# K964155: Contrast HCG Urine/Serum Test and Rapid HCG Urine/Serum Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics
- Decided: Nov 25, 1996 after 40 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
Longest line of descent: 1 generation back to K952319 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952319: Contrast & Rapid HCG Urine/Serum TST, Medix Biotech, Inc. (1995) Summary page 1.

## Indications for use
The qualitative detection of human chorionic gonadotropin (hCQG) in urine or serum for the early determination of pregnancy for use in the physician’s office and clinical laboratories.

Source page: https://510kreport.com/device/K964155
Methodology: https://510kreport.com/methodology