# K130020: Access Total BHCG (5TH IS)

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Oct 1, 2013 after 271 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: 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 1.

## Most influential descendants
- K221990: Access Total ßhCG (5th IS) (2022), 0 descendants of its own
- K192547: Maglumi  2000 HCG/ß-HCG (2020), 0 descendants of its own

## Indications for use
The Access Total [IhCG (5h IS)assay is aparamagnetic particle, chemi luminescent immunoassay for the quantitative determination of total PhCG levels in human serum and plasma using the Access Inmmunoassay Systems. The assay is intended for use as an aid in the early detection of pregnancy. The Access Total PhCG (5th IS)calibrators air intended to calibrate the Access Total PhCG (5h' IS) assay for the quantitative determination of total IPhCG levels in human serum and plasma using the Access Immunoassay Systems.

Source page: https://510kreport.com/device/K130020
Methodology: https://510kreport.com/methodology