# K962906: Scripps Laboratories  HCG One-Step

- Pathway: 510(k) (Traditional)
- Applicant: Scripps Laboratories, Inc.
- Decided: Aug 23, 1996 after 29 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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 K925435 (1992). 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)
- K925435: Quickvue One-Step HCG Test, Quidel Corp. (1992) Summary page 2.
- K953383: Wyntek Osom HCG-Urine Test, Wyntek Diagnostics, Inc. (1995) Summary page 2.

## Indications for use
Scripps Laboratories hCG One-Step is a rapid, one step immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the early detection of pregnancy. For Laboratory and Professional Use.

Source page: https://510kreport.com/device/K962906
Methodology: https://510kreport.com/methodology