ADVIA Centaur Cytokeratin Fragment 21-1

FDA 510(k) K250925 · Fujirebio Diagnostics,Inc.

Substantially Equivalent

510(k) numberK250925

Submission

Device name
ADVIA Centaur Cytokeratin Fragment 21-1
Applicant
Fujirebio Diagnostics,Inc.
Malvern, PA, US
Received
March 27, 2025
Decision date
December 16, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OVK – Cytokeratin Fragments 21-1 Eia Kit
Device class
Class II (moderate risk)
Regulation
21 CFR 866.6010
Specialty
Immunology

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.

Other 510(k)s with product code OVK

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K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerOVK · Traditional Roche Diagnostics12/14/2016SE
K100831Cyfra 21-1 Eia Model 211-10OVK · Traditional Fujirebio Diagnostics,Inc.05/26/2011SE

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Questions and answers

When was ADVIA Centaur Cytokeratin Fragment 21-1 cleared by the FDA?

ADVIA Centaur Cytokeratin Fragment 21-1 (K250925) received a 510(k) decision of Substantially Equivalent on December 16, 2025, 264 days after the submission was received.

What is the product code of K250925?

The FDA product code is OVK – Cytokeratin Fragments 21-1 Eia Kit, a Class II (moderate risk) device regulated under 21 CFR 866.6010.