# K963926: Axsym CA 15-3

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Sep 15, 1997 after 350 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 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 Diagnostics Inc. TRUQUANT® BR™ RIA assay: named in the summary without a submission number

## Most influential descendants
- K033036: BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647 (2004), 4 descendants of its own
- K072612: Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647 (2007), 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
- K042732: Architect CA 15-3 Assay (2004), 1 descendant of its own
- K240403: Access BR Monitor (2024), 0 descendants of its own

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-1027-2007: Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instru
- Jun 9, 2006 · Not classified · Z-1244-06: The CA 15-3 Controls replicates out of range high resulting in invalid runs.
- Mar 4, 2003 · Not classified · Z-0679-03: The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
- Mar 4, 2003 · Not classified · Z-0680-03: The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.

## Indications for use
The AxSYM® CA 15-3™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 15-3 assay values in human serum and plasma (EDTA) to aid in the management of 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.

Source page: https://510kreport.com/device/K963926
Methodology: https://510kreport.com/methodology