# K964407: IMX CA 15-3

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 10, 1997 after 371 days
- Product code: MOI (System, Test, Immunological, Antigen, Tumor)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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: named in the summary without a submission number

## Recalls of this device
- 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-0681-03: 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 IMx® 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 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.

Source page: https://510kreport.com/device/K964407
Methodology: https://510kreport.com/methodology