510(k) · Cleared
ClearedCyfra 21-1 Eia Model 211-10
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 May 26, 2011 as substantially equivalent to K990774 (Abbott Laboratories, 1999) after a 428-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- May 26, 2011
- Review
- 428 days
- Class
- Class II
- Product code
- OVK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990774 (1999). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK990774 Abbott Architect CeaAbbott Laboratories · 1999
- This deviceK100831 Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc. · 2011
- Descendant · cites it directly · 1 of its ownK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
- Descendant · 2 generations on · 0 of its ownK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
- Descendant · cites it directly · 0 of its ownK202852 DiviTum TKaBiovica International AB · 2022
Most influential descendants
Showing 3 of 3 · See all- K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 2016 · cites it directly1descendant
- K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025 · 2 generations on0descendants
- K202852DiviTum TKaBiovica International AB · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990774 | Abbott Architect Cea | Abbott Laboratories | 1999 | — |
| 0 (this device) | K100831 | Cyfra 21-1 Eia Model 211-10 | Fujirebio Diagnostics,Inc. | 2011 | — |
| +1 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | — |
| +2 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025 | — |
| +1 | K202852 | DiviTum TKa | Biovica International AB | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K990774 | Abbott Architect CeaSummary page 1…-1 EIA Test Kit Regulation Number: 21 CFR 866.6010 Regulatory Class: Class 11 Product Code: OVK Predicate Device ARCHITECT CEA (K990774) Device Description The CYFRA 21 -1 EIA is a solid phase, non-competitive immunoassay based on two monoclonal antibodies (deriv… | 1999 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2011, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100831 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100831: Cyfra 21-1 Eia Model 211-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100831
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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