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

7095
Total
7032
Cleared
150d
Avg (2y)
1976
Since
7095 Microbiology devices
1351–1375 of 7095
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 Nov 02, 2009
ETEST VORICONAZOLE 0.002-32 UG/ML
K082534 · Ab Biomerieux
NGZ · Susceptibility Test Plate, Antifungal · 426d
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
Cleared Oct 29, 2009
MONOLISA ANTI-HAV EIA
K092355 · Bio-Rad Laboratories, Inc.
LOL · Hepatitis A Test (antibody And Igm Antibody) · 86d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · Siemens Healthcare Diagnostics
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 30d
Cleared Oct 21, 2009
D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KIT
K092882 · Diagnostic Hybrids, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 33d
Cleared Oct 21, 2009
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
K092957 · Nanosphere, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 26d
Cleared Oct 21, 2009
MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
K093116 · Response Biomedical Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 19d
Cleared Oct 09, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
K092566 · Nanosphere, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 50d
Cleared Sep 25, 2009
OSOM INFLUENZA A&B TEST , MODEL PN190
K092633 · Genzyme Corporation
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 29d
Cleared Sep 15, 2009
QUICKVUE INFLUENZA A+B TEST
K092698 · Quidel Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 13d
Cleared Sep 11, 2009
DENSICHEK PLUS
K083536 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 287d
Cleared Sep 11, 2009
D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT
K091171 · Diagnostic Hybrids, Inc.
OMG · Antisera, Fluorescent, Human Metapneumovirus · 142d
Cleared Sep 11, 2009
TRU FLU, MODEL 751230
K092553 · Meridian Bioscience, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 22d
Cleared Sep 04, 2009
CLEARVIEW ADVANCED STREP A , MODEL 737-430
K091489 · Binax, Inc.
GTY · Antigens, All Groups, Streptococcus Spp. · 107d
Cleared Sep 01, 2009
BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010
K083744 · Binax, Inc.
MJZ · Kit, Direct Antigen, Positive Control · 259d
Cleared Sep 01, 2009
EK/P. AERUGINOSA PNA FISH
K092393 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 27d
Cleared Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753 · Diagnostic Hybrids, Inc.
GQL · Antisera, Fluorescent, Herpesvirus Hominis 1,2 · 73d
Cleared Aug 28, 2009
MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K092300 · Diagnostic Hybrids, Inc.
GNW · Antisera, Cf, Influenza Virus A, B, C · 30d
Cleared Aug 26, 2009
XPECT FLU A & B
K092423 · Thermo Fisher Scientific
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 19d
Cleared Aug 20, 2009
MODIFICATION TO PROFLU+ ASSAY
K092500 · Prodesse, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 6d

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All categories 7095 JWY Manual Antimicrobial Susceptibility Test Systems 441 JTN Susceptibility Test Discs, Antimicrobial 323 JSJ Culture Media, Selective And Non-differential 299 LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation 291 JSI Culture Media, Selective And Differential 267 JTO Discs, Strips And Reagents, Microorganism Differentiation 239 JSG Culture Media, Non-selective And Non-differential 198 JSH Culture Media, Non-selective And Differential 142 LSR Reagent, Borrelia Serological Reagent 112 JSM Culture Media, Non-propagating Transport 110 LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii 104 GTZ Antisera, All Groups, Streptococcus Spp. 99 LFX Enzyme Linked Immunoabsorbent Assay, Rubella 92 LYR Helicobacter Pylori 91 JSF Culture Media, Single Biochemical Test 87