Cleared Traditional

EUROIMMUN Anti-BP230-CF ELISA (IgG) (K193115) - FDA 510(k) Clearance

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

K193115 · Euroimmun Us, Inc. · Immunology device
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Sep 2020
Decision
310d
Days
Class 2
Risk

K193115 is an FDA 510(k) clearance for the EUROIMMUN Anti-BP230-CF 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. (Mountain Lakes, US). The FDA issued a Cleared decision on September 17, 2020 after a review of 310 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 K193115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2019
Decision Date September 17, 2020
Days to Decision 310 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 104d · This submission: 310d
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.