Not Cleared Post-NSE

DEN140002 - EUROIMMUN ANTI-PLA2R IFA

DEN140002 is an FDA 510(k) submission for EUROIMMUN ANTI-PLA2R IFA, manufactured by Euroimmun US. The device is a Class 2 Immunology device with product code PGV cleared through the Post-NSE 510(k) pathway after a 62-day FDA review.

DEN140002 · Euroimmun US · Immunology device
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May 2014
Decision
62d
Days
Class 2
Risk

DEN140002 is an FDA 510(k) submission (not cleared) for the EUROIMMUN ANTI-PLA2R IFA. Classified as Anti-phospholipase A2 Receptor (product code PGV), Class II - Special Controls.

Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Not Cleared (DENG) decision on May 29, 2014 after a review of 62 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Immunology review framework.

FDA 510(k) Submission Details - DEN140002

510(k) Number DEN140002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 28, 2014
Decision Date May 29, 2014
Days to Decision 62 days
Submission Type Post-NSE
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 105d · This submission: 62d
Pathway characteristics

PGV Device Classification - Class 2, Special Controls

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.

DEN140002 · EUROIMMUN ANTI-PLA2R IFA
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