# K192790: Atellica IM Total hCG (ThCG)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 30, 2019 after 30 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
The Atellica® IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer. Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K192790
Methodology: https://510kreport.com/methodology