# K033297: Zap HCG Test, Model 8001

- Pathway: 510(k) (Traditional)
- Applicant: Zbx Corporation
- Decided: Mar 18, 2004 after 156 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) ICON® II HCG ImmunoConcentration Assay: named in the summary without a submission number

## Indications for use
The ZAPTM hCG Test is an immunoassay used for the qualitative detection of human chorionic gonadotropin in human whole blood (capillary and heparinized venous), plasma, or serum and is indicated as an aid for health care professionals in the diagnosis of early pregnancy.

Source page: https://510kreport.com/device/K033297
Methodology: https://510kreport.com/methodology