# K172322: Atellica IM Total hCG (ThCG)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Mar 29, 2018 after 240 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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 K925277 (1993). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925277: Ciba Corning Acs HCG Immunoassay, Ciba Corning Diagnostics Corp. (1993) Summary page 4.

## Most influential descendants
- K200210: ADVIA Centaur® Total hCG assay (2021), 0 descendants of its own
- K192790: Atellica IM Total hCG (ThCG) (2019), 0 descendants of its own

## 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 using the Atellica IM Analyzer. The Atellica IM ThCG assay is intended for use as an aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K172322
Methodology: https://510kreport.com/methodology