EMIT ST Urine Methadone Assay
by Syva Co. 510(k)
Active
510(k) K840060
Overview
The EMIT ST Urine Methadone Assay is an enzyme immunoassay designed for the qualitative and semiquantitative detection of methadone in human urine. As classified under product code DJR and regulation number 862.3620, this device leverages enzyme technology to identify methadone presence at specified cutoff levels, aiding clinical toxicology assessments. It falls under the broader category of enzyme immunoassays, providing rapid and reliable results for drug monitoring purposes.
This assay is supplied as a single-use diagnostic test, intended for use in clinical laboratory or point-of-care settings where urine samples are routinely analyzed for drug presence. The device requires no special storage conditions beyond those standard for immunoassay reagents, though proper handling ensures accuracy. Authorized under FDA 510(k) clearance (K840060) with a decision date of March 19, 1984, it adheres to regulatory standards for clinical toxicology applications. No MRI safety considerations apply, as it is not a magnetic resonance-compatible device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840060 | Date19 Mar 1984 | 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- Withdrawn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
- DJR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3620
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the EMIT ST Urine Methadone Assay used for?
The EMIT ST Urine Methadone Assay is designed for the qualitative and semiquantitative detection of methadone in human urine samples. It helps clinicians assess drug presence, particularly in clinical toxicology settings, to monitor methadone use or potential misuse. The assay provides rapid results, supporting timely decision-making in both laboratory and point-of-care environments.
How is the EMIT ST Urine Methadone Assay supplied, and is it single-use?
The EMIT ST Urine Methadone Assay is supplied as a single-use diagnostic test. This means each test kit is intended for one-time use only, ensuring accuracy and preventing cross-contamination between samples. The single-use format aligns with standard practices for immunoassay reagents to maintain reliability and sterility.
What storage conditions are required for the EMIT ST Urine Methadone Assay?
The assay does not require special storage conditions beyond those typically used for immunoassay reagents. Proper handling, such as maintaining appropriate temperature and avoiding exposure to extreme conditions, is recommended to preserve the integrity of the reagents. Following manufacturer guidelines for storage ensures the assay performs as intended for accurate methadone detection.
Is the EMIT ST Urine Methadone Assay sterile, and how is sterility maintained?
As a single-use diagnostic test, the EMIT ST Urine Methadone Assay is designed to be sterile for its intended application. Sterility is maintained through proper packaging and handling procedures, which prevent contamination during storage and use. The sealed, single-use format minimizes exposure risks, ensuring the assay remains suitable for clinical toxicology testing without compromising sterility.
What regulatory pathway does the EMIT ST Urine Methadone Assay follow?
The EMIT ST Urine Methadone Assay was cleared through the FDA’s 510(k) pathway, specifically under the Traditional clearance type. It was classified under product code DJR and regulation number 862.3620, with a decision date of March 19, 1984. This pathway ensures the device meets regulatory standards for clinical toxicology applications, including safety, performance, and effectiveness for detecting methadone in urine samples.