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

7095

Total

7032

Cleared

150d

Avg (2y)

1976

Since

7095 Microbiology devices

1801–1825 of 7095

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 24, 2003

BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG

K032713 · Boston Biomedica, Inc.

LSR · Reagent, Borrelia Serological Reagent · 83d

Cleared Nov 18, 2003

XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020

K031942 · Remel, Inc.

MHI · Giardia Spp. · 147d

Cleared Nov 18, 2003

PASCO MIC AND MIC/ID PANELS

K033119 · Pasco Laboratories, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 49d

Cleared Nov 14, 2003

XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

K031965 · Remel, Inc.

MHJ · Cryptosporidium Spp. · 141d

Cleared Nov 12, 2003

VITEK 2 GRAM NEGATIVE MOXIFLOXACIN

K032861 · bioMerieux, Inc.

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

Cleared Nov 10, 2003

XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

K031834 · Remel, Inc.

MHI · Giardia Spp. · 150d

Cleared Nov 04, 2003

VITEK 2 GRAM NEGATIVE GATIFLOXACIN

K032788 · bioMerieux, Inc.

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

Cleared Nov 04, 2003

K033274 · Techlab, Inc.

MHI · Giardia Spp. · 25d

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 Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC IGM CONTROLS

K032993 · Ortho-Clinical Diagnostics, Inc.

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 36d

Cleared Oct 31, 2003

VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC CONTROLS

K033127 · Ortho-Clinical Diagnostics

JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 31d

Cleared Oct 22, 2003

WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M

K031952 · Focus Technologies, Inc.

NOP · Elisa, Antibody, West Nile Virus · 119d

Cleared Oct 22, 2003

WEST NILE VIRUS ELISA IGG, MODEL EL0300G

K031953 · Focus Technologies, Inc.

NOP · Elisa, Antibody, West Nile Virus · 119d

Cleared Oct 21, 2003

BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065

K032166 · Binax, Inc.

GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 97d

Cleared Oct 06, 2003

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

K032655 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 39d

Cleared Sep 29, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS

K032275 · Becton, Dickinson & CO

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

Cleared Sep 22, 2003

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML

K032299 · Becton, Dickinson & CO

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

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 15, 2003

PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN (STREP)

K032518 · Bd Diagnostic Systems

JWY · Manual Antimicrobial Susceptibility Test Systems · 32d

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 11, 2003

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

K032153 · Bd Diagnostic Systems

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

Cleared Sep 10, 2003

VITEK 2 GRAM POSITIVE MOXIFLOXACIN

K032399 · bioMerieux, Inc.

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

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