Multi-Clin Drug Screen Test Device
510(k) K041685
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK041685 | Date30 Aug 2004 | StatusActive |
Official records
- FDA 510(k) database K041685
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Acon Multi-Clin Drug Screen Test Device
- 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, 20 Sep 2026
The Multi-Clin Drug Screen Test Device is an enzyme immunoassay designed for the qualitative and simultaneous detection of multiple drugs in urine specimens. It identifies Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Marijuana, Methylenedioxymethamphetamine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, and Tricyclic Antidepressants. This rapid chromatographic immunoassay provides a rapid, point-of-care testing solution for clinical toxicology applications.
The device is intended for single-use in clinical settings, such as emergency departments, toxicology laboratories, and other healthcare facilities where rapid drug screening is required. Supplied as a ready-to-use kit, it requires no additional preparation beyond standard urine specimen collection. The device has received FDA 510(k) clearance under the classification of Class II medical devices (DKZ), adhering to regulatory standards for enzyme immunoassays. Storage and handling follow standard sterile device protocols, ensuring reliability and accuracy for clinical use.