At Home Drug Test, Model 9084
by Phamatech, Inc. 510(k)
Active
510(k) K013407
Overview
The At Home Drug Test, Model 9084 is an enzyme immunoassay device designed for the qualitative detection of opiates in urine. It employs lateral flow technology with a visual color sandwich immunochemical method, where specific antibody-target drug-antibody complexes form on a test strip to indicate the presence of opiates.
This single-use, non-sterile device is intended for home use and requires no specialized equipment beyond the test strip itself. It is classified as a Class II medical device under FDA regulations (862.3650) and received a 510(k) clearance (K013407) as substantially equivalent to a predicate device. The device is supplied as a ready-to-use kit and is regulated under the Clinical Toxicology specialty category.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013407 | Date6 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DJG
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3650
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Phamatech Inc.
Questions
What is the At Home Drug Test, Model 9084 used for?
The At Home Drug Test, Model 9084 is designed for the qualitative detection of opiates in urine samples. It uses lateral flow technology with a visual color sandwich immunochemical method to identify the presence of opiates, making it suitable for home testing without requiring specialized equipment.
How is the At Home Drug Test, Model 9084 supplied?
This device is supplied as a ready-to-use kit. Each kit contains a single-use test strip, which is the only equipment needed to perform the test. The kit is non-sterile and intended exclusively for home use.
Is the At Home Drug Test, Model 9084 sterile?
No, the At Home Drug Test, Model 9084 is explicitly labeled as non-sterile. Since it is intended for home use and designed as a single-use device, sterility is not required for its intended purpose.
Can the At Home Drug Test, Model 9084 be reused?
No, the At Home Drug Test, Model 9084 is a single-use device. Each test strip is intended for one-time use only, ensuring accurate and reliable results for the specific urine sample being tested.
What regulatory pathway does the At Home Drug Test, Model 9084 follow?
The At Home Drug Test, Model 9084 is classified as a Class II medical device under FDA regulations (862.3650) and received a 510(k) clearance (K013407). It is regulated under the Clinical Toxicology specialty category and is considered substantially equivalent to a predicate device.