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
150d
Avg (2y)
1976
Since
5941 Microbiology devices
4176–4200 of 5941
Cleared Jul 03, 1986
BIOTIS SXT AGAR
K862399 · Otisville Biotech, Inc.
JSJ · Culture Media, Selective And Non-differential · 9d
Cleared Jul 03, 1986
BIOTIS KV LAKED BLOOD AGAR
K862400 · Otisville Biotech, Inc.
JSJ · Culture Media, Selective And Non-differential · 9d
Cleared Jul 02, 1986
GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM
K860782 · Gen-Probe, Inc.
LQF · Dna-reagents, Mycobacterium Spp. · 121d
Cleared Jul 02, 1986
MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
K862425 · Gibco Laboratories Life Technologies, Inc.
JSI · Culture Media, Selective And Differential · 6d
Cleared Jul 01, 1986
ROTAVIRUS LATEX AGGLUTINATION ASSAY
K861172 · Bartels Immunodiagnostic Supplies, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 95d
Cleared Jun 30, 1986
TOXOPLASMA GONDII IGG EIA TEST KIT (AMENDMENT)
K862216 · Labsystems, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 20d
Cleared Jun 17, 1986
RUBELLA IGG EIA TEST KIT
K853696 · Labsystems, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 285d
Cleared Jun 17, 1986
GRAM NEGATIVE COMBO PANEL TYPE 3
K861584 · American Micro Scan
JWY · Manual Antimicrobial Susceptibility Test Systems · 49d
Cleared Jun 16, 1986
SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL
K861187 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JWY · Manual Antimicrobial Susceptibility Test Systems · 77d
Cleared Jun 16, 1986
BIOSPHERE ANAEROBIC ENVIRONMENTAL DEVICE
K862123 · Marion Laboratories, Inc.
KZJ · Device, Gas Generating · 13d
Cleared Jun 13, 1986
COR DOT CMV
K853989 · Cordis Corp.
GQI · Antiserum, Cf, Cytomegalovirus · 259d
Cleared Jun 13, 1986
SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL
K861186 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JWY · Manual Antimicrobial Susceptibility Test Systems · 74d
Cleared Jun 13, 1986
MICROSCOPE SLIDES
K862112 · Abco Dealers, Inc.
LIB · Device, General Purpose, Microbiology, Diagnostic · 10d
Cleared Jun 10, 1986
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc.
JXA · Kit, Screening, Urine · 42d
Cleared Jun 10, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE
K861997 · Hazleton Research Products, Inc.
JSK · Supplement, Culture Media · 18d
Cleared Jun 05, 1986
TITERTEK MICROPLATE WASHER S-12
K862066 · Flow Laboratories, Inc.
JTC · Device, Microtiter Diluting/dispensing · 6d
Cleared Jun 04, 1986
RUBALEX (REVISED VERSION)
K861881 · Orion Corp.
LQN · Latex Agglutination Assay, Rubella · 27d
Cleared Jun 03, 1986
DIRECTATEX STREP A
K861575 · Pacific Biotech, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 36d
Cleared Jun 03, 1986
HIPPURATE HYDROLYSIS TEST
K861888 · Pro-Lab, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 18d
Cleared Jun 03, 1986
D'ALA RAPID TEST
K861889 · Pro-Lab, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 18d
Cleared May 29, 1986
MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST
K861835 · Syva Co.
GTH · Antiserum, Fluorescent (direct Test), All Groups, N. Gonorrhoeae · 16d
Cleared May 23, 1986
TOXOPLASMA IGG CLIN-ELISA TEST KIT CAT. NO. 4560
K860773 · Clinical Sciences, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 81d
Cleared May 20, 1986
VISIBLE-HERPES TM TEST SYSTEM
K854712 · Isolab, Inc.
GQO · Antisera, Cf, Herpesvirus Hominis 1,2 · 179d
Cleared May 20, 1986
SENSITITRE AUTO ID PLATE, AP70
K861058 · Gibco Laboratories Life Technologies, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 62d
Cleared May 20, 1986
PENICILLIN-STREPTOMYCIN-FUNGIZONE
K861791 · Flow Laboratories, Inc.
JSK · Supplement, Culture Media · 11d

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All categories 5941 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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75