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

901–925 of 1404

Cleared Jul 17, 2002

MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML)

K020413 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 160d

Cleared Jun 11, 2002

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML)

K020410 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 124d

Cleared May 16, 2002

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

K020398 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 99d

Cleared May 09, 2002

MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME

K020820 · Dade Behring, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 57d

Cleared May 08, 2002

MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN

K020822 · Dade Behring, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 56d

Cleared May 06, 2002

MICROSTREP PLUS PANEL WITH AMPICILLIN

K021037 · Dade Behring, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 35d

Cleared Apr 26, 2002

BACT/ALERT SN CULTURE BOTTLE

K021123 · bioMerieux, Inc.

MDB · System, Blood Culturing · 18d

Cleared Apr 22, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML)

K020397 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 75d

Cleared Apr 18, 2002

BACT/ALERT FN CULTURE BOTTLE

K020815 · bioMerieux, Inc.

MDB · System, Blood Culturing · 36d

Cleared Apr 18, 2002

BACT/ALERT PF CULTURE BOTTLE

K020923 · bioMerieux, Inc.

MDB · System, Blood Culturing · 28d

Cleared Apr 18, 2002

BACT/ALERT SA CULTURE BOTTLE

K020931 · bioMerieux, Inc.

MDB · System, Blood Culturing · 27d

Cleared Apr 17, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML)

K020319 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 77d

Cleared Apr 17, 2002

BACT/ALERT FA CULTURE BOTTLE

K020813 · bioMerieux, Inc.

MDB · System, Blood Culturing · 35d

Cleared Mar 29, 2002

VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN

K020871 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 91d

Cleared Mar 25, 2002

VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN

K020870 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 87d

Cleared Mar 14, 2002

MICROSCAN SYNERGIES PLUS

K020142 · Dade Behring, Inc.

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

Cleared Mar 14, 2002

DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN

K020160 · Dade Behring, Inc.

LTT · Panels, Test, Susceptibility, Antimicrobial · 56d

Cleared Mar 14, 2002

DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN

K020162 · Dade Behring, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 56d

Cleared Mar 14, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML)

K020248 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d

Cleared Feb 19, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML)

K020328 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d

Cleared Feb 06, 2002

MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)

K020168 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 20d

Cleared Feb 06, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML)

K020173 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 20d

Cleared Feb 06, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML)

K020182 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d

Cleared Feb 06, 2002

MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML)

K020185 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 19d

Cleared Feb 06, 2002

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

K020209 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 15d

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