# K992695: Insure Pro Test

- Pathway: 510(k) (Traditional)
- Applicant: Inbios Intl., Inc.
- Decided: Oct 18, 1999 after 68 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Insure Pro Test is intended for the qualitative detection of human chorionic gonadotropin (hCG) in urine for the detection of early pregnancy. This test is intended for laboratory or professional use only.

Source page: https://510kreport.com/device/K992695
Methodology: https://510kreport.com/methodology