Cleared Traditional

K130053 - BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CELIAC IGA AND IGG CALIBRATOR SETS, AND BI (FDA 510(k) Clearance)

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

K130053 · Bio-Rad Laboratories, Inc. · Immunology device
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Sep 2013
Decision
247d
Days
Class 2
Risk

K130053 is an FDA 510(k) clearance for the BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200.... Classified as Autoantibodies, Endomysial(tissue Transglutaminase) (product code MVM), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on September 19, 2013 after a review of 247 days - an extended review cycle.

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.

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Submission Details

510(k) Number K130053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2013
Decision Date September 19, 2013
Days to Decision 247 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
143d slower than avg
Panel avg: 104d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MVM Autoantibodies, Endomysial(tissue Transglutaminase)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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.