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
1451–1475 of 7095
Cleared Jul 10, 2008
ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT
K080739 · Abbott Molecular, Inc.
MKZ · Dna Probe, Nucleic Acid Amplification, Chlamydia · 115d
Cleared Jun 26, 2008
PLATELIA LYME IGM
K081362 · Bio-Rad
LSR · Reagent, Borrelia Serological Reagent · 42d
Cleared Jun 25, 2008
XTAG RESPIRATORY VIRAL PANEL
K081483 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 28d
Cleared Jun 23, 2008
NUCLISENS EASYQ ENTEROVIRUS SYSTEM
K063261 · bioMerieux, Inc.
OAI · Assay, Enterovirus Nucleic Acid · 602d
Cleared Jun 13, 2008
D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
K081164 · Diagnostic Hybrids, Inc.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 50d
Cleared Jun 13, 2008
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 45d
Cleared Jun 11, 2008
VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY
K080931 · bioMerieux, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 70d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · Roche Diagnostics Corp.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 179d
Cleared May 30, 2008
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM
K072178 · Zeus Scientific, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 298d
Cleared May 23, 2008
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC
K080869 · Beckman Coulter, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 53d
Cleared May 12, 2008
DORIPENEM 10UG BBL SENSI-DISC
K080998 · Becton, Dickinson & CO
JTN · Susceptibility Test Discs, Antimicrobial · 35d
Cleared May 08, 2008
PLATELIA LYME IGG ASSAY
K080012 · Bio-Rad
LSR · Reagent, Borrelia Serological Reagent · 126d
Cleared May 02, 2008
MODIFICATION TO PROFLU+ ASSAY
K081030 · Prodesse, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 21d
Cleared Apr 30, 2008
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE
K080201 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 93d
Cleared Apr 16, 2008
RAMP INFLUENZA A/B ASSAY
K071591 · Response Biomedical Corp.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 310d
Cleared Mar 31, 2008
B R A H M S PCT SENSITIVE KRYPTOR TEST SYSTEM
K070310 · Brahms Aktiengesellschaft
NTM · Antigen, Inflammatory Response Marker, Sepsis · 424d
Cleared Mar 20, 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d
Cleared Mar 13, 2008
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d
Cleared Mar 05, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS
K073589 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 76d
Cleared Feb 28, 2008
SPECTRA MRSA
K073027 · Thermo Fisher Scientific
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 125d
Cleared Feb 28, 2008
VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM
K080107 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 44d
Cleared Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · Hardy Diagnostics
JTN · Susceptibility Test Discs, Antimicrobial · 26d
Cleared Jan 23, 2008
VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE
K073406 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 50d
Cleared Jan 22, 2008
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 48d
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 39d

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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