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
1351–1375 of 5928
Cleared Dec 24, 2008
BD BACTEC Plus Aerobic/F Culture Vials
K083572 · Becton, Dickinson & CO
MDB · System, Blood Culturing · 21d
Cleared Dec 23, 2008
VIDAS RUB IGG
K080766 · bioMerieux, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 280d
Cleared Dec 23, 2008
D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT
K081746 · Diagnostic Hybrids, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 187d
Cleared Dec 23, 2008
D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT
K081928 · Diagnostic Hybrids, Inc.
LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 169d
Cleared Dec 19, 2008
E.COLI/P. AERUGINOSA PNA FISH
K081309 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 224d
Cleared Dec 11, 2008
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K081824 · Becton, Dickinson & CO
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 167d
Cleared Dec 11, 2008
BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
K081825 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 167d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · Roche Diagnostics Corp.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 445d
Cleared Dec 05, 2008
LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV
K082049 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 140d
Cleared Dec 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML
K082913 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 66d
Cleared Nov 21, 2008
DIASORIN LIASON RUBELLA IGG ASSAY
K073390 · DiaSorin, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 354d
Cleared Nov 20, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST
K082538 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 79d
Cleared Nov 18, 2008
LIAISON HSV-1 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-1 IGG
K081685 · DiaSorin, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 154d
Cleared Nov 10, 2008
LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG
K081687 · DiaSorin, Inc.
MYF · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 · 146d
Cleared Nov 03, 2008
LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM
K082050 · DiaSorin, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 108d
Cleared Oct 24, 2008
SENSITITRE VIZION
K081520 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 147d
Cleared Oct 06, 2008
FLUCONAZOLE 25UG BBL SENSI-DISC
K082271 · Becton, Dickinson & CO
JTN · Susceptibility Test Discs, Antimicrobial · 56d
Cleared Oct 06, 2008
BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A
K082661 · Princeton BioMeditech Corp.
GTY · Antigens, All Groups, Streptococcus Spp. · 24d
Cleared Oct 02, 2008
VORICONAZOLE 1UG BBL SENSI-DISC
K082272 · Becton, Dickinson & CO
JTN · Susceptibility Test Discs, Antimicrobial · 52d
Cleared Sep 30, 2008
CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL
K080570 · Centers For Disease Control and Prevention
NXD · Nucleic Acid Amplification, Novel Influenza A Virus, A/h5 (asian Lineage) Rna · 214d
Cleared Sep 29, 2008
XPERT MRSA/SA BLOOD CULTURE ASSAY
K082140 · Cepheid
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 61d
Cleared Sep 24, 2008
XPERT MRSA/SA SSTI ASSAY
K080837 · Cepheid
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 183d
Cleared Sep 12, 2008
YEAST TRAFFIC LIGHT PNA FISH
K080719 · Advandx, Inc.
JXB · Kit, Identification, Yeast · 183d
Cleared Sep 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST CEFOXITIN SCREEN
K081013 · Siemens Healthcare Diagnostics
LRG · Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems · 152d
Cleared Aug 04, 2008
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381 · Focus Diagnostics, Inc.
LJN · Antibody Igm, If, Epstein-barr Virus · 245d

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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