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
1301–1325 of 5928
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 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 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 18, 2009
S. AUREUS PNA FISH
K091827 · Advandx, Inc.
NXX · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Staphylococcus Aureus · 60d
Cleared Aug 14, 2009
VITEK 2 GRAM NEGATIVE MEROPENEM
K091899 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 50d
Cleared Aug 12, 2009
MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
K092223 · Binax, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 20d
Cleared Jul 24, 2009
AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT
K083074 · Advandx, Inc.
OAH · Fish (fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis · 282d
Cleared Jul 23, 2009
SAS INFLUENZA A & B TEST
K080380 · Sa Scientific, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 526d
Cleared Jul 22, 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS, MODEL B1017
K091264 · Siemens Healthcare Diagnostics
LTT · Panels, Test, Susceptibility, Antimicrobial · 83d
Cleared Jul 17, 2009
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · bioMerieux, Inc.
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 98d
Cleared Jul 09, 2009
XPERT C. DIFFICILE
K091109 · Cepheid
LLH · Reagents, Clostridium Difficile Toxin · 84d
Cleared Jul 01, 2009
PLATELIA TOXO IGM KIT MODEL 26211
K090847 · Bio-Rad Laboratories
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 93d
Cleared Jun 25, 2009
E. COLI PNA FISH
K082068 · Advandx, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 338d

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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