# K150063: One Step hCG Pregnancy Test

- Pathway: 510(k) (Traditional)
- Applicant: Coretests, Inc.
- Decided: Oct 2, 2015 after 262 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
Longest line of descent: 4 generations back to K941090 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043443: One Step HCG Urine Pregnancy Test, Guangzhou Wondfo Biotech Co., Ltd. (2005) Summary page 4.

## Most influential descendants
- K230741: Macro & Micro-Test HCG Pregnancy Test Midstream (2023), 0 descendants of its own

## Indications for use
ACCU NEWS One Step Pregnancy Test Strip: The ACCU NEWS One Step Pregnancy Test Strip is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy Test Cassette: The ACCU NEWS One Step Pregnancy Test Cassette is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use. ACCU NEWS One Step Pregnancy Test Midstream: The ACCU NEWS One Step Pregnancy Test Midstream is a lateral flow immunoassay to qualitatively detect the presence of human Chorionic Gonadotropin (hCG) hormone in urine specimen to aid early detection of pregnancy for both prescription use and OTC use.

Source page: https://510kreport.com/device/K150063
Methodology: https://510kreport.com/methodology