Cleared Traditional

QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS.

K141274 · Inova Diagnostics, Inc. · Immunology
Feb 2015
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K141274 is an FDA 510(k) clearance for the QUANTA FLASH ?2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-?2GPI DOMAIN1; CONTROLS., a System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (Class II — Special Controls, product code MSV), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 13, 2015, 273 days after receiving the submission on May 16, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K141274 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2014
Decision Date February 13, 2015
Days to Decision 273 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
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. · Jun 2017
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
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