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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
2026–2050 of 7095
Cleared Aug 29, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV CONTROLS
K012561 · Ortho-Clinical Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 21d
Cleared Aug 22, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · Dade Behring, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 191d
Cleared Aug 20, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR TOXOPLASMA IGM ASSAY
K010755 · Bayer Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 160d
Cleared Aug 15, 2001
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
K011803 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 65d
Cleared Jul 31, 2001
COPAN VIRAL TRANSYSTEM
K001780 · Copan Diagnostics, Inc.
JSM · Culture Media, Non-propagating Transport · 413d
Cleared Jul 27, 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 191d
Cleared Jul 09, 2001
VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI
K011668 · Oridion Medical 1987 , Ltd.
MSQ · Test, Urea (breath Or Blood) · 53d
Cleared Jul 05, 2001
BAYER DIAGNOSTICS ADVIA CENTAUR RUBELLA IGM ASSAY
K010668 · Bayer Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 121d
Cleared Jun 13, 2001
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479
K003259 · Beckman Coulter, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 238d
Cleared Jun 13, 2001
VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS
K011250 · Ortho-Clinical Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 50d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 37d
Cleared Jun 11, 2001
IMMUNOWELL EA (D) IGG TEST
K010301 · Genbio
LSE · Epstein-barr Virus, Other · 130d
Cleared Jun 06, 2001
BACTEC MGIT 960 SIR KITS
K003062 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MJA · Susceptibility Test Powders, Antimycobacterial · 247d
Cleared May 31, 2001
NAT - NUCLEIC ACID TRANSPORT
K003761 · Medical Packaging Corp.
LIO · Device, Specimen Collection · 176d
Cleared May 24, 2001
VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION
K010858 · Id Biomedical Corp.
MYI · System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies · 63d
Cleared May 21, 2001
GEN-PROBE APTIMA COMBO 2 ASSAY
K003395 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 201d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 11d
Cleared May 10, 2001
IMMUNETICS C6 LYME ELISA KIT
K003754 · Immunetics, Inc.
LSR · Reagent, Borrelia Serological Reagent · 156d
Cleared May 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · Quidel Corp.
GTY · Antigens, All Groups, Streptococcus Spp. · 27d
Cleared May 07, 2001
ACON STREP A RAPID TEST STRIP
K010582 · Acon Laboratories Co.
GTY · Antigens, All Groups, Streptococcus Spp. · 69d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 16d
Cleared Apr 24, 2001
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 60d
Cleared Apr 24, 2001
LINEZOLID ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010537 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 60d
Cleared Apr 24, 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · Pasco Laboratories, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 62d
Cleared Apr 23, 2001
PASCO MIC AND MIC/ID PANELS
K010508 · Pasco Laboratories, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 61d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87