# K990578: Osom Card II HCG-Urine Test, Model 102

- Pathway: 510(k) (Traditional)
- Applicant: Wyntek Diagnostics, Inc.
- Decided: Mar 9, 1999 after 14 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Abbott TestPack Plus hCG Urine Test: named in the summary without a submission number
- (no number) Wyntek's OSOM® Classic hCG-Urine Test: named in the summary without a submission number

## Most influential descendants
- K131931: Chemtrue (R) HCG Pregnancy Urine Midstream Test (2013), 0 descendants of its own
- K123844: Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test,  and HCG Combo Serum/Urine Cassette Test (2013), 0 descendants of its own

## Indications for use
The OSOM® Card Il 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/K990578
Methodology: https://510kreport.com/methodology