# K042732: Architect CA 15-3 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Fujirebio Diagnostics,Inc.
- Decided: Dec 22, 2004 after 82 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- 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 K963926 (1997). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963926: Axsym CA 15-3, Abbott Laboratories (1997) Summary page 3.

## Most influential descendants
- K192524: Lumipulse G CA15-3 (2020), 0 descendants of its own

## Indications for use
The ARCHITECT CA 15-3 assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of DF3 defined antigen in human serum and plasma on the ARCHITECT i System. The ARCHITECT CA 15-3 assay is to be used as an aid in the management of Stage II and III breast cancer patients. Serial testing for patient CA 15-3 assay values should be used in conjunction with other clinical methods for monitoring breast cancer. The ARCHITECT CA 15-3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information. The ARCHITECT CA 15-3 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of DF3 defined antigen in human serum and plasma. Refer to the ARCHITECT CA 15-3 reagent package insert for additional information.

Source page: https://510kreport.com/device/K042732
Methodology: https://510kreport.com/methodology