Cleared Traditional

ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA

K162788 · Immco Diagnostics, Inc. · Immunology
Jun 2017
Decision
259d
Days
Class 2
Risk

About This 510(k) Submission

K162788 is an FDA 510(k) clearance for the ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA, a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on June 19, 2017, 259 days after receiving the submission on October 3, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K162788 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2016
Decision Date June 19, 2017
Days to Decision 259 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MSV — System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

Similar Devices — MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 45
Aptiva APS IgA Reagent
K243979 · Inova Diagnostics, Inc. · Feb 2026
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K181329 · Phadia AB · Jun 2018
QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls
K152875 · Inova Diagnostics, Inc. · Dec 2015
QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS.
K141274 · Inova Diagnostics, Inc. · Feb 2015
ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY
K112414 · Phadia US, Inc. · Jun 2012
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS
K091556 · Instrumentation Laboratory CO · May 2010