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
3126–3150 of 5934
Cleared Feb 27, 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · Behring Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 192d
Cleared Feb 21, 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851 · Quidel Corp.
LYR · Helicobacter Pylori · 56d
Cleared Feb 14, 1992
DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440
K912666 · Dako Corp.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 241d
Cleared Feb 14, 1992
CMV IGG ELISA TEST
K915892 · Gull Laboratories, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 52d
Cleared Feb 06, 1992
CLARITHROMYCIN 15MCG SENSI DISC
K920131 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 27d
Cleared Jan 30, 1992
STREP A OIA
K915758 · Biosearch Medical Products, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 38d
Cleared Jan 23, 1992
ELISA TOXO IGM
K914852 · Sclavo, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 87d
Cleared Dec 30, 1991
IMMUNOWELL LYME (P39 RECOMBINANT) TEST
K911599 · General Biometrics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 265d
Cleared Dec 27, 1991
ELISA RUBELLA IGM
K914420 · Sclavo, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 85d
Cleared Dec 20, 1991
IMMUNOWELL BORRELIA (LYME)TEST
K911590 · General Biometrics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 255d
Cleared Dec 18, 1991
TOXOPLASMA IGM ELISA TEST SYSTEM
K913787 · Zeus Scientific, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 117d
Cleared Dec 17, 1991
INFLUENZA MAB TEST/INFLUENZA A TEST
K913351 · Gull Laboratories, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 144d
Cleared Dec 13, 1991
INFLUENZA MAB TEST/INFLUENZA B TEST
K913214 · Gull Laboratories, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 147d
Cleared Dec 09, 1991
RSV-MAB TEST
K912842 · Gull Laboratories, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 166d
Cleared Dec 04, 1991
CMV-EA MAB TEST
K912592 · Gull Laboratories, Inc.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 177d
Cleared Nov 29, 1991
ABBOTT IMX TOXO IGM POSITIVE CONTROL
K913106 · Abbott Laboratories
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 140d
Cleared Nov 19, 1991
WALKAWAY TM 40
K911400 · Baxter Healthcare Corp
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 235d
Cleared Nov 19, 1991
MARLOW SUCTION/IRRIGATION PROBES
K914872 · Marlo Surgical Technology
GSJ · Antiserum, Fluorescent, Francisella Tularensis · 21d
Cleared Nov 05, 1991
LYME-CHECK(TM) TEST KIT
K896378 · Diagnostic Technology, Inc.
LSR · Reagent, Borrelia Serological Reagent · 729d
Cleared Oct 31, 1991
OIA STREP A
K912889 · Biosearch Medical Products, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 122d
Cleared Oct 28, 1991
SCEPTOR IDENTIFICATION SYSTEM
K912897 · Bd Becton Dickinson Vacutainer Systems Preanalytic
LQM · Gram Negative Identification Panel · 119d
Cleared Oct 21, 1991
LYME STAT M TEST KIT
K904652 · Whittaker Bioproducts, Inc.
LSR · Reagent, Borrelia Serological Reagent · 371d
Cleared Oct 21, 1991
PYLORISET
K904655 · Orion Diagnostica, Inc.
LYR · Helicobacter Pylori · 374d
Cleared Oct 16, 1991
FIAX LYME M TEST KIT
K904893 · Whittaker Bioproducts, Inc.
LSR · Reagent, Borrelia Serological Reagent · 351d
Cleared Oct 11, 1991
VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY
K905211 · Vitek Systems, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 325d

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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