Cleared Traditional

EUROIMMUN ANTI BP 180-4X ELISA (IGG) (K083615) - FDA 510(k) Clearance

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

K083615 · Euroimmun Us, Inc. · Immunology device
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Mar 2009
Decision
98d
Days
Class 2
Risk

K083615 is an FDA 510(k) clearance for the EUROIMMUN ANTI BP 180-4X ELISA (IGG). Classified as Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 (product code OEG), Class II - Special Controls.

Submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on March 16, 2009 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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 K083615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2008
Decision Date March 16, 2009
Days to Decision 98 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
6d faster than avg
Panel avg: 104d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OEG Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
Definition The Device Is Intended As An Aid In The Diagnosis Of Bullous Pemphigoid.
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.