# K983113: Besure Plus One-Step Home Ovulation Predictor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Syntron Bioresearch, Inc.
- Decided: Nov 18, 1998 after 75 days
- Product code: CEP (Radioimmunoassay, Luteinizing Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1485
- 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 K951538 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951538: Besure One-=Step Home Ovulation Predictor Kit, Syntron Bioresearch, Inc. (1995) Summary page 1.

## Most influential descendants
- K994035: Immunodip Urinary Albumin Screen, Model 790-01, 790-15 (2000), 0 descendants of its own

## Indications for use
BeSure Plus OneStep Ovulation Home predicator test is a solid phase immunoassay in vitro diagnostic test kit. It is intended for over the counter use for the qualitative determination of leutinizing hormone (LH) in urine. This test kit is utilized to determine when the female body will ovulate, the most likely time for conception to occur.

Source page: https://510kreport.com/device/K983113
Methodology: https://510kreport.com/methodology