# K023480: Access Total BHCG

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 20, 2002 after 64 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K980173 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980173: Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505, Beckman Instruments, Inc. (1998) Summary page 1.

## Recalls of this device
- Mar 5, 2009 · Not classified · Z-0050-2012: The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecisio

## Indications for use
The Access Total PhCG assay provides in vitro quantitative determination of total βhCG levels in human serum and plasma. The Access Total PhCG assay is indicated for use with patients where an early detection of pregnancy status is desired.

Source page: https://510kreport.com/device/K023480
Methodology: https://510kreport.com/methodology