Cleared Traditional

CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964098) - FDA 510(k) Clearance

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

K964098 · Bayer Corp. · Immunology device
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Oct 1997
Decision
385d
Days
Class 2
Risk

K964098 is an FDA 510(k) clearance for the CPA 125 II ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM. Classified as Test, Epithelial Ovarian Tumor-associated Antigen (ca125) (product code LTK), Class II - Special Controls.

Submitted by Bayer Corp. (Tarrytown, US). The FDA issued a Cleared decision on October 31, 1997 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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.

View all Bayer Corp. devices

Submission Details

510(k) Number K964098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1996
Decision Date October 31, 1997
Days to Decision 385 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
281d slower than avg
Panel avg: 104d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
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 - LTK Test, Epithelial Ovarian Tumor-associated Antigen (ca125)

All 25
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K080469 · bioMerieux, Inc. · Jun 2009
VIDAS CA 125 II ASSAY
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