DeviceClearance

Product code OVK— Immunology

ADVIA Centaur Cytokeratin Fragment 21-1

Classification name
Cytokeratin Fragments 21-1 Eia Kit
Device class
Class 2
Regulation
21 CFR 866.6010
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OVK under 21 CFR 866.6010, via openFDA

Market context for product code OVK

FDA has cleared 3 devices under product code OVK between 2011 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OVK

Recent clearances under product code OVK

Data sourced from openFDA. This site is unofficial and independent of the FDA.