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
5928 Microbiology devices
1401–1425 of 5928
Cleared Jan 22, 2008
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K073424 · Trek Diagnostic Systems, Inc.
JWY · Manual Antimicrobial Susceptibility Test Systems · 48d
Cleared Jan 14, 2008
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML
K073433 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 39d
Cleared Jan 04, 2008
PROFLU+ ASSAY
K073029 · Prodesse, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 67d
Not Cleared Jan 03, 2008
ID-TAG RESPIRATORY VIRAL PANEL
DEN070013 · Luminex Molecular Diagnostics, Inc.
OCC · Respiratory Virus Panel Nucleic Acid Assay System · 30d
Cleared Dec 21, 2007
VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118
K072138 · bioMerieux, Inc.
LLH · Reagents, Clostridium Difficile Toxin · 141d
Cleared Dec 20, 2007
BD GENEOHM STAPHSR ASSAY
K071026 · Bd Diagnostics (Geneohm Sciences Canada, Inc)
NQX · System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen · 253d
Cleared Dec 20, 2007
JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
K072631 · Idaho Technology, Inc.
NHT · Assay, Nucleic Acid Amplification, Bacillus Anthracis · 93d
Cleared Dec 19, 2007
JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124
K072547 · Idaho Technology, Inc.
OEH · Joint Biological Agent Identification And Diagnostic System (jbaids) Tularemia Detection Kit · 100d
Cleared Dec 10, 2007
VITEK 2 GRAM NEGATIVE PIPERACILLIN
K073083 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 39d
Cleared Nov 26, 2007
RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
K072827 · Remel, Inc.
MJE · Culture Media, Antifungal, Susceptibility Test · 54d
Cleared Nov 20, 2007
BBL CHROMAGAR 0157
K070691 · Becton, Dickinson & CO
JSI · Culture Media, Selective And Differential · 252d
Cleared Nov 16, 2007
VITEK 2 GRAM POSITIVE TIGECYCLINE
K072695 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 53d
Cleared Nov 15, 2007
TRU FLU
K071657 · Meridian Bioscience, Inc.
PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 150d
Cleared Oct 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
K070265 · Diagnostic Hybrids, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 268d
Cleared Oct 18, 2007
TRU RSV
K071101 · Meridian Bioscience, Inc.
GOG · Antisera, Cf, Poliovirus 1-3 · 182d
Cleared Oct 15, 2007
VITEK 2 GRAM POSITIVE VANCOMYCIN
K072668 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 24d
Cleared Oct 11, 2007
VIDAS B.R.A.H.M.S. PCT ASSAY
K071146 · bioMerieux, Inc.
NTM · Antigen, Inflammatory Response Marker, Sepsis · 170d
Cleared Oct 05, 2007
PLEXUS HERPESELECT 1 AND 2 IGG (WITH PLEXUS TM SOFTWARE), MODEL MP0900G
K071511 · Focus Diagnostics, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 123d
Cleared Oct 02, 2007
MODIFICATION TO BIOSTAR OIA SHIGATOX
K071799 · Iverness Medical Professional Diagnostics
GNA · Antisera, All Types, Escherichia Coli · 92d
Cleared Sep 24, 2007
DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT
K063675 · Diagnostic Hybrids, Inc.
LJP · Antiserum, Fluorescent, Chlamydia Trachomatis · 287d
Cleared Sep 24, 2007
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML
K070809 · Becton, Dickinson & CO
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 182d
Cleared Sep 24, 2007
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
K071510 · Focus Diagnostics, Inc.
MXJ · Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 · 112d
Cleared Sep 21, 2007
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
K063798 · Diagnostic Hybrids, Inc.
GQN · Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 · 273d
Cleared Sep 13, 2007
MRSASELECT
K070361 · Bio-Rad
JSO · Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar · 218d
Cleared Sep 12, 2007
VITEK 2 GRAM NEGATIVE LEVOFLOXACIN
K072038 · bioMerieux, Inc.
LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 49d

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All categories 5928 JWY Manual Antimicrobial Susceptibility Test Systems 407 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 LYR Helicobacter Pylori 75 OCC Respiratory Virus Panel Nucleic Acid Assay System 74