510(k) · Cleared
ClearedElecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · OVK Cytokeratin Fragments 21-1 Eia Kit
Cleared on Dec 14, 2016 as substantially equivalent to K100831 (Fujirebio Diagnostics,Inc., 2011) and 2 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Dec 14, 2016
- Review
- 257 days
- Class
- Class II
- Product code
- OVK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K964020 (1997). 9 ancestors in all, the oldest K972235 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK964020 Axsym CA 125Abbott Laboratories · 1997 · Recalled
- 4 generations backK042731 Architect CA 125 II AssayFujirebio Diagnostics,Inc. · 2004
- 3 generations backK072939 HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008
- 2 generations backK093957 Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls…Fujirebio Diagnostics,Inc. · 2010
- 1 generation backK112624 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys…Roche Diagnostics · 2012
- This deviceK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
- Descendant · cites it directly · 0 of its ownK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964020 | Axsym CA 125 | Abbott Laboratories | 1997 | 4 |
| −4 | K042731 | Architect CA 125 II Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| −3 | K072939 | HE4 Eia, Model: 404-10 US | Fujirebio Diagnostics,Inc. | 2008 | — |
| −2 | K093957 | Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2… | Fujirebio Diagnostics,Inc. | 2010 | — |
| −1 | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4… | Roche Diagnostics | 2012 | — |
| 0 (this device) | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
Top candidate predicates for a new OVK device
- #1 K250925 ADVIA Centaur Cytokeratin Fragment 21-1score 12.0 · 6 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K100831 | Cyfra 21-1 Eia Model 211-10Summary page 6…icate Device: Candidate Device: Feature Fujirebio CYFRA 21-1 EIA Elecsys CYFRA 21-1 (K100831) General Assay Features Intended Use/ The CYFRA 21-1 EIA kit is intended Immunoassay f… | 2011 |
| * | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5Summary page 8…jirebio CYFRA 21-1 EIA Elecsys CYFRA 21-1 Feature (K100831) and Elecsys HE4 PreciControl (K112624) General Assay Features Calibration Calibration curves are determined Calibra… | 2012 |
| * | K050387 | Roche Diagnostics Elecsys Precicontrol TumorSummary page 13…Device: Candidate Device: PreciControl Tumor Marker PreciControl Tumor Marker (K050387) Modified to Include CYFRA 21-1 Intended Use PreciControl Tumor Marker is used PreciControl Tumor Marker is… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | 2025 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K250925 (Fujirebio Diagnostics,Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100831.
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. 2016, 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?
Elecsys CYFRE 21-1: Immunoassay for the in vitro quantitative determination of fragments of cytokeratin 19 in human serum and plasma (Li-Heparin, K2-EDTA and K3-EDTA). 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. The…
Read the full statement (131 words)
Elecsys CYFRE 21-1:
Immunoassay for the in vitro quantitative determination of fragments of cytokeratin 19 in human serum and plasma (Li-Heparin, K2-EDTA and K3-EDTA). 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.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys CYFRA 21-1 CalSet:
CYFRA 21-1 is used for calibrating the quantitative Elecsys CYFRA 21-1 assay on the Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Tumor Marker:
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160915
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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