Cleared Traditional

K160915 - Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (FDA 510(k) Clearance)

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

K160915 · Roche Diagnostics · Immunology device
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Dec 2016
Decision
257d
Days
Class 2
Risk

K160915 is an FDA 510(k) clearance for the Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker. Classified as Cytokeratin Fragments 21-1 Eia Kit (product code OVK), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 14, 2016 after a review of 257 days - an extended review cycle.

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. Standard predicate reliance. 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 K160915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2016
Decision Date December 14, 2016
Days to Decision 257 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
153d slower than avg
Panel avg: 104d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OVK Cytokeratin Fragments 21-1 Eia Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
Definition The Cyfra 21-1 Eia Kit Is Intended For The Quantitative Determination Of Soluble Cytokeratin 19 Fragments In Human Serum. The Assay Is To Be Used As An Aid In Monitoring Disease Progression During The Course Of Disease And Treatment In Lung Cancer Patients. Serial Testing For Patient Cyfra 21-1 Assay Values Should Be Used In Conjunction With Other Clinical Methods Used For Monitoring Lung Cancer.
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.