# K962521: Factplus One Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Direct Access Diagnostics
- Decided: Jul 29, 1996 after 40 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) ADVANCE® Pregnancy Test: named in the summary without a submission number

## Most influential descendants
- K970082: Abbott Advisor One-Step Pregnancy Test (1997), 0 descendants of its own

## Indications for use
FactPLiJS Cne Step Pregnancy Test is indicated for consumer use to detect pregnancy as early as first day of 2 missed period, using a direct urine stream sampling mode. Test results can be read after three minutes. Some positives appear as soon as one minute, negative results are confirmed in three minutes.

Source page: https://510kreport.com/device/K962521
Methodology: https://510kreport.com/methodology