Cleared Traditional

VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 (K023433) - FDA 510(k) Clearance

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

K023433 · Pharmacia Diagnostics GmbH & Co. KG · Immunology device
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Nov 2002
Decision
29d
Days
Class 2
Risk

K023433 is an FDA 510(k) clearance for the VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Pharmacia Diagnostics GmbH & Co. KG (Freiburg, DE). The FDA issued a Cleared decision on November 13, 2002 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pharmacia Diagnostics GmbH & Co. KG devices

Submission Details

510(k) Number K023433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date November 13, 2002
Days to Decision 29 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
75d faster than avg
Panel avg: 104d · This submission: 29d
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.