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
5931 Microbiology devices
2276–2300 of 5931
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
Cleared Dec 22, 1997
ADENOVIRUS ANTIGEN DETECTION ELISA TEST SYSTEM
K972406 · Immunoprobe, Inc.
GOD · Antigens, Cf (including Cf Control), Adenovirus 1-33 · 179d
Cleared Dec 22, 1997
IMAGEN RESPIRATORY SCREEN
K973954 · Dako Diagnostics , Ltd.
GNW · Antisera, Cf, Influenza Virus A, B, C · 74d
Cleared Dec 11, 1997
ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL
K974261 · Boston Biomedica, Inc.
LJK · Antisera, If, Toxoplasma Gondii · 28d
Cleared Dec 02, 1997
QUANTA LITE TOXOPLASMA IGG
K971441 · Inova Diagnostics, Inc.
LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 228d
Cleared Dec 02, 1997
BACT/ALERT FAN CULTURE BOTTLES
K973325 · Organon Teknika Corp.
MDB · System, Blood Culturing · 89d
Cleared Dec 01, 1997
QUANTA LITE CMV IGG ELISA
K971335 · Inova Diagnostics, Inc.
LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 235d
Cleared Dec 01, 1997
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · Oxoid , Ltd.
JTN · Susceptibility Test Discs, Antimicrobial · 77d
Cleared Nov 18, 1997
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · Diagnostic Hybrids, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 203d

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All categories 5931 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