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
5936 Microbiology devices
3251–3275 of 5936
Cleared Feb 26, 1991
M. CAT. BUTYRATE DISC
K905666 · Carr-Scarborough Microbiologicals, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 70d
Cleared Feb 26, 1991
ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL
K910416 · Abbott Laboratories
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 27d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc.
LJN · Antibody Igm, If, Epstein-barr Virus · 48d
Cleared Feb 20, 1991
NITRATE DISK
K905163 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 96d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPT TEST PANEL/ADD ANTIBIOTICS
K904689 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 120d
Cleared Feb 07, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K905853 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 51d
Cleared Jan 30, 1991
MERISTAR-MP
K905493 · Meridian Diagnostics, Inc.
GSA · Antisera, All Mycoplasma Spp. · 54d
Cleared Jan 28, 1991
RAPITEX(R) ASL NEW
K903854 · Behring Diagnostics, Inc.
GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 160d
Cleared Jan 28, 1991
DYNATECH MR4000 MICROPLATE READER
K904567 · Dynatech Corp.
JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use · 111d
Cleared Jan 28, 1991
SLIDEX STREPTO-KIT
K905020 · Vitek Systems, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 82d
Cleared Jan 25, 1991
PREMIER-CRYPTOCOCCAL ANTIGEN
K904393 · Meridian Diagnostics, Inc.
MDU · Antigen, Elisa, Cryptococcus · 122d
Cleared Jan 25, 1991
VANCOMYCIN DISK-5 MCG
K905151 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 71d
Cleared Jan 24, 1991
E. COLI 0157 LATEX TEST
K903714 · Pro-Lab, Inc.
GNA · Antisera, All Types, Escherichia Coli · 163d
Cleared Jan 18, 1991
GASTRO-INTESTINAL ACCU-CULSHURE TM
K903638 · Medical Laboratory Automation Systems, Inc.
LIO · Device, Specimen Collection · 158d
Cleared Jan 18, 1991
KODAK SURECELL(TM) STREP A CONTROL FLUID SET
K904589 · Eastman Kodak Company
GTY · Antigens, All Groups, Streptococcus Spp. · 101d
Cleared Jan 14, 1991
CHLAMYDIA SYSTEM SOFTWARE (CSS)
K904725 · Kallestad Diag, A Div. of Erbamont, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 89d
Cleared Jan 08, 1991
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · Diagnostic Chemicals, Ltd. (Usa)
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 454d
Cleared Jan 03, 1991
RUBEOLA IGM ELISA TEST
K904083 · Gull Laboratories, Inc.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 120d
Cleared Dec 28, 1990
MEASLES IGG MICROASSAY
K903961 · Diamedix Corp.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 122d
Cleared Dec 26, 1990
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · Diagnostic Chemicals, Ltd. (Usa)
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 441d
Cleared Dec 26, 1990
CAPTIA(R) SYPHILIS M, MODIFICATION
K904524 · Mercia Diagnostics , Ltd.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 90d
Cleared Dec 21, 1990
ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF
K903132 · Ortho Diagnostic Systems, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 157d
Cleared Dec 21, 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL/MODIFIED
K904523 · Alamar Biosciences Laboratory, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 86d
Cleared Dec 18, 1990
TOXO-CUBE
K903968 · Difco Laboratories, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 112d
Cleared Dec 17, 1990
CMV IGM ELISA TEST
K903807 · Gull Laboratories, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 119d

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All categories 5936 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 99 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