# K990258: Quantech Total B-HCG Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quantech, Ltd.
- Decided: Dec 21, 1999 after 328 days
- Product code: NAL (Test, Immunoassay, Biosensor, Hcg)
- 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) AxSYM® Total β-hCG assay: named in the summary without a submission number

## Indications for use
The Quantech Total f-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.

Source page: https://510kreport.com/device/K990258
Methodology: https://510kreport.com/methodology