# K023544: Genzyme Contrast II HCG Urine/Serum Test

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jan 16, 2003 after 86 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 K020801 (2002). 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)
- K020801: Quickvue One-Step HCG-Combo, Quidel Corp. (2002). Our reading of the summary gave K020881, FDA’s number for Modification to Personal Infusor Local Pain Management… (Science Incorporated). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Quidel QuickVue One-Step hCG Combo Test”.

## Indications for use
The Contrast II hCG Urine/Serum Test system is intended for the qualitative detection of human chorionic gonadotropin (hCG), a placental hormone, in urine or serum for the early detection of pregnancy. The test is intended for use by health care professionals.

Source page: https://510kreport.com/device/K023544
Methodology: https://510kreport.com/methodology