# K062703: One Step HCG Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Ai DE Diagnostic Co., Ltd.
- Decided: Jul 23, 2007 after 315 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
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. The FDA summary names no predicate by number.

## Indications for use
One Step HCG Urine Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in the formats of strip, cassette and midstream. The midstream format is intended for OTC use. The cassette and strip format are intended for both over-the counter (OTC) use and use in clinical laboratories. One Step HCG Serum/Urine Combo Pregnancy Test is a rapid device, two sites sandwich immunoassay test device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine or serum samples, and therefore is an aid in the early detection of pregnancy. These test devices are available in strip format and cassette format, and are intended for in vitro diagnostic professional use in clinical laboratories only.

Source page: https://510kreport.com/device/K062703
Methodology: https://510kreport.com/methodology