Cleared Traditional

EUROIMMUN ANTI-PLA2R ELISA (IGG) (K132195) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K132195 · Euroimmun Us, Inc. · Immunology device
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Jun 2014
Decision
347d
Days
Class 2
Risk

K132195 is an FDA 510(k) clearance for the EUROIMMUN ANTI-PLA2R ELISA (IGG). Classified as Anti-phospholipase A2 Receptor (product code PGV), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on June 27, 2014 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5780 - 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 Euroimmun Us, Inc. devices

Submission Details

510(k) Number K132195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
243d slower than avg
Panel avg: 104d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGV Anti-phospholipase A2 Receptor
Device Class Class 2 - 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.
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.