# K972682: Quickstick One Step HCG Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Aug 1, 1997 after 15 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) 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
Over-the-Counter HCG (pregnancy) tests are for utlmgg“ipdividuals who, for any reason, beliave they may be pregnant. This tesLdetects‘hCG inurine. 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. Early identification is important in the management of pregnancy. This condition must be identified so that fetal exposure to potentially harmful circumstance may be minimized or eliminated. Many individuals hesitate to seek clinical confirmation of this condition (pregnancy) due to medical examination costs and appointmeant scheduling difficuities. This device offers an altemative to the initial office visit and will allow for more rapid initiation of pre-natal care upon confimation tests by trained clinicat technicians.

Source page: https://510kreport.com/device/K972682
Methodology: https://510kreport.com/methodology