# K043385: Osom HCG Combo Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics
- Decided: Apr 12, 2005 after 124 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 QuickVue®+ One-Step hCG Combo Test: named in the summary without a submission number

## Indications for use
The OSOM hCG Combo test is a rapid immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine or serum as an aid in the early detection of pregnancy. This test is for use in physicians' offices and clinical laboratories.

Source page: https://510kreport.com/device/K043385
Methodology: https://510kreport.com/methodology