# K994227: Advantage HCG Test (Urine/Serum)

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Diagnostics Corp.
- Decided: Feb 3, 2000 after 50 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) PS-Unit Cassette/Serum and Urine Combo HCG: named in the summary without a submission number

## Indications for use
The Advantage hCG Test (Urine/Serum) is a qualitative, rapid immunochromatographic assay used to detect the presence of hCG in human urine and serum for the early detection of pregnancy. The test is intended for use in clinical laboratories by health care professionals.

Source page: https://510kreport.com/device/K994227
Methodology: https://510kreport.com/methodology