# K991515: Insure Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Inbios Intl., Inc.
- Decided: May 28, 1999 after 28 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- 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 Pregnancy 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/K991515
Methodology: https://510kreport.com/methodology