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
2901–2925 of 7095
Cleared Nov 20, 1995
MRC-5 CELL CULTURE VIAL
K952727 · Viratest Intl., Inc.
KIR · Cells, Animal And Human, Cultured · 159d
Cleared Nov 20, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII
K952818 · Pyramid Biological Corp.
GMM · Antigens, Iha, Toxoplasma Gondii · 153d
Cleared Nov 20, 1995
GIBSON ID A.E. TEST
K953247 · Gibson Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 132d
Cleared Nov 16, 1995
CMV IGG HUMAN SERUM CONTROLS
K951800 · Pyramid Biological Corp.
GQI · Antiserum, Cf, Cytomegalovirus · 212d
Cleared Nov 16, 1995
ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
K952254 · Pyramid Biological Corp.
GQI · Antiserum, Cf, Cytomegalovirus · 185d
Cleared Nov 16, 1995
MID-STREAM COLLECTION SET-STERILE
K953929 · Trinity Laboratories, Inc.
LIO · Device, Specimen Collection · 87d
Cleared Nov 14, 1995
PREMIER EHEC
K953362 · Meridian Diagnostics, Inc.
GNA · Antisera, All Types, Escherichia Coli · 120d
Cleared Nov 01, 1995
VIROTROL IV
K954298 · Blackhawk Biosystems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 48d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP A ANTIGEN
K953841 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA H C ANTIGEN
K953842 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP F ANTIGEN
K953843 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA VI ANTIGEN
K953844 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP C ANTIGEN
K953846 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 26, 1995
SAS SALMONELLA O GROUP B ANTIGEN
K953848 · Sa Scientific, Inc.
GNC · Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. · 71d
Cleared Oct 20, 1995
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ · Antisera, All Groups, Streptococcus Spp. · 200d
Cleared Oct 20, 1995
OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT
K953437 · Olympus America, Inc.
GTQ · Antistreptolysin - Titer/streptolysin O Reagent · 91d
Cleared Oct 20, 1995
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
K954257 · Quidel Corp.
GTZ · Antisera, All Groups, Streptococcus Spp. · 85d
Cleared Oct 17, 1995
MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEM
K950073 · Shared Systems, Inc.
GSA · Antisera, All Mycoplasma Spp. · 281d
Cleared Oct 17, 1995
MEDTEC AUTOBLOT 2000
K951753 · Medtec, Inc.
JQW · Station, Pipetting And Diluting, For Clinical Use · 183d
Cleared Oct 16, 1995
CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST
K951754 · Hardy Diagnostics
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 182d
Cleared Oct 07, 1995
CHLAMYDIA OIA
K951010 · Biostar, Inc.
LJC · Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) · 215d
Cleared Oct 07, 1995
JUSTONE
K951240 · Radiometer America, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 222d
Cleared Oct 07, 1995
HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
K951241 · Radiometer America, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 222d
Cleared Oct 07, 1995
FOX FASTIDIOUS TEST PANELS
K953422 · Micro-Media Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 92d
Cleared Oct 06, 1995
TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
K953284 · Trend Scientific, Inc.
MHI · Giardia Spp. · 85d

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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