# K041728: HCG Detector Combi, HCG Detector Stix, HCG Detector Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Immunostics Inc.,
- Decided: Aug 11, 2004 after 47 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
The Immuno / hCG DetectorTM - Urine is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only. The Immuno / hCG Detector Stix is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only. The Immuno / hCG Detector CombiTM is for the rapid and qualitative determination of Human Chorionic gonadotropin (hCG) in urine or serum as an aid for the early detection of pregnancy. It is intended for professional and laboratory use only.

Source page: https://510kreport.com/device/K041728
Methodology: https://510kreport.com/methodology