# K964020: Axsym CA 125

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 4, 1997 after 393 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- 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.
9 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)
- None. The FDA summary names its predicate without a number.
- (no number) ABBOTT CA 125 II™ RIA assay: named in the summary without a submission number

## Most influential descendants
- K042731: Architect CA 125 II Assay (2004), 8 descendants of its own
- 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

## Recalls of this device
- Apr 23, 2007 · Not classified · Z-1026-2007: 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
- Nov 25, 2003 · Not classified · Z-0318-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto
- Nov 25, 2003 · Not classified · Z-0320-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto
- Nov 25, 2003 · Not classified · Z-0321-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto

## Indications for use
The AxSYM® CA 125™ assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of CA 125 assay values in human serum. The AxSYM® CA 125™ 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 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Source page: https://510kreport.com/device/K964020
Methodology: https://510kreport.com/methodology