Syva EMIT II Plus Amphetamine/Methamphetamine Assay 9C029UL/9C129UL
by Syva Co. 510(k)
Active
510(k) K993982
Overview
The Syva EMIT II Plus Amphetamine/Methamphetamine Assay is a homogeneous enzyme immunoassay designed for the qualitative and semiquantitative detection of amphetamines and methamphetamines in human urine. It employs enzyme-linked immunoassay technology to identify and quantify drug presence at specified cutoff levels, supporting clinical toxicology applications. The assay is categorized under gas chromatography-based diagnostic devices and is intended for laboratory use in drug screening.
This assay is supplied as a single-use reagent kit, requiring no additional sterilization or preparation beyond standard laboratory protocols. It is intended for use in clinical toxicology settings, adhering to regulatory standards for drug testing. The device is authorized under FDA 510K clearance and is classified as a Class II medical device under the regulation number 862.3610. Cutoff levels of 300 ng/mL, 500 ng/mL (SAMHSA initial test cutoff), and 1000 ng/mL are supported, ensuring flexibility for diverse testing requirements. Storage and handling follow standard laboratory practices for immunoassay reagents.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK993982 | Date27 Jan 2000 | 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- Withdrawn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
- LAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3610
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the Syva EMIT II Plus Amphetamine/Methamphetamine Assay used for?
The Syva EMIT II Plus Amphetamine/Methamphetamine Assay is a homogeneous enzyme immunoassay designed for the qualitative and semiquantitative detection of amphetamines and methamphetamines in human urine. It supports clinical toxicology applications by identifying and quantifying drug presence at specified cutoff levels (300 ng/mL, 500 ng/mL, and 1000 ng/mL), helping laboratories screen for drug use in clinical settings.
How is the Syva EMIT II Plus Amphetamine Assay supplied, and is it single-use?
The assay is supplied as a single-use reagent kit. This means each kit is intended for one use only, eliminating the need for additional sterilization or preparation beyond standard laboratory protocols. The single-use design ensures consistency and reduces the risk of cross-contamination.
What cutoff levels does the Syva EMIT II Plus Amphetamine Assay support?
The assay supports three cutoff levels: 300 ng/mL, 500 ng/mL (which aligns with the SAMHSA initial test cutoff), and 1000 ng/mL. These levels provide flexibility for diverse testing requirements in clinical toxicology, allowing laboratories to choose the appropriate threshold based on their specific needs.
How should the Syva EMIT II Plus Amphetamine Assay be stored?
Storage and handling of the Syva EMIT II Plus Amphetamine Assay follow standard laboratory practices for immunoassay reagents. The manufacturer does not specify unique storage conditions beyond typical laboratory protocols, so it is essential to adhere to the instructions provided in the kit documentation to maintain reagent integrity and accuracy.
Is this device intended for reuse, or is it designed for single-use only?
The Syva EMIT II Plus Amphetamine Assay is explicitly designed for single-use only. This design choice ensures reliability, reduces contamination risks, and maintains the assay’s accuracy for qualitative and semiquantitative detection of amphetamines and methamphetamines in urine samples.