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
4276–4300 of 5941
Cleared Feb 20, 1986
AUSTIN ENTERIC SYSTEM
K860194 · Austin Biological Laboratories
JSE · Culture Media, Multiple Biochemical Test · 29d
Cleared Feb 20, 1986
PRECEPT TRIMETHOPRIM/SULFAMETHOXAZOLE
K860195 · Austin Biological Laboratories
JWY · Manual Antimicrobial Susceptibility Test Systems · 29d
Cleared Feb 06, 1986
RAPID GLUTAMIC ACID DECARBOXYLASE (GDC) MICROTUBE
K860301 · Carr-Scarborough Microbiologicals, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 9d
Cleared Feb 05, 1986
PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN)
K854577 · Austin Biological Laboratories
JWY · Manual Antimicrobial Susceptibility Test Systems · 105d
Cleared Feb 05, 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · Clinical Sciences, Inc.
GQI · Antiserum, Cf, Cytomegalovirus · 76d
Cleared Feb 05, 1986
PYR DISCS
K860302 · Carr-Scarborough Microbiologicals, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 8d
Cleared Feb 04, 1986
ORTHO HSV ANTIGEN ELISA TEST
K854488 · Ortho Diagnostic Systems, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 88d
Cleared Feb 04, 1986
CYTOMEGELISA M TEST KIT
K854839 · Whittaker Bioproducts, Inc.
LKQ · Antibody Igm,if, Cytomegalovirus Virus · 62d
Cleared Feb 04, 1986
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
K854851 · Wellcome Diagnostics
GTJ · Antisera, All Groups, N. Meningitidis · 61d
Cleared Feb 04, 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
K854852 · Wellcome Diagnostics
GTJ · Antisera, All Groups, N. Meningitidis · 61d
Cleared Jan 28, 1986
MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES
K854615 · Serono Diagnostics, Inc.
LKI · Antisera, Fluorescent, Chlamydia Spp. · 71d
Cleared Jan 24, 1986
CEFACLOR 30 MCG SENSITIVITY DISCS
K855206 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 25d
Cleared Jan 21, 1986
HSV2 - IGG ELISA-KIT
K852781 · Clinical Sciences, Inc.
GQO · Antisera, Cf, Herpesvirus Hominis 1,2 · 204d
Cleared Jan 21, 1986
HSVI - IGG ELISA-KIT
K852782 · Clinical Sciences, Inc.
GQO · Antisera, Cf, Herpesvirus Hominis 1,2 · 204d
Cleared Jan 21, 1986
PASCO RESISTANT 5 PANEL
K853862 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 126d
Cleared Jan 21, 1986
ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS
K854129 · Orion Diagnostica, Inc.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 104d
Cleared Jan 13, 1986
CEFACLOR SENSI-DISC
K855135 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 21d
Cleared Jan 07, 1986
DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8
K855110 · Gibco Laboratories Life Technologies, Inc.
JSI · Culture Media, Selective And Differential · 15d
Cleared Jan 03, 1986
IMAGEN RESPIRATORY SYNCYTIAL VIRUS TEST
K854081 · Boots-Celltech Diagnostics, Inc.
GQG · Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus · 88d
Cleared Jan 03, 1986
IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST
K854447 · American Micro Scan
GTZ · Antisera, All Groups, Streptococcus Spp. · 59d
Cleared Jan 03, 1986
BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU
K854986 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JSM · Culture Media, Non-propagating Transport · 22d
Cleared Jan 01, 1986
TANDEM ICON RUBELLA IGG IMMUNOENZYMETRIC ASSAY KIT
K853069 · Hybritech, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 163d
Cleared Dec 27, 1985
IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
K854490 · American Micro Scan
GRP · Antisera, All Types, H. Influenza · 45d
Cleared Dec 23, 1985
TRANSPORT CULTURE MEDIA
K854715 · Hillcrest Biologicals
JSM · Culture Media, Non-propagating Transport · 31d
Cleared Dec 06, 1985
ORTHO CHLAMYDIA DIRECT DETECTION (FA) TEST
K853738 · Ortho Diagnostic Systems, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 91d

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