# K962183: Brand Name 1-Step Pregnancy Test-May BE Marketed Under First Response, Answer, or Other Brand Names

- Pathway: 510(k) (Traditional)
- Applicant: Armkel, LLC
- Decided: Jul 10, 1996 after 34 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) One-Step CLEARBLUE Easy™ Pregnancy Test: named in the summary without a submission number

## Indications for use
The Brand Name 1-Step Pregnancy Test is a simple-to-use at-home pregnancy test marketed over-the-counter (OTC) to lay consumers. The test device product is intended for the detection of human chorionic gonadotropin (hCG) in urine as an aid in the detection of early pregnancy.

Source page: https://510kreport.com/device/K962183
Methodology: https://510kreport.com/methodology