Cleared Traditional

ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM (K102425) - FDA 510(k) Clearance

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

K102425 · Zeus Scientific, Inc. · Immunology device
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Dec 2011
Decision
474d
Days
Class 2
Risk

K102425 is an FDA 510(k) clearance for the ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM. Classified as System, Test, Anticardiolipin Immunological (product code MID), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 12, 2011 after a review of 474 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K102425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2010
Decision Date December 12, 2011
Days to Decision 474 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
370d slower than avg
Panel avg: 104d · This submission: 474d
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 18
Devices cleared under the same product code (MID) and FDA review panel - the closest regulatory comparables to K102425.
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THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
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THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
K984347 · Zeus Scientific, Inc. · Dec 1998