510(k) · Cleared
ClearedArchitect CA 125 II Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujirebio Diagnostics,Inc. · LTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Cleared on Nov 19, 2004 as substantially equivalent to K964020 (Abbott Laboratories, 1997) after a 49-day review. Its family tree reaches back 1 generation to 1997. 8 later devices descend from it.
- Decided
- Nov 19, 2004
- Review
- 49 days
- Class
- Class II
- Product code
- LTK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964020 (1997). 8 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964020 Axsym CA 125Abbott Laboratories · 1997 · Recalled
- This deviceK042731 Architect CA 125 II AssayFujirebio Diagnostics,Inc. · 2004
- Descendant · cites it directly · 7 of its ownK072939 HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008
- Descendant · 2 generations on · 4 of its ownK093957 Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls…Fujirebio Diagnostics,Inc. · 2010
- Descendant · 3 generations on · 2 of its ownK112624 Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys…Roche Diagnostics · 2012
- Descendant · 4 generations on · 1 of its ownK160915 Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor…Roche Diagnostics · 2016
- Descendant · 5 generations on · 0 of its ownK250925 ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K072939HE4 Eia, Model: 404-10 USFujirebio Diagnostics,Inc. · 2008 · cites it directly7descendants
- K093957Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54…Fujirebio Diagnostics,Inc. · 2010 · 2 generations on4descendants
- K112624Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5Roche Diagnostics · 2012 · 3 generations on2descendants
- K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics · 2016 · 4 generations on1descendant
- K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964020 | Axsym CA 125 | Abbott Laboratories | 1997 | 4 |
| 0 (this device) | K042731 | Architect CA 125 II Assay | Fujirebio Diagnostics,Inc. | 2004 | — |
| +1 | 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 | — |
| +3 | K112624 | Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4… | Roche Diagnostics | 2012 | — |
| +4 | K160915 | Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker | Roche Diagnostics | 2016 | — |
| +5 | K250925 | ADVIA Centaur Cytokeratin Fragment 21-1 | Fujirebio Diagnostics,Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 LTK? 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 LTK device
- #1 K240479 Access OV Monitorscore 7.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K964020 | Axsym CA 125Summary page 3…(Proposed Device) (Predicate Device) K964020 Device Type In vitro diagnostic In vitro diagnostic Classification and Class II,LTK… | 1997 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072939 | HE4 Eia, Model: 404-10 US | 2008 | 7 |
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?
- Its one ancestor has a recall.
- Of its descendants, K072939 (Fujirebio Diagnostics,Inc., 2008) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LTK devicesLTK Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LTK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LTK
Too few LTK 510(k)s in any year since 2007 to give a median.
Recalls per year · LTK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTK
4in 2025
MAUDE reports naming product code LTK, 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 | 1 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 9 |
| 2009 | 2 | — | 0 | 31 |
| 2010 | 0 | — | 3 | 12 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 33 |
| 2013 | 0 | — | 1 | 14 |
| 2014 | 0 | — | 0 | 30 |
| 2015 | 2 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ARCHITECT CA 125 II assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CA 125 reactive determinants in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 II assay values should be used in conjunction with other clinical methods used for…
Read the full statement (171 words)
The ARCHITECT CA 125 II assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of CA 125 reactive determinants in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 II assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.
The ARCHITECT CA 125 II Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of OC 125 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 125 II reagent package insert for additional information.
The ARCHITECT CA 125 II Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of OC 125 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 125 II reagent package insert for additional information.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042731: Architect CA 125 II Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042731
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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