Cleared Traditional

K083381 - EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

K083381 is the FDA 510(k) clearance for EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) by Euroimmun Us, Inc.. It is a Class 2 Immunology device (product code LRM) cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K083381 · Euroimmun Us, Inc. · Immunology device
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Apr 2009
Decision
152d
Days
Class 2
Risk

K083381 is an FDA 510(k) clearance for the EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG). Classified as Anti-dna Antibody (enzyme-labeled), Antigen, Control (product code LRM), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 152 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. 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 K083381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2008
Decision Date April 15, 2009
Days to Decision 152 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 104d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRM Anti-dna Antibody (enzyme-labeled), Antigen, 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 - LRM Anti-dna Antibody (enzyme-labeled), Antigen, Control

All 13
Devices cleared under the same product code (LRM) and FDA review panel - the closest regulatory comparables to K083381.
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