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
3026–3050 of 5934
Cleared Dec 03, 1992
REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK
K925060 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 58d
Cleared Nov 30, 1992
ANTIMICROBIAL SUSCEPTIBILITY TEST
K924500 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 87d
Cleared Nov 30, 1992
REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK
K924846 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 63d
Cleared Nov 02, 1992
NIZYME TEST KIT
K923566 · Remel Co.
JSX · Kit, Identification, Neisseria Gonorrhoeae · 108d
Cleared Nov 02, 1992
CEFPODOXIME 10 MCG, SENSI DISC
K924797 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 39d
Cleared Oct 26, 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K923122 · Biomerieux Vitek, Inc.
LFY · Enzyme Linked Immunoabsorbent Assay, Varicella-zoster · 122d
Cleared Oct 26, 1992
REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K924765 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 33d
Cleared Oct 26, 1992
REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK
K924766 · Remel Co.
JTN · Susceptibility Test Discs, Antimicrobial · 33d
Cleared Oct 21, 1992
Q FEVER IGG IFA TEST
K913906 · Hillcrest Biologicals
GPJ · Antiserum, Fluorescent, Q Fever · 418d
Cleared Oct 21, 1992
Q FEVER IGM IFA TEST
K922374 · Hillcrest Biologicals
GPJ · Antiserum, Fluorescent, Q Fever · 154d
Cleared Oct 19, 1992
MERITEC C. DIFFICILE CONTROLS
K924062 · Meridian Diagnostics, Inc.
MCB · Antigen, C. Difficile · 68d
Cleared Oct 14, 1992
RAPID NFT, MODIFICATION
K922768 · Biomerieux Vitek, Inc.
JSW · Kit, Identification, Glucose Nonfermenter · 128d
Cleared Oct 13, 1992
API UNISCEPT KB/TYPE 2 AND 3
K922926 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 118d
Cleared Oct 05, 1992
HSV-1 IGM ELISA TEST -- MODIFICATION
K922758 · Gull Laboratories, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 119d
Cleared Oct 05, 1992
HSV-2 IGM ELISA TEST--MODIFICATION
K922759 · Gull Laboratories, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 119d
Cleared Oct 05, 1992
INDOXYL ACETATE DISK
K923700 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 73d
Cleared Oct 05, 1992
PREMIER BLASTOMYCES
K923859 · Meridian Diagnostics, Inc.
MJL · Eia, Blastomyces Dermatitidis · 66d
Cleared Oct 01, 1992
MICRO TRAK XL SYSTEM
K921747 · Syva Co.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 171d
Cleared Sep 28, 1992
BARTELS HERPES SIMPLEX VIRUS 2 IGG EIA
K922583 · Baxter Diagnostics, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 124d
Cleared Sep 28, 1992
SLIDEX STAPH-KIT
K923212 · Biomerieux Vitek, Inc.
JWX · Kit, Screening, Staphylococcus Aureus · 89d
Cleared Sep 28, 1992
LAP DISK
K923827 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 60d
Cleared Sep 25, 1992
SYVA MICROTRAK CHLAMYDIA EIA
K920503 · Syva Co.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 233d
Cleared Sep 25, 1992
MICROTRAK(R) II CHLAMYDIA EIA ASSAY
K921462 · Syva Co.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 182d
Cleared Sep 22, 1992
MICROBACT SOLID PLATE SYSTEMS
K923342 · Radiometer America, Inc.
JJS · Controls For Blood-gases, (assayed And Unassayed) · 98d
Cleared Sep 18, 1992
BARTELS HERPES SIMPLEX VIRUS 1 IGG EIA
K922584 · Baxter Diagnostics, Inc.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 114d

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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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75