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

7048

Total

6986

Cleared

159d

Avg (2y)

1976

Since

1404 Microbiology devices

926–950 of 1404

Cleared Feb 06, 2002

MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML)

K020246 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 13d

Cleared Feb 06, 2002

MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML)

K020249 · Dade Behring, Inc.

LON · System, Test, Automated, Antimicrobial Susceptibility, Short Incubation · 13d

Cleared Jan 10, 2002

IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6

K012075 · Diagnostic Products Corp.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 192d

Cleared Jan 10, 2002

IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6

K012077 · Diagnostic Products Corp.

LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 192d

Cleared Nov 30, 2001

INFLUENZA A/B RAPID TEST, CAT NO 2158 663

K011684 · Roche Diagnostics Corp.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 184d

Cleared Aug 22, 2001

DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K010418 · Dade Behring, Inc.

LTT · Panels, Test, Susceptibility, Antimicrobial · 191d

Cleared Jun 13, 2001

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479

K003259 · Beckman Coulter, Inc.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 238d

Cleared Jun 06, 2001

BACTEC MGIT 960 SIR KITS

K003062 · Bd Becton Dickinson Vacutainer Systems Preanalytic

MJA · Susceptibility Test Powders, Antimycobacterial · 247d

Cleared Apr 18, 2001

MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

K010878 · Diagnostic Products Corp.

LGC · Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific · 30d

Cleared Oct 04, 2000

VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192

K001460 · bioMerieux, Inc.

LYR · Helicobacter Pylori · 147d

Cleared Aug 31, 2000

ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479

K002453 · Beckman Coulter, Inc.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 21d

Cleared Jun 28, 2000

BD DIRECTIGEN FLU A+B

K001364 · Bd Becton Dickinson Vacutainer Systems Preanalytic

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 58d

Cleared Jun 01, 2000

IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG

K000463 · Diagnostic Products Corp.

LYR · Helicobacter Pylori · 111d

Cleared May 22, 2000

VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210

K993319 · bioMerieux, Inc.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 231d

Cleared Apr 25, 2000

MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

K000762 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTN · Susceptibility Test Discs, Antimicrobial · 48d

Cleared Apr 13, 2000

GATIFLOXACIN, 5 UG, BBL SENSI-DISC

K000829 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTN · Susceptibility Test Discs, Antimicrobial · 30d

Cleared Dec 20, 1999

ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST

K993048 · Roche Diagnostics Corp.

PSZ · Devices Detecting Influenza A, B, And C Virus Antigens · 101d

Cleared Dec 16, 1999

IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6

K993952 · Diagnostic Products Corp.

LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus · 24d

Cleared Nov 03, 1999

SYNERCID, 15 UG, BBL SENSI-DISC

K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic

JTN · Susceptibility Test Discs, Antimicrobial · 42d

Cleared Mar 18, 1999

PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1

K983336 · Diagnostic Products Corp.

LKT · Respiratory Syncytial Virus, Antigen, Antibody, Ifa · 176d

Cleared Dec 11, 1998

IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS)

K982078 · Diagnostic Products Corp.

LFX · Enzyme Linked Immunoabsorbent Assay, Rubella · 179d

Cleared Nov 18, 1998

ABBOTT TESTPACK PLUS H. PYLORI

K982362 · Abbott Laboratories

LYR · Helicobacter Pylori · 135d

Cleared Sep 17, 1998

ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469

K973448 · Beckman Instruments, Inc.

LGD · Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii · 371d

Cleared Aug 06, 1998

K981263 · Instrumentation Laboratory CO

GMM · Antigens, Iha, Toxoplasma Gondii · 121d

Cleared Jul 17, 1998

COLORPAC TOXIN A

K980185 · Bd Becton Dickinson Vacutainer Systems Preanalytic

LLH · Reagents, Clostridium Difficile Toxin · 178d

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