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
2426–2450 of 7095
Cleared Mar 10, 1998
PYLORI DETECT IGG
K973508 · Micro Detect, Inc.
LYR · Helicobacter Pylori · 175d
Cleared Mar 03, 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II
K971522 · Abbott Laboratories
GTZ · Antisera, All Groups, Streptococcus Spp. · 312d
Cleared Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523 · Boehringer Mannheim Corp.
LYR · Helicobacter Pylori · 167d
Cleared Feb 26, 1998
ALIMENTERICS LARA (TM) BREATH TEST SYSTEM
K973000 · Alimenterics, Inc.
MSQ · Test, Urea (breath Or Blood) · 198d
Cleared Feb 23, 1998
URINE SCREENING DEVICE
K972676 · Combact Diagnostic Systems , Ltd.
JXA · Kit, Screening, Urine · 222d
Cleared Feb 23, 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · Becton Dickinson Microbiology Systems
JTN · Susceptibility Test Discs, Antimicrobial · 77d
Cleared Feb 20, 1998
DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
K972904 · Casco Standards
JJY · Multi-analyte Controls, All Kinds (assayed) · 198d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGG WESTERN BLOT (90111)
K971169 · Cambridge Biotech Corp.
LSR · Reagent, Borrelia Serological Reagent · 326d
Cleared Feb 17, 1998
CAMBRIDGE BIOTECH HUMAN LYME IGM WESTERN BLOT (90112)
K971170 · Cambridge Biotech Corp.
LSR · Reagent, Borrelia Serological Reagent · 326d
Cleared Feb 12, 1998
PASCO MIC AND MIC/ID PANELS
K974362 · Pasco Laboratories, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 85d
Cleared Feb 10, 1998
ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL
K974811 · Boston Biomedica, Inc.
JJX · Single (specified) Analyte Controls (assayed And Unassayed) · 49d
Cleared Feb 05, 1998
ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL
K974809 · Boston Biomedica, Inc.
LSR · Reagent, Borrelia Serological Reagent · 44d
Cleared Feb 05, 1998
ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL
K974810 · Boston Biomedica, Inc.
LSR · Reagent, Borrelia Serological Reagent · 44d
Cleared Jan 28, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970333 · Becton Dickinson Microbiology Systems
MDB · System, Blood Culturing · 365d
Cleared Jan 28, 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 271d
Cleared Jan 28, 1998
DIAMEDIX IS-MEASLES IGG TEST SYSTEM
K974552 · Diamedix Corp.
LJB · Enzyme Linked Immunoabsorbent Assay, Rubeola Igg · 55d
Cleared Jan 27, 1998
VIROTROL III
K974613 · Blackhawk Biosystems, Inc.
JJY · Multi-analyte Controls, All Kinds (assayed) · 47d
Cleared Jan 22, 1998
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · Accumed Intl., Inc.
LQL · Gram Positive Identification Panel · 196d
Cleared Jan 14, 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 55d
Cleared Jan 08, 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · Becton Dickinson Microbiology Systems
MDB · System, Blood Culturing · 331d
Cleared Jan 02, 1998
QUANTA LITE REBELLA IGG
K971304 · Inova Diagnostics, Inc.
LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 269d
Cleared Jan 02, 1998
CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800
K973457 · Shared Systems, Inc.
GMZ · Antigens, All Types, Escherichia Coli · 112d
Cleared Dec 30, 1997
WELLCOLEX E.COLI O157:H7
K971663 · Murex Biotech , Ltd.
GMZ · Antigens, All Types, Escherichia Coli · 238d
Cleared Dec 24, 1997
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · Scantibodies Laboratory, Inc.
MJX · Kit, Serological, Positive Control · 41d
Cleared Dec 23, 1997
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 235d

Looking for a specific microbiology device? Search by device name, K-number or manufacturer.

Search all Microbiology 510(k) devices

Filter by Product Code

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