Cleared Traditional

K103834 - BIOPLEX 2200 APLS IGG AND IGA KIT AND C...

K103834 is the FDA 510(k) clearance for BIOPLEX 2200 APLS IGG AND IGA KIT AND C... by Bio-Rad Laboratories. It is a Class 2 Immunology device (product code MID) cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K103834 · Bio-Rad Laboratories · Immunology device
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Mar 2012
Decision
456d
Days
Class 2
Risk

K103834 is an FDA 510(k) clearance for the BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS. 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 March 30, 2012 after a review of 456 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.

View all Bio-Rad Laboratories devices

Submission Details

510(k) Number K103834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2010
Decision Date March 30, 2012
Days to Decision 456 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
352d slower than avg
Panel avg: 104d · This submission: 456d
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 K103834.
BIOPLEX 2200 APLS IGM
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IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
K113020 · Immco Diagnostics, Inc. · Oct 2012
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · Zeus Scientific, Inc. · Dec 2011
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181 · Instrumentation Laboratory CO · Mar 2010
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240 · The Binding Site, Ltd. · Sep 2003