Aware Test System
by American Drug Screens, Inc.
PMA P900042
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP900042 | Date18 Jan 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- TEST SYSTEM, FOR DRUGS OF ABUSE
- PMA Number
- FDA Product Code
- MGX
- Device Class
- Class III
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Aware Test System is a Test System, For Drugs of Abuse (Device Class III), designed for the qualitative detection of drugs of abuse in biological specimens. It employs immunoassay technology to identify multiple controlled substances, aiding clinical chemistry applications in screening for substance use.
This system is supplied as a single-use device, intended for use in clinical laboratories and regulated settings. It requires no special storage conditions beyond those specified in the manufacturer’s instructions and is approved under FDA_PMA (P900042). Compliance with MGX product code classifications ensures adherence to regulatory standards for drug testing systems.
Questions
AI-generated answers, 18 Sep 2026
What types of biological specimens can the Aware Test System detect drugs of abuse in, and how does it work?
The Aware Test System is designed for **qualitative detection of drugs of abuse in biological specimens**, specifically using **immunoassay technology**. While the exact specimen types (e.g., urine, saliva, blood) aren’t detailed in the data, this system is intended for clinical chemistry applications in regulated settings like laboratories. Immunoassays work by using antibodies to bind to specific drug molecules, triggering a detectable signal to confirm their presence.
Is the Aware Test System reusable, or does it require disposal after each use?
The Aware Test System is explicitly labeled as a **single-use device**, meaning each test kit is intended for one use only. This design minimizes cross-contamination risks and ensures accurate results, as reuse could compromise sterility or performance. Always follow the manufacturer’s instructions for proper disposal.
What storage conditions are required for the Aware Test System, and can it be stored at room temperature?
The Aware Test System does **not** require special storage conditions beyond what the manufacturer specifies in its instructions. While the data doesn’t detail exact temperature or humidity requirements, the lack of mention of refrigeration or controlled environments implies it can likely be stored at **room temperature**—though verifying the included instructions is critical for compliance and efficacy.
How was the Aware Test System approved by the FDA, and what regulatory pathway did it follow?
The Aware Test System received **FDA approval via a Premarket Approval (PMA)** under the designation **P900042**, a rigorous process for **Class III devices** like drug testing systems. This pathway ensures the device meets strict safety and effectiveness standards before market authorization. The approval was finalized on **January 18, 1994**, after review by the **Clinical Chemistry (CH) Advisory Committee**.
Are there different sizes or models of the Aware Test System, or is it available in a single configuration?
The provided data does not specify **multiple sizes or models** of the Aware Test System. It is described generically as a **Test System for Drugs of Abuse**, implying a standardized configuration for qualitative immunoassay testing. For variations (e.g., test panels or formats), you would need to consult the manufacturer’s catalog or instructions, as no distinctions are noted in the regulatory filings.