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
4226–4250 of 5941
Cleared Mar 11, 1986
API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC
K860369 · Analytical Products, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 36d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS RIFAMPIN 15 MCG
K860560 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS PENICILLIN G 2 UNITS
K860561 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS COLISTIN 10 MCG
K860562 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS VANCOMYCIN 5 MCG
K860563 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS ERYTHROMYCIN 60 MCG
K860564 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 11, 1986
DIFFERENTIATION DISKS KANAMYCIN 1000 MCG
K860565 · Difco Laboratories, Inc.
JTO · Discs, Strips And Reagents, Microorganism Differentiation · 25d
Cleared Mar 11, 1986
OFPBL
K860707 · Remel Co.
JSI · Culture Media, Selective And Differential · 13d
Cleared Mar 10, 1986
CELLMATICS CHLAMYDIA MONOCLONAL DFA REAGENT
K860179 · Difco Laboratories, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 52d
Cleared Mar 10, 1986
PSEUDOMONAS AGAR P (MEDIUM A)
K860750 · Gibco Laboratories Life Technologies, Inc.
JSH · Culture Media, Non-selective And Differential · 10d
Cleared Mar 06, 1986
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K855106 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTT · Susceptibility Test Powders, Antimicrobial · 73d
Cleared Mar 06, 1986
IMIPENEM 10 MCG SENSITIVITY DISCS
K855207 · Difco Laboratories, Inc.
JTT · Susceptibility Test Powders, Antimicrobial · 66d
Cleared Mar 06, 1986
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
K860031 · Organon Teknika Corp.
JTT · Susceptibility Test Powders, Antimicrobial · 59d
Cleared Mar 04, 1986
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc.
JSS · Kit, Identification, Enterobacteriaceae · 231d
Cleared Mar 04, 1986
NEG COMBO BREAKPOINT PANEL POS COMBO
K854278 · American Micro Scan
JWX · Kit, Screening, Staphylococcus Aureus · 131d
Cleared Mar 04, 1986
OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS
K860153 · Oxoid U.S.A., Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 48d
Cleared Mar 04, 1986
ROTALEX
K860529 · Orion Corp.
LIQ · Enzyme Linked Immunoabsorbent Assay, Rotavirus · 21d
Cleared Mar 03, 1986
V-TREND KIT STAPH LATEX TEST
K855220 · Texas Immunology, Inc.
JWX · Kit, Screening, Staphylococcus Aureus · 63d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSITIVITY DISCS
K860527 · Difco Laboratories, Inc.
JTN · Susceptibility Test Discs, Antimicrobial · 20d
Cleared Mar 03, 1986
CEFOTETAN 30 MCG SENSI DISC
K860536 · Bd Becton Dickinson Vacutainer Systems Preanalytic
JTN · Susceptibility Test Discs, Antimicrobial · 19d
Cleared Feb 24, 1986
BIOTIS CLOSTRIDIUM DIFFICILE AGAR
K860383 · Otisville Biotech, Inc.
JSJ · Culture Media, Selective And Non-differential · 21d
Cleared Feb 24, 1986
BIOTIS MODIFIED THAYER MARTIN
K860384 · Otisville Biotech, Inc.
JTY · Culture Media, For Isolation Of Pathogenic Neisseria · 21d
Cleared Feb 24, 1986
BIOTIS MAC-MUG
K860385 · Otisville Biotech, Inc.
JSI · Culture Media, Selective And Differential · 21d
Cleared Feb 24, 1986
BIOTIS SF BROTH
K860386 · Otisville Biotech, Inc.
JSI · Culture Media, Selective And Differential · 21d
Cleared Feb 24, 1986
BIOTIS KF STREPTOCOCCUS AGAR
K860388 · Otisville Biotech, Inc.
JSI · Culture Media, Selective And Differential · 21d

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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