Cleared Traditional

BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (K043341) - FDA 510(k) Clearance

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

K043341 · Bio-Rad Laboratories, Inc. · Immunology device
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Oct 2005
Decision
328d
Days
Class 2
Risk

K043341 is an FDA 510(k) clearance for the BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH B.... Classified as Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease (product code NVI), Class II - Special Controls.

Submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on October 27, 2005 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3100 - 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. Elevated predicate reliance profile. 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 K043341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 2004
Decision Date October 27, 2005
Days to Decision 328 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
224d slower than avg
Panel avg: 104d · This submission: 328d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NVI Diagnostic Software, K-nearest Neighbor Algorithm, Autoimmune Disease
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
Definition The Device Is Intended To Suggest A Systemic Autoimmune Disease Association As An Aid For Differential Diagnosis To Be Evaluated In Conjunction With Clinical Findings And Other Laboratory Tests.
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.