510(k) · Cleared
ClearedADVIA Centaur Cytokeratin Fragment 21-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · OVK Cytokeratin Fragments 21-1 Eia Kit
Cleared on Dec 16, 2025 as substantially equivalent to K160915 (Roche Diagnostics, 2016) after a 264-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Dec 16, 2025
- Review
- 264 days
- Class
- Class II
- Product code
- OVK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K964020 (1997). 10 ancestors in all, the oldest K972235 (1997). No later device cites it as a predicate yet.
- Root · 6 generations backK964020 Axsym CA 125Abbott Laboratories · 1997 · Recalled
- 5 generations backK042731 Architect CA 125 II AssayFujirebio Diagnostics,Inc. · 2004
- 4 generations backK072939 HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008
- 3 generations backK093957 Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls…Fujirebio Diagnostics,Inc. · 2010
- 2 generations backK112624 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys…Roche Diagnostics · 2012
- 1 generation backK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
- This deviceK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964020 | Axsym CA 125 | Abbott Laboratories | 1997 | 4 |
| −5 | K042731 | Architect CA 125 II Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| −4 | K072939 | HE4 Eia, Model: 404-10 US | Fujirebio Diagnostics,Inc. | 2008 | — |
| −3 | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2… | Fujirebio Diagnostics,Inc. | 2010 | — |
| −2 | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4… | Roche Diagnostics | 2012 | — |
| −1 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | — |
| 0 (this device) | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerSummary page 6…light units (RLUs) detected by the system. L. Substantial Equivalence Information: 1. Predicate device name(s): Elecsys CYFRA 21-1 2. Predicate 510(k) number(s): K160915 3. Comparison with predicate (reagents): Similarities… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All OVK devicesOVK Cytokeratin Fragments 21-1 Eia Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OVK
1in 2025
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
MAUDE reports naming product code OVK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA) assay is for in vitro diagnostic use in the quantitative measurement of cytokeratin 19 fragments in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XPT system.
The measurement of cytokeratin 19 is 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 information used for monitoring lung cancer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250925 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250925: ADVIA Centaur Cytokeratin Fragment 21-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250925
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026