# K925277: Ciba Corning Acs HCG Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Mar 19, 1993 after 150 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K172322: Atellica IM Total hCG (ThCG) (2018), 2 descendants of its own
- K130020: Access Total BHCG (5TH IS) (2013), 2 descendants of its own
- K221990: Access Total ßhCG (5th IS) (2022), 0 descendants of its own
- K200210: ADVIA Centaur® Total hCG assay (2021), 0 descendants of its own
- K192547: Maglumi  2000 HCG/ß-HCG (2020), 0 descendants of its own

Source page: https://510kreport.com/device/K925277
Methodology: https://510kreport.com/methodology