# K973879: Osom Card HCG-Urine Test

- Pathway: 510(k) (Traditional)
- Applicant: Wyntek Diagnostics, Inc.
- Decided: Nov 4, 1997 after 55 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
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) Quidel RapidVue hCG Test: named in the summary without a submission number
- (no number) Abbott TestPack Plus hCG Urine Test: named in the summary without a submission number

## Indications for use
The OSOM™ Card hCG-Urine Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. FOR LABORATORY AND PROFESSIONAL IN VITRO USE ONLY.

Source page: https://510kreport.com/device/K973879
Methodology: https://510kreport.com/methodology