Cleared Traditional

K130528 - BIOPLEX 2200 APLS IGM (FDA 510(k) Clearance)

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

K130528 · Bio-Rad Laboratories · Immunology device
Oct 2013
Decision
234d
Days
Class 2
Risk

K130528 is an FDA 510(k) clearance for the BIOPLEX 2200 APLS IGM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on October 21, 2013 after a review of 234 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.

Submission Details

510(k) Number K130528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2013
Decision Date October 21, 2013
Days to Decision 234 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 277d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MID System, Test, Anticardiolipin Immunological
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.