# K955707: Onestep Urine/Serum HCG Module Pregnancy Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Excel Scientific, Inc.
- Decided: May 2, 1996 after 139 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Syntron Quikpac I enzyme immunoassay: named in the summary without a submission number

## Indications for use
Excel OneStep Urine/Serum hCG Module Pregnancy Test is Excel Scientific, inc.'s name for the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum.

Source page: https://510kreport.com/device/K955707
Methodology: https://510kreport.com/methodology