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510(k) K100831

CYFRA 21-1 EIA MODEL 211-10 by Fujirebio Diagnostics,Inc. — Product Code OVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 2011
Date Received
March 24, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cytokeratin Fragments 21-1 Eia Kit
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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.

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  • K200997 — Lumipulse G CA19-9-N (May 14, 2020)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171103 — Lumipulse G TSH-III Immunoreaction Cartridges (July 28, 2017)
  • K163546 — Lumipulse G Progesterone-N Calibrators (January 13, 2017)

Other clearances for product code OVK

  • K250925 — ADVIA Centaur Cytokeratin Fragment 21-1 (December 16, 2025)
  • K160915 — Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (December 14, 2016)