Cleared Traditional

K130528 - BIOPLEX 2200 APLS IGM

K130528 is the FDA 510(k) clearance for BIOPLEX 2200 APLS IGM by Bio-Rad Laboratories. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K130528 · Bio-Rad Laboratories · Immunology device
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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.

View all Bio-Rad Laboratories devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 104d · 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.

Regulatory Peers - MID System, Test, Anticardiolipin Immunological

All 43
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K130528.
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