QuickScreen Amphetamine 500 Test
by Phamatech, Inc. 510(k)
Active
510(k) K131069
Overview
The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic screen that provides a preliminary result for the detection of amphetamine in urine. This device is designed to detect the presence of amphetamine at a specific cut-off concentration.
The test is supplied as a dip card and is intended for single use. It is a Class 2 device that received FDA 510(k) clearance with the K131069 number on May 14, 2014. The device is manufactured by Phamatech, Inc. and is not indicated for MRI use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131069 | Date14 May 2014 | 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- Withdrawn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
- Quickscreen Amphetine 500 Test
- 510(k) Number
- FDA Product Code
- DKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Phamatech Inc.
Questions
What is the QuickScreen Amphetamine 500 Test used for?
The QuickScreen Amphetamine 500 Test is a qualitative in-vitro diagnostic device designed to provide a preliminary result for the detection of amphetamine in urine at a specific cut-off concentration. It is intended for screening purposes only.
How is the QuickScreen Amphetamine 500 Test supplied and is it reusable?
The test is supplied as a dip card and is intended for single use only. After use, the device should be properly disposed of according to local regulations for medical waste. It is not designed for reuse or multiple testing.
What is the regulatory status of the QuickScreen Amphetamine 500 Test?
The QuickScreen Amphetamine 500 Test is a Class 2 medical device that received FDA 510(k) clearance with the K131069 number on May 14, 2014. It is manufactured by Phamatech, Inc. and is not indicated for MRI use.
Are there different sizes or models of the QuickScreen Amphetamine 500 Test available?
The device information provided does not specify multiple sizes or models of the QuickScreen Amphetamine 500 Test. It is described as a dip card format for single-use testing of amphetamine in urine at a specific cut-off concentration.