510(k) Report

FDA product code · Immunology

Cytokeratin Fragments 21-1 Eia Kit

OVKClass II21 CFR 866.6010510(k) required3 decisions since 20110 recalls

3 FDA decisions since 2011. 510(k) reviews decided 2021–2025 took a median of 264 days (half between 264 and 264). No recall names this code. The most-cited predicate is K100831, named by 2 later devices.

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.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, immunology panel

Twenty years of OVK at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · OVK

1in 2025

2011: 12016: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OVK

Too few OVK 510(k)s in any year since 2007 to give a median.

Recalls per year · OVK

No recall names OVK since 2007.

Adverse event reports per year · OVK

1in 2025

2020: 22022: 12023: 22024: 22025: 1
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code OVK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20190—00
20200—02
20210—00
20220—01
20230—02
20240—02
20251—01
20260—0—
FIG. 1 — OVK by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in OVK? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do OVK devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K100831Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc. · 20112cite it
  • K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 20161cites it

Which OVK devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 20256generations
  • K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 20165generations
  • K100831Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc. · 20111generation

What has FDA decided in OVK lately?

  • K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
  • K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 2016
  • K100831Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc. · 2011

All 3 OVK decisions →

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