# K962888: Affirm One-Step Home Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Athena Medical Corp.
- Decided: Sep 23, 1996 after 61 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) OneStep Be Sure® Plus Midstream Pregnancy Home Test: named in the summary without a submission number
- (no number) Be Sure® Plus: named in the summary without a submission number

## Indications for use
Affirm One-Step home pregnancy test is a rapid one-step visual test for the qualitative detection of human chorionic gonadotropin in human urine to aid in the diagnosis of pregnancy. This test is intended for over-the-counter home use.

Source page: https://510kreport.com/device/K962888
Methodology: https://510kreport.com/methodology