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

7067

Total

7005

Cleared

149d

Avg (2y)

1976

Since

5928 Microbiology devices

1726–1750 of 5928

Cleared Sep 17, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE

K032567 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 28d

Cleared Sep 11, 2003

QUICKVUE INFLUENZA A+B TEST

K031899 · Quidel Corp.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 99d

Cleared Sep 10, 2003

VITEK 2 GRAM POSITIVE MOXIFLOXACIN

K032399 · bioMerieux, Inc.

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

Cleared Aug 29, 2003

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES

K032382 · Trek Diagnostic Systems, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 28d

Cleared Aug 27, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML

K031984 · Becton, Dickinson & CO

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

Cleared Aug 22, 2003

K032306 · Trek Diagnostic Systems, Inc.

MDB · System, Blood Culturing · 28d

Cleared Aug 22, 2003

VITEK 2 GRAM POSITIVE GATIFLOXACIN

K032314 · bioMerieux, Inc.

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

Cleared Aug 18, 2003

BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS

K032131 · Becton, Dickinson & CO

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

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 Aug 06, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML

K031943 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 43d

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 30, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML

K031699 · Becton, Dickinson & CO

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

Cleared Jul 30, 2003

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN

K031727 · Pasco Laboratories, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 57d

Cleared Jul 21, 2003

BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML

K031912 · Becton, Dickinson & CO

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

Cleared Jul 17, 2003

XPECT INFLUENZA A/B

K031565 · Remel, Inc.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 59d

Cleared Jul 16, 2003

SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE

K031545 · Trek Diagnostic Systems, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 61d

Cleared Jul 16, 2003

BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM

K031679 · Becton, Dickinson & CO

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

Cleared Jul 14, 2003

BACT/ALERT MP CULTURE BOTTLES (PLASTIC)

K031737 · bioMerieux, Inc.

MDB · System, Blood Culturing · 40d

Cleared Jul 14, 2003

ACON STREP A RAPID TEST DEVICE

K031784 · ACON Laboratories, Inc.

GTY · Antigens, All Groups, Streptococcus Spp. · 34d

Cleared Jul 11, 2003

C. DIFF CHEK - 30

K030991 · Techlab, Inc.

LLH · Reagents, Clostridium Difficile Toxin · 105d

Cleared Jul 11, 2003

C. DIFF CHEK - 60

K030992 · Techlab, Inc.

LLH · Reagents, Clostridium Difficile Toxin · 105d

Cleared Jul 11, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE

K031589 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 51d

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 Jul 10, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML

K031530 · Becton, Dickinson & CO

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

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