# K131037: Liaison XL HCG

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Sep 6, 2013 after 144 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- 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 K003178 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003178: Elecsys HCG and Beta Test System, Roche Diagnostics Corp. (2000) Summary page 1.

## Indications for use
The DiaSorin LIAISON® XL HOG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® XL Analyzer for the quantitative determination of total human chorionic gonadotropin (hCG and JOhCG) in human serum for early detection of pregnancy. Total hCG is the measurement of intact and beta-hOG.

Source page: https://510kreport.com/device/K131037
Methodology: https://510kreport.com/methodology