Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen Device
510(k) K121065
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK121065 | Date24 May 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
Overview
AI-generated summary, 1 Oct 2026
The FastEP Dipstick and Dipcard Drugs of Abuse Screen Devices are rapid, qualitative lateral flow chromatographic immunoassays designed for the detection of drugs of abuse in human urine. These devices employ colloidal gold-based technology to identify specific drug analytes at predefined cutoff concentrations, enabling point-of-care screening for substances such as amphetamines, benzodiazepines, cocaine, marijuana, morphine, phencyclidine, and others.
These devices are intended for single-use in clinical toxicology settings, such as emergency departments, forensic laboratories, and addiction treatment centers. Supplied as non-sterile, ready-to-use cassettes, they require no additional preparation beyond urine sample application. The devices are classified under FDA product code DKZ (Enzyme Immunoassay, Amphetamine) and have received FDA 510(k) clearance (K121065) under traditional review. Storage conditions and regulatory compliance align with FDA’s Special Controls for Class II devices under regulation 862.3100.
Other devices from Polymed Therapeutics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the FastEP Dipstick & Dipcard Drugs of Abuse Screen Device used for?
This device is designed for rapid, qualitative detection of drugs of abuse in human urine samples. It uses colloidal gold-based lateral flow immunoassay technology to identify specific drug analytes, such as amphetamines, benzodiazepines, cocaine, marijuana, morphine, and phencyclidine, at predefined cutoff concentrations. It is intended for use in clinical toxicology settings like emergency departments, forensic labs, and addiction treatment centers to enable quick point-of-care screening.
How are the FastEP Dipstick and Dipcard Devices supplied, and do they require preparation?
The FastEP Dipstick and Dipcard Devices are supplied as non-sterile, ready-to-use cassettes. No additional preparation is required beyond applying the urine sample directly to the device. They are designed for single-use only, ensuring each test is accurate and uncontaminated.
Are the FastEP Devices single-use or reusable?
The FastEP Dipstick and Dipcard Devices are explicitly designed for single-use only. This ensures reliability and prevents cross-contamination between tests, which is critical for accurate drug screening in clinical settings.
What storage conditions should be followed for these devices?
While the exact storage conditions are not detailed in the provided data, the device complies with FDA’s Special Controls for Class II devices under regulation 862.3100. Generally, such lateral flow devices should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage guidelines.
What regulatory approvals apply to the FastEP Dipstick and Dipcard Devices?
The FastEP Dipstick and Dipcard Drugs of Abuse Screen Devices have received FDA 510(k) clearance (K121065) under traditional review. They are classified under FDA product code DKZ (Enzyme Immunoassay, Amphetamine) and are intended for use in clinical toxicology settings as specified by the manufacturer.