# K981512: Icon Fxhcg Urine/Serum Test, Icon Fxhcg Urine Test, Models 40025,40050, 40005 & 41025

- Pathway: 510(k) (Traditional)
- Applicant: Skd, Inc. A Beckman Coulter Co.
- Decided: May 28, 1998 after 30 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 ICON® F, hCG test is a rapid qualitative test designed to detect human chorionic gonadotropin (hCG) in urine or serum, as an aid in the early detection of pregnancy. The ICON® Fy hCG test is for professional use.

Source page: https://510kreport.com/device/K981512
Methodology: https://510kreport.com/methodology