# K964703: The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System)

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Dec 1, 1997 after 374 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Biomira TRUQUANT® BR™ RIA: named in the summary without a submission number

## Most influential descendants
- K012357: CA 15-3 Assay for the Advia Centaur System (2002), 3 descendants of its own
- K100344: Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605 (2011), 1 descendant of its own
- K013984: Immulite BR-MA, Model #LKBR; Immulite 2000 BR-MA, Model #L2KBR (2002), 1 descendant of its own
- K233946: Immulite® 2000 BR-MA (2024), 0 descendants of its own
- K192777: ADVIA Centaur CA 15-3 assay (2019), 0 descendants of its own

## Indications for use
The Bayer Immuno 1™ CA 15-3™ Assay is an in vitro, diagnostic, solid phase immunoassay intended to quantitatively measure CA 15-3 Assay values in human serum on the Bayer Immuno 1 system. When used in conjunction with other clinical and diagnostic procedures, serial testing with the CA 15-3 Assay is useful for monitoring the course of disease and therapy in metastatic breast cancer patients, and for detection of recurrence in previously treated Stage II, with greater than 2 positive lymph nodes, or Stage III breast cancer patients.

Source page: https://510kreport.com/device/K964703
Methodology: https://510kreport.com/methodology