# K042731: Architect CA 125 II Assay

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Nov 19, 2004 after 49 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964020 (1997). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964020: Axsym CA 125, Abbott Laboratories (1997) Summary page 3.

## Most influential descendants
- K072939: HE4 Eia, Model: 404-10 US (2008), 7 descendants of its own
- K093957: Architect HE4, Architect HE4 Calibrators and Architect HE4 Controls, Models 2, 2P54, 2P54-01, 2P54-10 SP54-01, (2010), 4 descendants of its own
- K112624: Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4, Elecsys HE4 Calcheck 5 (2012), 2 descendants of its own
- K160915: Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker (2016), 1 descendant of its own
- K250925: ADVIA Centaur Cytokeratin Fragment 21-1 (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K042731
Methodology: https://510kreport.com/methodology