Cleared Traditional

K112414 - ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY

K112414 is an FDA 510(k) clearance for ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code MSV cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K112414 · Phadia US, Inc. · Immunology device
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Jun 2012
Decision
305d
Days
Class 2
Risk

K112414 is an FDA 510(k) clearance for the ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY. Classified as System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) (product code MSV), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on June 22, 2012 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Phadia US, Inc. devices

FDA 510(k) Submission Details - K112414

510(k) Number K112414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2011
Decision Date June 22, 2012
Days to Decision 305 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 104d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSV Device Classification - Class 2, Special Controls

Product Code MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - MSV System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi)

All 35
Devices cleared under the same product code (MSV) and FDA review panel - the closest regulatory comparables to K112414.
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
QUANTA FLASH ¿2GP1-DOMAIN1
K141274 · Inova Diagnostics, Inc. · Feb 2015
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I
K091556 · Instrumentation Laboratory CO · May 2010
IGG ANTI-ATHEROX TEST KIT
K072032 · Corgenix, Inc. · Apr 2008
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · Immco Diagnostics, Inc. · Sep 2003