Emit D.A.U. Monoclonal Amphetamine/Methamphetamine
by Syva Co. 510(k)
Active
510(k) K894404
Overview
The EMIT D.A.U. Monoclonal Amphetamine/Methamphetamine Assay is an enzyme immunoassay designed for the qualitative detection of amphetamine and methamphetamine in urine and plasma. It employs monoclonal antibodies to selectively identify S(+)-methamphetamine and S(+)-amphetamine, enabling rapid screening for drug use or overdose in clinical toxicology settings.
This device is intended for single-use in laboratory settings and requires no sterilisation beyond standard reagent preparation. It operates under FDA 510(k) clearance (K894404) as a Class II medical device, with a defined cut-off of 1000 ng/mL for methamphetamine and approximately 400 ng/mL for amphetamine. Supplied as a reagent kit, it must be stored according to manufacturer instructions and used within specified expiration dates.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894404 | Date11 Aug 1989 | 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- Withdrawn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
- DKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3100
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What types of samples can the EMIT D.A.U. Monoclonal Amphetamine/Methamphetamine Assay test for amphetamine and methamphetamine use or exposure?
This assay is specifically designed for qualitative detection of amphetamine and methamphetamine in urine and plasma samples. It uses monoclonal antibodies to target S(+)-methamphetamine and S(+)-amphetamine, making it suitable for clinical toxicology applications like screening for drug use or overdose.
Is this device intended for single-use or repeated use in a laboratory setting?
The EMIT D.A.U. Monoclonal Amphetamine/Methamphetamine Assay is intended for single-use only in laboratory settings. It does not require sterilization beyond standard reagent preparation, as it is not implanted or used in direct patient contact.
What are the defined cut-off levels for methamphetamine and amphetamine in this assay?
The assay has a cut-off of 1000 ng/mL for methamphetamine and approximately 400 ng/mL for amphetamine. These thresholds determine the minimum concentration at which the device will yield a positive result for qualitative detection.
How should the reagent kit be stored, and what are the key considerations for its use?
The reagent kit must be stored according to the manufacturer’s instructions, including adherence to expiration dates. Since it is a single-use enzyme immunoassay, proper storage ensures reagent stability and accuracy of results. Always follow the provided guidelines to maintain integrity until use.
What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?
The EMIT D.A.U. Monoclonal Amphetamine/Methamphetamine Assay was cleared through the FDA 510(k) pathway under the classification of a Class II medical device. The clearance (K894404) was granted in 1989, and it falls under the Clinical Toxicology advisory committee category.