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
1201–1225 of 5928
Cleared Sep 01, 2011
XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)
K112199 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 31d
Cleared Aug 26, 2011
AUTOREADER 2
K103532 · Trek Diagnostic Systems
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 268d
Cleared Aug 25, 2011
VENTANA ANTI-HELICOBACTER PYLORI (SP48) RABBIT MONOCLONAL PRIMARY ANTIBODY
K101234 · Ventana Medical Systems, Inc.
OWF · Immunohistochemical Assay, Helicobacter Pylori · 479d
Cleared Aug 23, 2011
BIOPLEX 2200 MMRV IGG IT ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, BIOPLEX 2200 MMRV IGG CALIBRATOR SET, AND BIOPL
K111072 · Bio-Rad Laboratories
OPL · Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus · 127d
Cleared Aug 23, 2011
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL
K111507 · Centers For Disease Control and Prevention
OQW · 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification · 83d
Cleared Aug 18, 2011
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K103673 · Techlab Inc., Corporate Research Center
MHI · Giardia Spp. · 245d
Cleared Aug 18, 2011
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
K111429 · Trek Diagnostic Systems, Ltd.
JWY · Manual Antimicrobial Susceptibility Test Systems · 87d
Cleared Aug 12, 2011
VITEK 2 AST-ST LINEZOLID
K111599 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 65d
Cleared Aug 04, 2011
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
K111387 · Iquum, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 79d
Cleared Aug 04, 2011
MICROSCAN(R) MICROSTREP PLUS(R)
K111677 · Siemens Healthcare Diagnostics, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 50d
Cleared Aug 03, 2011
MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT
K111527 · Eragen Biosciences, Inc.
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 63d
Cleared Jul 20, 2011
CRAG LATERAL FLOW ASSAY (CRAG LFA)
K102286 · Immuno-Mycologics, Inc.
GMD · Antisera, Latex Agglutination, Cryptococcus Neoformans · 342d
Cleared Jul 20, 2011
MICROSCAN (R) MICROSTREP PLUS (R) PANELS
K111205 · Siemens Healthcare Diagnostics, Inc.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 82d
Cleared Jul 19, 2011
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
K101407 · Immuno-Mycologics, Inc.
MIZ · Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum · 426d
Cleared Jul 01, 2011
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
K103776 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 186d
Cleared Jun 27, 2011
PROFLU+ ASSAY
K110968 · Gen-Probe Prodesse, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 82d
Cleared Jun 22, 2011
THE SENSITITRE AIM
K103456 · Trek Diagnostic Systems
LIE · Reagent/device, Inoculum Calibration · 210d
Cleared Jun 22, 2011
MICROSCAN MICROSTEP
K111394 · Siemens Healthcare Diagnostics, Inc.
LTT · Panels, Test, Susceptibility, Antimicrobial · 35d
Cleared May 20, 2011
NUCLISENS EASYQ MRSA
K102740 · bioMerieux, Inc.
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 240d
Cleared May 20, 2011
ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
K103603 · Zeus Scientific, Inc.
MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 · 163d
Cleared May 18, 2011
VIDAS TOXO IGG AVIDITY
K101946 · bioMerieux, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 310d
Cleared May 17, 2011
RPS ADENO DETECTOR PLUS
K110722 · Rapid Pathogen Screening, Inc.
GOD · Antigens, Cf (including Cf Control), Adenovirus 1-33 · 63d
Cleared May 16, 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
K102535 · Biomerieux S.A.
JWY · Manual Antimicrobial Susceptibility Test Systems · 255d
Cleared May 04, 2011
ADVIA CENTAUR TOXOPLASMA IGG (TOXO G)
K102681 · Siemens Healthcare Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 229d
Cleared May 04, 2011
HARDYCHROM MRSA
K102922 · Hardy Diagnostics
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 215d

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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