Cleared Traditional

Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker

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

About This 510(k) Submission

K160915 is an FDA 510(k) clearance for the Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker, a Cytokeratin Fragments 21-1 Eia Kit (Class II — Special Controls, product code OVK), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on December 14, 2016, 257 days after receiving the submission on April 1, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K160915 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code OVK — Cytokeratin Fragments 21-1 Eia Kit
Device Class Class II — 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.