# K980173: Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Mar 18, 1998 after 57 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACS:180 Total hCG B+: named in the summary without a submission number

## Most influential descendants
- K023480: Access Total BHCG (2002), 0 descendants of its own

## Recalls of this device
- Oct 20, 2010 · Not classified · Z-1736-2011: Beckman Coulter has confirmed that non-reproducible falsely elevated test results may occur when using the Access Total BhCG assay. These elevated results are often attributed to pre-analytical factor

## Indications for use
The ACCESS® Total BhCG assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of total BhCG in human serum, using the the ACCESS® Immunoassay System.

Source page: https://510kreport.com/device/K980173
Methodology: https://510kreport.com/methodology