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
5934 Microbiology devices
3051–3075 of 5934
Cleared Sep 18, 1992
ENOXACIN 10 MCG. SENSI SISC
K923952 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 43d
Cleared Sep 17, 1992
BARTELS RUBELLA IGM EIA
K922581 · Baxter Diagnostics, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 113d
Cleared Sep 17, 1992
BARTELS RUBELLA IGG EIA
K922586 · Baxter Diagnostics, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 113d
Cleared Sep 14, 1992
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · Incstar Corp.
LSE · Epstein-barr Virus, Other · 161d
Cleared Sep 11, 1992
ROCHE ENTEROTUBE II
K922588 · Roche Diagnostic Systems, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 102d
Cleared Sep 11, 1992
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445 · Hycor Biomedical, Inc.
LYR · Helicobacter Pylori · 65d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGG EIA
K922330 · Baxter Diagnostics, Inc.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 112d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc.
LJN · Antibody Igm, If, Epstein-barr Virus · 112d
Cleared Sep 02, 1992
BARTELS EPSTEIN-BARR VIRUS IGG EIA
K922332 · Baxter Diagnostics, Inc.
LSE · Epstein-barr Virus, Other · 112d
Cleared Sep 02, 1992
BARTELS RUBEOLA IGM EIA
K922335 · Baxter Diagnostics, Inc.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 112d
Cleared Sep 02, 1992
BARTELS LYME DISEASE IGM EIA
K922578 · Baxter Diagnostics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 98d
Cleared Sep 02, 1992
BARTELS TOXOPLASMA IGM EIA
K922579 · Baxter Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 98d
Cleared Sep 02, 1992
BARTELS TOXOPLASMA IGG EIA
K922585 · Baxter Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 98d
Cleared Aug 20, 1992
BIOSTARS STREP A OIA -- MODIFICATION
K922765 · Biosearch Medical Products, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 79d
Cleared Aug 20, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922780 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 72d
Cleared Aug 19, 1992
ANTIMICROBIAL SUSCETIBILITY TEST PANEL
K922003 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 112d
Cleared Aug 11, 1992
ORTHO CHLAMYDIA ANTIGEN ELISA TEST
K921321 · Ortho Diagnostic Systems, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 148d
Cleared Aug 11, 1992
CMV-VUE(TM) CMV ANTIGEN DETECTION KIT
K921616 · Incstar Corp.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 127d
Cleared Jul 30, 1992
LEGIONELLA STAT IGG/IGM TEST KIT
K911356 · Whittaker Bioproducts, Inc.
MJH · Legionella, Spp., Elisa · 490d
Cleared Jul 30, 1992
PERMIER HISTOPLASMA
K915700 · Meridian Diagnostics, Inc.
MIZ · Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum · 220d
Cleared Jul 30, 1992
TURKEL THORACENTESIS NEEDLE
K921461 · Symbiosis Corp.
GSS · Antisera, Fluorescent, Pseudomonas Aeruginosa · 125d
Cleared Jul 30, 1992
ZITHROMAX
K922792 · Difco Laboratories, Inc.
JNT · Chromatographic, Phospholipids · 51d
Cleared Jul 28, 1992
LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY
K921421 · Pro-Lab, Inc.
LHL · Reagents, Antibody, Legionella, Direct & Indirect Fluorescent · 126d
Cleared Jul 28, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K922168 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 81d
Cleared Jul 28, 1992
LORACARBEF 30MCG DISK
K922791 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 49d

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All categories 5934 JWY Manual Antimicrobial Susceptibility Test Systems 408 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 75