DiviTum TKa

K202852510(k) TraditionalCleared Jul 29, 2022669-day reviewClass II21 CFR 866.6010

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

Biovica International AB · QTE Thymidine Kinase Activity

Cleared on Jul 29, 2022 as substantially equivalent to K100831 (Fujirebio Diagnostics,Inc., 2011) after a 669-day review. Its family tree reaches back 2 generations to 1999.

Decided: Jul 29, 2022
Review: 669 days
Class: Class II
Product code: QTE
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K990774 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK990774 Abbott Architect CeaAbbott Laboratories · 1999
1 generation backK100831 Cyfra 21-1 Eia Model 211-10Fujirebio Diagnostics,Inc. · 2011
This deviceK202852 DiviTum TKaBiovica International AB · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K990774	Abbott Architect Cea	Abbott Laboratories	1999	—
−1	K100831	Cyfra 21-1 Eia Model 211-10	Fujirebio Diagnostics,Inc.	2011	—
0 (this device)	K202852	DiviTum TKa	Biovica International AB	2022	—

FIG. 1 — Lineage of K202852, 1999–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 QTE? 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K100831	Cyfra 21-1 Eia Model 211-10 Summary page 6 …SUBSTANTIAL EQUIVALENCE INFORMATION: 1. Predicate Device Name(s): CYFRA 21-1 (soluble cytokeratin 19 fragments) 2. Predicate 510(k) Number(s): K100831 3. Comparison with Predicate: Table 2- Summary Predicate Comparison – Similarities Device Name DiviTum® T…	Fujirebio Diagnostics,Inc.	2011	—

Also cleared against K100831: 1 other device →

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 23 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K100831.

How does its category compare?

All QTE devices

QTE Thymidine Kinase Activity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · QTE

1in 2022

2007high 1 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QTE

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

Recalls per year · QTE

No recall names QTE since 2007.

Adverse event reports per year · QTE

No MAUDE report names QTE since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

DiviTumTKa is an in vitro diagnostic device intended for the semi-quantitative measurement of thymidine kinase activity (TKa) in human serum. The assay is to be used as an aid in monitoring disease progression in previously diagnosed hormone receptor positive, metastatic postmenopausal female breast cancer patients. A TKa value of <250 DuA is associated with the decreased likelihood of disease progression within 30 days or 60 days post testing. DiviTumTKa results should be used in conjunction with other clinical methods for monitoring breast cancer.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K202852 · printed Nov 5, 2026

Cite this page

510(k) Report. “K202852: DiviTum TKa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202852

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