# K022683: Sas Blood/Serum/Urine/Urine HCG

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Inc.
- Decided: Dec 16, 2002 after 126 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) Modified SAS Serum/Urine hCG Test: named in the summary without a submission number

## Indications for use
SASTMBlood/Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in whole blood, serum or urine to aid in the early detection of pregnancy. The test is for professional use.

Source page: https://510kreport.com/device/K022683
Methodology: https://510kreport.com/methodology