Cleared Jun 20, 2003

ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY

K031606 · Beckman Coulter, Inc.

LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 29d

Cleared Jun 02, 2003

ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY

K031506 · Beckman Coulter, Inc.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 19d

Cleared May 16, 2003

PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794

K023857 · Bio-Rad

NOM · Antigen, Galactomannan, Aspergillus Spp. · 177d

Cleared Dec 16, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML)

K023361 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 70d

Cleared Dec 13, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML)

K023541 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 52d

Cleared Sep 30, 2002

BIO-RAD PLATELIA TOXO IGM TMB

K013837 · Bio-Rad

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 315d

Cleared Sep 30, 2002

BIO-RAD PLATELIA TOXO IGG TMB

K013839 · Bio-Rad

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 315d

Cleared Aug 15, 2002

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID

K022045 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 52d

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