Cleared Traditional

EUROIMMUN ANTI-PLA2R ELISA (IGG)

K132195 · Euroimmun Us, Inc. · Immunology

Jun 2014

Decision

347d

Days

Class 2

Risk

About This 510(k) Submission

K132195 is an FDA 510(k) clearance for the EUROIMMUN ANTI-PLA2R ELISA (IGG), a Anti-phospholipase A2 Receptor (Class II — Special Controls, product code PGV), submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on June 27, 2014, 347 days after receiving the submission on July 15, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5780.

Submission Details

510(k) Number	K132195 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2013
Decision Date	June 27, 2014
Days to Decision	347 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	PGV — Anti-phospholipase A2 Receptor
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5780
Definition	The Test System Is Intended For The Qualitative Determination Of Igg Class Autoantibodies Against Phospholipase A2 Receptor (pla2r) In Human Serum. It Is Used As An Aid In The Diagnosis Of Primary Membranous Glomerulonephritis (pmgn), In Conjunction With Other Laboratory And Clinical Findings.