# K020438: Sas Value HCG

- Pathway: 510(k) (Abbreviated)
- Applicant: Sa Scientific, Inc.
- Decided: Mar 8, 2002 after 25 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
SAS™ Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy. The test is for professional use.

Source page: https://510kreport.com/device/K020438
Methodology: https://510kreport.com/methodology