# K970082: Abbott Advisor One-Step Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 24, 1997 after 15 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
Longest line of descent: 1 generation back to K962521 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962521: Factplus One Step Pregnancy Test, Direct Access Diagnostics (1996) Summary page 2.

## Indications for use
The ABBOTT Advisor One-Step Pregnancy Test is an over-the counter in vitro test which can be used by the consumer to detect pregnancy as early as the first day of her missed period, using a direct urine stream sampling method. Some positive results appear as soon as three minutes, however, all results are confirmed when the Test Timer turns pink/red. The Test Timer will turn pink/red approximately 5 minutes after the urine has been added to the test device.

Source page: https://510kreport.com/device/K970082
Methodology: https://510kreport.com/methodology