# K981838: Accustrip HCG-Urine Model Number HCG-002

- Pathway: 510(k) (Traditional)
- Applicant: Unotech Diagnostics, Inc.
- Decided: Jun 25, 1998 after 30 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) AccuTest™ hCG-Urine: named in the summary without a submission number

## Indications for use
The intended use of the Unotech AccuStrip hCG-Urine is for the qualitative determination of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy We intend to market this product to physicians' office laboratories and clinical laboratories in the U.S.A. as well as in the foreign countries.

Source page: https://510kreport.com/device/K981838
Methodology: https://510kreport.com/methodology