# K032987: Accutest HCG-Combo Model,HCG-004, Accustrip HCG-Combo Model, HCG-005

- Pathway: 510(k) (Traditional)
- Applicant: Unotech Diagnostics, Inc.
- Decided: Nov 17, 2003 after 54 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 hCG Combo Test: named in the summary without a submission number

## Indications for use
The intended use of the Unotech Accutest hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy. The intended use of the Unotech Accustrip hCG-Combo is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine or serum for the early detection of pregnancy.

Source page: https://510kreport.com/device/K032987
Methodology: https://510kreport.com/methodology