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
5928 Microbiology devices
1901–1925 of 5928
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
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 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
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 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
C. DIFFICILE TOX A/B II
K003306 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 33d
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139 · Ab Biodisk
LTX · Discs, Elution · 114d
Cleared Nov 02, 2000
HARDYDISK CLINDAMYCIN, 2MCG
K002662 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 69d
Cleared Nov 02, 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS CONTROLS
K003112 · Ortho-Clinical Diagnostics, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 29d
Cleared Oct 26, 2000
HARDY DISK CEFTIZOXIME, 30MCG
K002367 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 84d
Cleared Oct 26, 2000
HARDYDISK GENTAMICIN, 120MCG
K002369 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 84d

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All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 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 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74