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
1876–1900 of 5928
Cleared Nov 26, 2001
BACTI-SWAB DRY
K013711 · Remel Co.
LIO · Device, Specimen Collection · 19d
Cleared Nov 20, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · Trek Diagnostic Systems, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 40d
Cleared Nov 07, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · Trek Diagnostic Systems, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 43d
Cleared Nov 02, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012921 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Oct 30, 2001
HEAMOPHILUS/STREPTOCOCCUS PNEUMONIAE
K012895 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Oct 09, 2001
MODIFICATION TO SENSITITRE YEASTONE MIC SUSCEPTIBILITY TEST
K991810 · Trek Diagnostic Systems, Inc.
NGZ · Susceptibility Test Plate, Antifungal · 866d
Cleared Sep 18, 2001
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 55d
Cleared Sep 12, 2001
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012565 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 34d
Cleared Aug 29, 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K012151 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 50d
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 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 06, 2001
BACTEC MGIT 960 SIR KITS
K003062 · Bd Becton Dickinson Vacutainer Systems Preanalytic
MJA · Susceptibility Test Powders, Antimycobacterial · 247d
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 08, 2001
QUICKVUE DIPSTICK STREP A
K011097 · Quidel Corp.
GTY · Antigens, All Groups, Streptococcus Spp. · 27d
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

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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