OVK · Class II · 21 CFR 866.6010

FDA Product Code OVK: Cytokeratin Fragments 21-1 Eia Kit

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.

Leading manufacturers include Fujirebio Diagnostics,Inc..

3
Total
3
Cleared
316d
Avg days
2011
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 264d recently vs 343d historically

FDA 510(k) Cleared Cytokeratin Fragments 21-1 Eia Kit Devices (Product Code OVK)

3 devices
1–3 of 3
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925
Fujirebio Diagnostics,Inc.
Immunology · 264d

About Product Code OVK - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code OVK since 2011, with 3 receiving FDA clearance (average review time: 316 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under OVK have taken an average of 264 days to reach a decision - down from 343 days historically, suggesting improved FDA processing for this classification.

OVK devices are reviewed by the Immunology panel. Browse all Immunology devices →