Cleared Traditional

MESACUP MODELS BP180 AND BP230 ELISA KITS (K071961) - FDA 510(k) Clearance

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

K071961 · Mbl International Corporation · Immunology device
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Aug 2008
Decision
406d
Days
Class 2
Risk

K071961 is an FDA 510(k) clearance for the MESACUP MODELS BP180 AND BP230 ELISA KITS. Classified as Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 (product code OEG), Class II - Special Controls.

Submitted by Mbl International Corporation (Deer Field, US). The FDA issued a Cleared decision on August 25, 2008 after a review of 406 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: 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.

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Submission Details

510(k) Number K071961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date August 25, 2008
Days to Decision 406 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
302d slower than avg
Panel avg: 104d · This submission: 406d
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.