No Step On Site Drug Test Cup
by Drug Free Enterprises 510(k)
Active
510(k) K012390
Overview
The No Step On Site Drug Test Cup is an in vitro diagnostic device designed for the visual qualitative detection of drugs of abuse in human urine. It functions as a specimen collection cup and strip holder that allows for the simultaneous testing of multiple substances.
This device is intended for professional and point-of-care use and is not authorized for over-the-counter sale to lay users. It is regulated under FDA 510(k) clearance K012390.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK012390 | Date18 Dec 2001 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- No Step on Site Deug Test Cup
- 510(k) Number
- FDA Product Code
- LDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3870
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the intended use of the No Step On Site Drug Test Cup?
This device is an in vitro diagnostic tool designed for the visual qualitative detection of drugs of abuse in human urine. It functions as both a specimen collection cup and a strip holder to allow for the simultaneous testing of multiple substances.
Is this device suitable for home or personal use?
No, this device is intended strictly for professional and point-of-care use. It is not authorized for over-the-counter sale to lay users.
What is the regulatory status of this drug test cup?
The No Step On Site Drug Test Cup is regulated under FDA 510(k) clearance K012390, which confirms it has been reviewed and cleared for its intended professional use.