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
5934 Microbiology devices
2901–2925 of 5934
Cleared Jun 13, 1994
PASCO MIC AND MIC/ID PANELS
K935805 · Pasco Laboratories, Inc.
JTT · Susceptibility Test Powders, Antimicrobial · 193d
Cleared May 20, 1994
BACTICARD STREP
K936021 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 154d
Cleared May 18, 1994
FLEXSURE HP
K934863 · Smithkline Diagnostics, Inc.
LYR · Helicobacter Pylori · 218d
Cleared May 17, 1994
READER
K926248 · Alamar Biosciences Laboratory, Inc.
LRH · Instrument For Auto Reader Of Overnight Microorganism Identification System · 519d
Cleared May 17, 1994
PARAKIT
K941110 · Hardy Diagnostics
LKS · Device, Parasite Concentration · 71d
Cleared May 05, 1994
CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY
K935809 · Light Diagnostics
GQH · Antigen, Cf (including Cf Control), Cytomegalovirus · 154d
Cleared Apr 26, 1994
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301 · Gen-Probe, Inc.
LSL · Dna-reagents, Neisseria · 826d
Cleared Apr 26, 1994
CLOSTRIDIUM DIFFICILE TOX-B TEST
K935296 · Techlab, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 174d
Cleared Apr 21, 1994
OT IGG SORBENT
K934324 · Organon Teknika Corp.
DEW · Igg, Antigen, Antiserum, Control · 230d
Cleared Apr 21, 1994
SERIM PYLORITEK REAGENT STRIPS
K936034 · Serim Research Corp.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 127d
Cleared Apr 20, 1994
RIM E.COLI 0157:H7 LATEX TEST
K933457 · Remel Co.
GNA · Antisera, All Types, Escherichia Coli · 280d
Cleared Apr 06, 1994
PACE 2 CHLAMYDIA TRACHOMATIS PROBE CONFIRM ASSAY
K920302 · Gen-Probe, Inc.
LSK · Dna-reagents, Chlamydia · 806d
Cleared Mar 29, 1994
SENSI-CAL AMCO AEPA-1
K935566 · Radiometer America, Inc.
LIE · Reagent/device, Inoculum Calibration · 131d
Cleared Mar 25, 1994
PATHODX CYTOMEGALOVIRUS
K934798 · Diagnostic Products Corp.
LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus · 169d
Cleared Mar 11, 1994
GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
K924715 · Gen-Probe, Inc.
MDK · Dna-probe, Reagents, Streptococcal · 536d
Cleared Mar 07, 1994
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · Pb Diagnostic Systems, Inc.
MJX · Kit, Serological, Positive Control · 194d
Cleared Mar 01, 1994
PIPERACILLIN/TOZOBACTAM, 100/10 MCG SENSI-DISC
K940359 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 25d
Cleared Feb 25, 1994
BACTICARD CANDIDA
K935124 · Remel Co.
JXB · Kit, Identification, Yeast · 120d
Cleared Feb 23, 1994
BACTICARD E. COLI
K934986 · Remel Co.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 127d
Cleared Feb 22, 1994
CULTURESWAB TRANSPORT SYSTEM
K934894 · Difco Laboratories, Inc.
JTW · System, Transport, Aerobic · 140d
Cleared Feb 17, 1994
CRYPTO-LEX SYSTEM
K930418 · Trinity Laboratories, Inc.
GMD · Antisera, Latex Agglutination, Cryptococcus Neoformans · 387d
Cleared Feb 17, 1994
STOOL TRANSPORT/PROCESSOR
K933370 · Sage Products, Inc.
LKS · Device, Parasite Concentration · 223d
Cleared Feb 17, 1994
PARASAFE(R) FIXATIVE
K935316 · Scientific Device Laboratory, Inc.
LKS · Device, Parasite Concentration · 107d
Cleared Feb 09, 1994
BACT/ALERT 120
K934593 · Organon Teknika Corp.
MDB · System, Blood Culturing · 138d
Cleared Feb 07, 1994
BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT
K933939 · Organon Teknika Corp.
GIM · Tubes, Vacuum Sample, With Anticoagulant · 179d

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All categories 5934 JWY Manual Antimicrobial Susceptibility Test Systems 408 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 OCC Respiratory Virus Panel Nucleic Acid Assay System 75 LYR Helicobacter Pylori 75