# K974615: Quickstick Pro HCG Test

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Jan 26, 1998 after 46 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) Unipath Clearview HCG: named in the summary without a submission number
- (no number) Abbott Laboratories’ Fact Plus: named in the summary without a submission number
- (no number) Syntron Bioresearch Be Sure Pregnancy Test: named in the summary without a submission number

## Indications for use
This test detects hCG in urine. hCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. This device is intended for clinical laboratories (labs) and physician's office labs (POLs) as an IVD test for the qualitative measurement of hCG in urine.” Clinical labs can include hosptials and reference labs. POLs can include mini-clinics.

Source page: https://510kreport.com/device/K974615
Methodology: https://510kreport.com/methodology