# K973352: Brand Name *1-Step Pregnancy

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Oct 27, 1997 after 52 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) First Response® 1-Step Pregnancy Test: named in the summary without a submission number

## Indications for use
The Brand Name 1-Step Pregnancy Test is an at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The Brand Name 1-Step Pregnancy Test detects the presence of hCG in the urine as an aid in the early diagnosis of pregnancy. The test, which can be used anytime of the day, can detect hCG as early as the first day of the missed menses.

Source page: https://510kreport.com/device/K973352
Methodology: https://510kreport.com/methodology