# K980205: San Diego Biotech HCG Pregnancy Dipstick Test

- Pathway: 510(k) (Traditional)
- Applicant: San Diego Biotech
- Decided: Feb 12, 1998 after 23 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The San Diego Biotech HCG Pregnancy Dipstick Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. This test is intended for professional and Laboratory use only.

Source page: https://510kreport.com/device/K980205
Methodology: https://510kreport.com/methodology