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
1626–1650 of 5928
Cleared Apr 29, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML
K050747 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 38d
Cleared Apr 14, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML
K050555 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 42d
Cleared Apr 12, 2005
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc.
LJN · Antibody Igm, If, Epstein-barr Virus · 252d
Cleared Mar 29, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN
K050043 · Dade Behring, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 78d
Cleared Mar 22, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML
K050400 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 34d
Cleared Mar 18, 2005
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE
K050585 · Dade Behring, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 11d
Cleared Mar 16, 2005
IMMUNOCARD STAT! FLU A & B
K041626 · Meridian Bioscience, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 273d
Cleared Mar 15, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML
K043458 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 90d
Cleared Mar 14, 2005
GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
K043144 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 119d
Cleared Feb 28, 2005
VITEK 2 GRAM POSITIVE DAPTOMYCIN
K050075 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 47d
Cleared Feb 28, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML
K050089 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 45d
Cleared Feb 18, 2005
VITEK 2 GRAM POSITIVE ERTAPENEM
K050076 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 37d
Cleared Feb 17, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML)
K043545 · Dade Behring, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 56d
Cleared Feb 17, 2005
VITEK 2 COMPACT
K050002 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 45d
Cleared Feb 14, 2005
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
K043589 · Dade Microscan, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 48d
Cleared Feb 10, 2005
GEMIFLOXACIN, 5UG BBL SENSI-DISC
K050062 · Becton, Dickinson & CO
JTN · Susceptibility Test Discs, Antimicrobial · 30d
Cleared Jan 27, 2005
GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS
K043072 · Gen-Probe, Inc.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 80d
Cleared Jan 21, 2005
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML
K043389 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 43d
Cleared Dec 30, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM
K043230 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 38d
Cleared Dec 23, 2004
VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN
K043237 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 31d
Cleared Dec 13, 2004
HELICOBACTER PYLORI IGG ELISA
K041238 · Biohit Plc
LYR · Helicobacter Pylori · 216d
Cleared Dec 13, 2004
DAPTOMYCIN
K042392 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 102d
Cleared Dec 13, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM
K042963 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 47d
Cleared Dec 07, 2004
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
K042946 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 42d
Cleared Dec 07, 2004
COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
K042970 · Copan Diagnostics, Inc.
JSM · Culture Media, Non-propagating Transport · 40d

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All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 JTN Susceptibility Test Discs, Antimicrobial 316 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 284 JSJ Culture Media, Selective And Non-differential 264 JSI Culture Media, Selective And Differential 216 JTO Discs, Strips And Reagents, Microorganism Differentiation 194 JSG Culture Media, Non-selective And Non-differential 181 JSH Culture Media, Non-selective And Differential 115 LSR Reagent, Borrelia Serological Reagent 98 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 94 GTZ Antisera, All Groups, Streptococcus Spp. 84 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 79 JSM Culture Media, Non-propagating Transport 77 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74