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
2051–2075 of 7095
Cleared Apr 18, 2001
MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6
K010878 · Diagnostic Products Corp.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 30d
Cleared Apr 13, 2001
ADVIA CENTAUR RUBELLA IGG ASSAY
K003412 · Bayer Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 162d
Cleared Apr 09, 2001
ETEST MEROPENEM
K010363 · Ab Biodisk
JWY · Manual Antimicrobial Susceptibility Test Systems · 61d
Cleared Mar 30, 2001
ELISA TEST, SEROLOGY
K003794 · Micro Detect, Inc.
LYR · Helicobacter Pylori · 112d
Cleared Mar 15, 2001
MODIFICATION TO BINAX NOW STREPTOCOCCUS PNEUMONIAE URINARY ANTIGEN TEST
K010523 · Binax, Inc.
GTZ · Antisera, All Groups, Streptococcus Spp. · 21d
Cleared Mar 06, 2001
SUSCEPTIBILITY TEST PANEL
K004045 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 67d
Cleared Feb 27, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 75d
Cleared Feb 23, 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003834 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 73d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 56d
Cleared Jan 19, 2001
BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
K000884 · Becton Dickinson Biosciences
NDZ · Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis · 305d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 63d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 61d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 57d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 57d
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 43d
Cleared Jan 09, 2001
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K003619 · Dade Microscan, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 48d
Cleared Dec 13, 2000
HARDY DISK, CEFPODOXINE, 10MCG
K003532 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 27d
Cleared Nov 29, 2000
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · Trinity Biotech, Plc
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 197d
Cleared Nov 28, 2000
DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM
K002262 · Diamedix Corp.
LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 126d
Cleared Nov 22, 2000
PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
K002024 · Panbio, Inc.
GRY · Antigens, All, Leptospira Spp. · 142d
Cleared Nov 22, 2000
C. DIFFICILE TOX A/B II
K003306 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 33d
Cleared Nov 13, 2000
PP-CAP EIA FOR THE DETECTION OF IGA ANTIBODIES TO H. PYLORI
K001177 · Enteric Products, Inc.
LYR · Helicobacter Pylori · 216d
Cleared Nov 13, 2000
MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
K002023 · Medmira Laboratories, Inc.
LYR · Helicobacter Pylori · 133d
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139 · Ab Biodisk
LTX · Discs, Elution · 114d
Cleared Nov 07, 2000
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
K003204 · Intracel Corp.
GNW · Antisera, Cf, Influenza Virus A, B, C · 25d

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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