Cleared Traditional

K112996 - EUROIMMUN ANTI-ENA POOL ELISA (IGG)

K112996 is an FDA 510(k) clearance for EUROIMMUN ANTI-ENA POOL ELISA (IGG), manufactured by Euroimmun US. The device is a Class 2 Immunology device with product code LLL cleared through the Traditional 510(k) pathway after a 550-day FDA review.

K112996 · Euroimmun US · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
550d
Days
Class 2
Risk

K112996 is an FDA 510(k) clearance for the EUROIMMUN ANTI-ENA POOL ELISA (IGG). Classified as Extractable Antinuclear Antibody, Antigen And Control (product code LLL), Class II - Special Controls.

Submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on April 9, 2013 after a review of 550 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Euroimmun US devices

FDA 510(k) Submission Details - K112996

510(k) Number K112996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2011
Decision Date April 09, 2013
Days to Decision 550 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
446d slower than avg
Panel avg: 104d · This submission: 550d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLL Device Classification - Class 2, Special Controls

Product Code LLL Extractable Antinuclear Antibody, Antigen And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LLL Extractable Antinuclear Antibody, Antigen And Control

All 136
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