# K023891: ST Aia-Pack CA 125 Enzyme Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Tosoh Medics, Inc.
- Decided: Dec 6, 2002 after 14 days
- Product code: LTK (Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125))
- 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 K990431 (1999). 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)
- K990431: Aia-Pack CA 125, Tosoh Medics, Inc. (1999) Summary page 1.

## Most influential descendants
- K080561: Vidas CA 125 II Assay (2009), 0 descendants of its own

## Indications for use
ST AIA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST AIA-PACK CA 125 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/K023891
Methodology: https://510kreport.com/methodology