# K973570: Quick Card HCG One Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Oct 31, 1997 after 42 days
- Product code: LCX (Kit, Test, Pregnancy, Hcg, Over The Counter)
- 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) Abbot 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
An hCG pregnancy test intended for over the counter use by lay persons is an in vitro diagnostic test for the qualitative identification of human Chorionic Gonadotropin (HCG), a human hormone, in urine. Measurements that are obtained by this device are used in the diagnosis of pregnancy.

Source page: https://510kreport.com/device/K973570
Methodology: https://510kreport.com/methodology