K160915 is an FDA 510(k) clearance for the Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker. This device is classified as a Cytokeratin Fragments 21-1 Eia Kit (Class II - Special Controls, product code OVK).
Submitted by Roche Diagnostics (Indianapolis, 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 FDA review panel. Regulated under 21 CFR 866.6010. 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..
| 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 |
| 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. |