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
1176–1200 of 5928
Cleared Jan 20, 2012
TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS
K112343 · Siemens Healthcare Diagnostics, Inc.
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 158d
Not Cleared Jan 20, 2012
STRATIFY JCV(TM) ANTIBODY
DEN120008 · Focus Diagnostics, Inc.
OYP · Anti-jcv Antibody Detection Assay · 14d
Cleared Dec 22, 2011
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K112172 · Quidel Corp.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 147d
Cleared Dec 16, 2011
IMMUNOCARD C. DIFFICILE GDH
K112048 · Meridian Bioscience, Inc.
MCB · Antigen, C. Difficile · 151d
Cleared Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
K112424 · Nanosphere, Inc.
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 115d
Cleared Dec 15, 2011
QUIDEL MOLECULAR HMPV ASSAY
K112490 · Quidel Corp.
OEM · Human Metapneumovirus (hmpv) Rna Assay System · 108d
Cleared Dec 05, 2011
ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
K112125 · Meridian Bioscience, Inc.
NJR · Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test · 133d
Cleared Nov 30, 2011
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE
K110106 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 321d
Cleared Nov 16, 2011
VIZION
K112276 · Trek Diagnostic Systems
JWY · Manual Antimicrobial Susceptibility Test Systems · 99d
Cleared Nov 09, 2011
ASIMANAGER - AT
K111356 · Arlington Scientific, Inc.
JQT · Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica · 177d
Cleared Nov 08, 2011
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES
K111615 · Trek Diagnostic Systems
JWY · Manual Antimicrobial Susceptibility Test Systems · 151d
Cleared Oct 28, 2011
BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
K112277 · Becton, Dickinson and Company
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 80d
Cleared Oct 26, 2011
VITEK 2 STREPTOCOCCUS PENICILLIN
K112000 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 105d
Cleared Oct 24, 2011
SOFIA ANALYZER AND INFLUENZA A+B FIA
K112177 · Quidel Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 88d
Cleared Oct 21, 2011
VRESELECT CULTURE MEDIUM
K103684 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 308d
Cleared Oct 18, 2011
VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE
K111909 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 105d
Cleared Oct 18, 2011
CEFTAROLINE 30 MICROGRAMS, BBL(TM) SENSI-DISC(TM)
K112586 · Becton, Dickinson and Company (BD)
JTN · Susceptibility Test Discs, Antimicrobial · 42d
Cleared Oct 14, 2011
VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE
K103752 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 295d
Cleared Oct 03, 2011
VITEK 2 STREPTOCOCCUS LEVOFLOXACIN
K112228 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 61d
Cleared Sep 27, 2011
ISOAMP HSV ASSAY
K111951 · Biohelix Corporation
OQO · Herpes Simplex Virus Nucleic Acid Amplification Assay · 81d
Cleared Sep 27, 2011
VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN
K112129 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 63d
Cleared Sep 22, 2011
SENSITITRE OPTIREAD
K110583 · Trek Diagnostic Systems, Ltd.
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 205d
Cleared Sep 15, 2011
VITEK 2 STRPTOCOCCUS AMPICILLIN
K112075 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 57d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A&B DETECTION KIT
K111775 · U.S. Army Medical Material Development Acitvity
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 82d
Cleared Sep 13, 2011
JBAIDS INFLUENZA A SUBTYPING KIT
K111778 · U.S Army Medical Materiel Development Activity
OQW · 2009 H1n1 Influenza Virus (swine Origin), Nucleic Acid Or Antigen, Detection And Identification · 82d

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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