# K221990: Access Total ßhCG (5th IS)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 27, 2022 after 174 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)
- K130020: Access Total BHCG (5TH IS), Beckman Coulter, Inc. (2013) Summary page 4.

## Indications for use
The Access Total βhCG (5th IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total βhCG levels in human serum and plasma using the Access Immunoassay Systems. This assay is intended for use as an aid in the early detection of pregnancy.

Source page: https://510kreport.com/device/K221990
Methodology: https://510kreport.com/methodology