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

1551–1575 of 5928

Cleared May 08, 2006

S. AUREUS PNA FISH

K060099 · Advandx, Inc.

NXX · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus · 115d

Cleared May 01, 2006

K052708 · Arj Medical, Inc.

LYR · Helicobacter Pylori · 214d

Cleared Apr 26, 2006

C. DIFF QUIK CHEK

K053572 · Techlab, Inc.

MCB · Antigen, C. Difficile · 125d

Cleared Apr 26, 2006

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)

K060447 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 64d

Cleared Apr 21, 2006

SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-

K060621 · Tds Holdings, Inc.

JWY · Manual Antimicrobial Susceptibility Test Systems · 44d

Cleared Apr 14, 2006

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

K060257 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 72d

Cleared Apr 12, 2006

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML

K060217 · Becton, Dickinson & CO

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

Cleared Apr 12, 2006

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML

K060444 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 50d

Cleared Mar 29, 2006

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA.

K060493 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 33d

Cleared Mar 23, 2006

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML)

K060312 · Dade Behring, Inc.

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

Cleared Mar 17, 2006

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML

K060218 · Becton, Dickinson & CO

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

Cleared Mar 17, 2006

TIGECYCLINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

K060286 · Oxoid , Ltd.

JTN · Susceptibility Test Discs, Antimicrobial · 42d

Cleared Mar 10, 2006

PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480

K053335 · Meridian Bioscience, Inc.

LYR · Helicobacter Pylori · 99d

Cleared Mar 09, 2006

BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML

K060214 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 41d

Cleared Feb 24, 2006

MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML)

K053504 · Dade Behring, Inc.

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

Cleared Feb 21, 2006

GENZYME OSOM INFLUENZA A & B TEST

K051244 · Genzyme Corp.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 281d

Cleared Feb 08, 2006

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

K052499 · Diasorin S.P.A

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 148d

Cleared Feb 03, 2006

MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN

K060088 · Dade Behring, Inc.

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

Not Cleared Feb 03, 2006

INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET

DEN060008 · Centers For Disease Control and Prevention

NXD · Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna · 7d

Cleared Jan 20, 2006

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

K053243 · Trek Diagnostic Systems, Inc.

LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 60d

Cleared Jan 19, 2006

VERSATREK MYCO PZA KIT

K052323 · Trek Diagnostic Systems, Inc.

MJA · Susceptibility Test Powders, Antimycobacterial · 147d

Cleared Jan 17, 2006

SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF

K052485 · Midi, Inc.

NWZ · Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids · 130d

Cleared Dec 22, 2005

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML

K053241 · Becton, Dickinson & CO

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 34d

Cleared Dec 14, 2005

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323

K052645 · Ortho-Clinical Diagnostics

GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 79d

Cleared Dec 14, 2005

VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN

K053097 · bioMerieux, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 41d

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