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
1276–1300 of 5928
Cleared Mar 29, 2010
BIOPLEX 2200 MMRV IGG
K091616 · Bio-Rad Laboratories
OPL · Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus · 299d
Cleared Mar 29, 2010
TELAVANCIN 30 UG, BBL SENSI-DISC
K100722 · Becton, Dickinson and Company
JTN · Susceptibility Test Discs, Antimicrobial · 14d
Cleared Mar 12, 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · Roche Diagnostics
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 220d
Cleared Mar 12, 2010
C. ALBICANS/C. GLABRATA PNA FISH
K092784 · Advandx, Inc.
NZS · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast · 183d
Cleared Mar 02, 2010
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 326d
Cleared Feb 24, 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
K091766 · Binax, Inc.
MYI · System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies · 252d
Cleared Feb 23, 2010
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · Sa Scientific, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 28d
Cleared Feb 17, 2010
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 63d
Cleared Jan 26, 2010
MICROSCAN MICROSTREP PLUS, MODEL B1027-201
K091949 · Siemens Healthcare Diagnostics
LTT · Panels, Test, Susceptibility, Antimicrobial · 209d
Cleared Jan 19, 2010
C. ALBICANS PNA FISH
K092655 · Advandx, Inc.
NZS · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast · 144d
Cleared Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
K093807 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 28d
Cleared Dec 23, 2009
D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT
K093415 · Diagnostic Hybrids, Inc.
GQS · Antigens, Cf (including Cf Control), Parainfluenza Virus 1-4 · 51d
Cleared Dec 17, 2009
Xpert VanA Assay
K092953 · Cepheid
NIJ · System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species · 84d
Cleared Dec 16, 2009
BINAXNOX STAPHYLOCOCCUS AUREUS TEST
K090964 · Binax, Inc.
JWX · Kit, Screening, Staphylococcus Aureus · 254d
Cleared Dec 16, 2009
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
K091361 · Siemens Healthcare Diagnostics
LIP · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum · 222d
Cleared Dec 16, 2009
E.COLI/P. AERUGINOSA PNA FISH
K092236 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 146d
Cleared Dec 04, 2009
D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT
K093233 · Diagnostic Hybrids, Inc.
OMG · Antisera, Fluorescent, Human Metapneumovirus · 51d
Cleared Nov 23, 2009
S. AUREUS/CNS PNA FISH, MODEL KT005
K092166 · Advandx, Inc.
NXX · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus · 125d
Cleared Nov 17, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
K093337 · Nanosphere, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 22d
Cleared Nov 13, 2009
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
K091724 · Becton, Dickinson & CO
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 155d
Cleared Nov 13, 2009
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K091730 · Becton, Dickinson & CO
LSL · Dna-reagents, Neisseria · 155d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888 · Roche Diagnostics Corp.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 50d
Cleared Nov 09, 2009
DENSICHECK PLUS
K093224 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 26d
Cleared Oct 30, 2009
ELECSYS RUBELLA IGGA CALCHECK 5
K092585 · Roche Diagnostics
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 67d
Cleared Oct 29, 2009
MONOLISA ANTI-HAV IGM EIA
K092353 · Bio-Rad Laboratories, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 86d

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

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