# K990373: Fact Plus One Step Pregnancy Test

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Feb 22, 1999 after 14 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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K970470: Evt Expandable Sheath, Guidant Cardiac and Vascular Surgery (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Fact plus® One Step Pregnancy Test is a qualitative, consumer home-use, in vitro diagnostic immunoassay for the detection of human chorionic gonadotropin (hCG) in human urine for the early detection of pregnancy.

Source page: https://510kreport.com/device/K990373
Methodology: https://510kreport.com/methodology