# K991067: Modification of: Davidstrip HCG

- Pathway: 510(k) (Traditional)
- Applicant: Simex Medical, Inc.
- Decided: Apr 27, 1999 after 28 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
DavidStrip hCG is a qualitative, two site sandwich immunoassay test kit for the rapid determination of hCG concentration in urine for the early detection of pregnancy. This test kit is used to obtain a visual and qualitative result and is for professional use only.

Source page: https://510kreport.com/device/K991067
Methodology: https://510kreport.com/methodology