Dr. Brown's Home Drug Testing Kit
by Personal Health & Hygiene, Inc.
PMA P950040
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP950040 | Date21 Jan 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Generic Name
- Enzyme immunoassay, cannabinoids
- PMA Number
- FDA Product Code
- LDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3870
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
This device is an enzyme immunoassay for cannabinoids, designed to detect the presence of cannabinoid metabolites in urine samples. It functions as a rapid, qualitative test to screen for drug use, providing results within minutes without requiring laboratory processing.
The kit is intended for home use and is supplied as a single-use, non-sterile diagnostic tool. It is classified as a Class II medical device under FDA regulations and requires approval for labeling. No MRI safety information is provided, and the device must be stored according to manufacturer instructions to maintain its integrity until use.
Questions
AI-generated answers, 18 Sep 2026
What is the DR. BROWN'S HOME DRUG TESTING KIT used for and how does it work?
The DR. BROWN'S HOME DRUG TESTING KIT is an enzyme immunoassay designed to detect cannabinoid metabolites in urine samples, serving as a rapid, qualitative screening tool for drug use. It provides results within minutes without needing lab processing, making it ideal for home use to screen for recent cannabinoid exposure.
Is this device intended for single-use or can it be reused?
The DR. BROWN'S HOME DRUG TESTING KIT is explicitly labeled as a single-use device. Reuse is not recommended or supported by the manufacturer, as it could compromise accuracy and reliability.
How should I store the DR. BROWN'S HOME DRUG TESTING KIT before use?
The kit must be stored according to the manufacturer’s instructions to maintain its integrity until use. Since it is non-sterile and intended for home use, storage conditions likely include protection from extreme temperatures, moisture, and direct sunlight, though exact details are not specified in the provided data.
What regulatory approval does this device have, and how does that affect its use?
The DR. BROWN'S HOME DRUG TESTING KIT holds an FDA Premarket Approval (PMA) under PMA number P950040, confirming it meets regulatory standards for Class II medical devices. This approval ensures the device’s labeling and intended use comply with FDA requirements, but it does not imply clinical efficacy or diagnostic accuracy beyond its specified purpose—qualitative screening for cannabinoid metabolites.
Can this kit be used in professional or clinical settings, or is it strictly for home use?
The device is explicitly designed for home use and is not marketed or approved for professional or clinical settings. While it may be used in non-laboratory environments like schools or workplaces, its regulatory classification and labeling emphasize its role as a consumer-grade screening tool, not a definitive diagnostic tool.