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
150d
Avg (2y)
1976
Since
5941 Microbiology devices
4051–4075 of 5941
Cleared Mar 20, 1987
NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
K870117 · Pro-Lab, Inc.
JSX · Kit, Identification, Neisseria Gonorrhoeae · 67d
Cleared Mar 19, 1987
CANDIDATE(R) SUPER
K863499 · Mercia Diagnostics , Ltd.
LRF · Candida Spp., Direct Antigen, Id · 191d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 102d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK
K864848 · Organon Teknika Corp.
JTN · Susceptibility Test Discs, Antimicrobial · 97d
Cleared Mar 17, 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 48d
Cleared Mar 17, 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · Organon Teknika Corp.
JTN · Susceptibility Test Discs, Antimicrobial · 14d
Cleared Mar 16, 1987
(MERIFLUOR)TM-CRYPTOSPORIDIUM
K870171 · Meridian Diagnostics, Inc.
· 61d
Cleared Mar 12, 1987
RICKETTSIAL IGG AND IGM IFA KIT
K864110 · Hillcrest Biologicals
GPN · Antiserum, Typhus Fever · 142d
Cleared Mar 12, 1987
MODIFIED IMAGEN(TM) CHLAMYDIA TEST
K864539 · Boots-Celltech Diagnostics, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 113d
Cleared Mar 10, 1987
DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST
K870155 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GTZ · Antisera, All Groups, Streptococcus Spp. · 56d
Cleared Mar 05, 1987
AZTREONAM 30 MCG SENSITIVITY DISKS
K870347 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 36d
Cleared Feb 26, 1987
ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL
K864752 · Abbott Laboratories
GTY · Antigens, All Groups, Streptococcus Spp. · 83d
Cleared Feb 26, 1987
SPOTTEST PYR REAGENT
K870449 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 23d
Cleared Feb 25, 1987
MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST
K864888 · Syva Co.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 75d
Cleared Feb 20, 1987
API UNISCEPT (TM) KB
K864891 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 67d
Cleared Feb 20, 1987
ACCUPOINT TOXO
K865068 · Syva Co.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 53d
Cleared Feb 19, 1987
MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT
K864565 · Serono Diagnostics, Inc.
GQH · Antigen, Cf (including Cf Control), Cytomegalovirus · 92d
Cleared Feb 13, 1987
AZTREONAM 30 MCG. SENSI-DISC
K865034 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 52d
Cleared Feb 13, 1987
P4802 BEA
K870339 · Lakewood Biochemical Co., Inc.
JSI · Culture Media, Selective And Differential · 16d
Cleared Feb 13, 1987
Z2017, BEA/CNA 5%SB BIPLATE
K870340 · Lakewood Biochemical Co., Inc.
JSI · Culture Media, Selective And Differential · 16d
Cleared Feb 13, 1987
P1012 BE AGAR
K870341 · Lakewood Biochemical Co., Inc.
JSI · Culture Media, Selective And Differential · 16d
Cleared Feb 13, 1987
P3700 COL. CNA W/5% SB
K870342 · Lakewood Biochemical Co., Inc.
JSJ · Culture Media, Selective And Non-differential · 16d
Cleared Feb 06, 1987
BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM
K865021 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTA · Monitor, Microbial Growth · 45d
Cleared Feb 04, 1987
T1365 (BIRD SEED AGAR SLANT)
K870057 · Lakewood Biochemical Co., Inc.
JSI · Culture Media, Selective And Differential · 28d
Cleared Feb 04, 1987
MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
K870134 · Gibco Laboratories Life Technologies, Inc.
JSJ · Culture Media, Selective And Non-differential · 22d

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All categories 5941 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 99 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 75