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

1776–1800 of 5928

Cleared Dec 24, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)

K023634 · Becton, Dickinson & CO

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

Cleared Dec 23, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML

K023527 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 63d

Cleared Dec 20, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

K023858 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 30d

Cleared Dec 18, 2002

DFA RESPIRATORY VIRUS SCREENING & ID KIT

K022713 · Diagnostic Hybrids, Inc.

GNW · Antisera, Cf, Influenza Virus A, B, C · 126d

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 Dec 10, 2002

BD DIRECTIGEN EZ RSV KIT

K022133 · Becton, Dickinson & CO

GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 162d

Cleared Nov 12, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

K023301 · Becton, Dickinson & CO

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

Cleared Nov 12, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML

K023444 · Becton, Dickinson & CO

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

Cleared Oct 31, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML

K023273 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 30d

Cleared Oct 25, 2002

NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASSAY

K022356 · Nichols Institute Diagnostics

LYR · Helicobacter Pylori · 98d

Cleared Oct 23, 2002

MICROSCAN SYNERGIES PLUS

K023202 · Dade Microscan, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 28d

Cleared Oct 17, 2002

K023270 · Sa Scientific, Inc.

GTY · Antigens, All Groups, Streptococcus Spp. · 16d

Cleared Oct 08, 2002

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K022656 · Trek Diagnostic Systems, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 60d

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 Sep 25, 2002

SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

K021997 · Trek Diagnostic Systems, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 98d

Cleared Sep 25, 2002

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K022775 · Trek Diagnostic Systems, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 47d

Cleared Sep 19, 2002

BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

K021646 · Binax, Inc.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 122d

Cleared Sep 19, 2002

BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK

K021649 · Binax, Inc.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 122d

Cleared Sep 17, 2002

GEN-PROBE APTIMA COMBO 2 ASSAY

K022874 · Gen-Probe, Inc.

JTW · System, Transport, Aerobic · 53d

Cleared Sep 13, 2002

BINAX NOW RSV TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESSORY PACK

K021687 · Binax, Inc.

GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 114d

Cleared Aug 15, 2002

VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID

K022045 · bioMerieux, Inc.

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

Cleared Aug 12, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM

K022172 · Becton, Dickinson & CO

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

Cleared Aug 01, 2002

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML

K021954 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 48d

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