# K200210: ADVIA Centaur® Total hCG assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 13, 2021 after 532 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: 2 generations back to K925277 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172322: Atellica IM Total hCG (ThCG), Siemens Healthcare Diagnostics, Inc. (2018) Summary page 5.

## Indications for use
For in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in serum or plasma (EDTA or lithium heparin) using the ADVIA Centaur® XP system. Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K200210
Methodology: https://510kreport.com/methodology