# K990684: Modification of Sas Serum/Urine HCG

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Inc.
- Decided: May 10, 1999 after 68 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™ Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in serum or urine to aid in the early detection of pregnancy. This test is for professional use only.

Source page: https://510kreport.com/device/K990684
Methodology: https://510kreport.com/methodology