EMIT-ST Cannabinoid Assay
by Syva Co. 510(k)
Active
510(k) K812195
Overview
The EMIT-ST Cannabinoid Assay is an enzyme immunoassay designed for the qualitative and semiquantitative detection of cannabinoids in human urine. Classified as a Class II device under FDA regulations (21 CFR 862.3870), it operates on the principle of enzyme-multiplied immunoassay technique (EMIT) to identify cannabinoid metabolites at specified cutoff levels, including 20 ng/mL, 50 ng/mL, and 100 ng/mL. This assay is intended for clinical toxicology applications, aiding in the identification of cannabinoid exposure in forensic or medical settings.
The device is supplied as a single-use reagent kit (product code LDJ) and requires laboratory processing. It is not intended for MRI use and must be handled according to standard laboratory protocols for immunoassays. The assay is regulated under FDA 510(k) clearance (K812195) and is classified for use in clinical toxicology, with no indication of sterility or reusable components. Storage and handling follow typical immunoassay guidelines, ensuring stability and accuracy of results.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK812195 | Date20 Aug 1981 | 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- Withdrawn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
- LDJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.3870
- Advisory Committee
- Clinical Toxicology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What types of cannabinoid cutoff levels does the EMIT-ST Cannabinoid Assay detect in urine samples?
The EMIT-ST Cannabinoid Assay is designed to qualitatively and semiquantitatively detect cannabinoid metabolites in human urine at three specified cutoff levels: 20 ng/mL, 50 ng/mL, and 100 ng/mL. These thresholds help identify varying levels of cannabinoid exposure for clinical toxicology applications.
Is the EMIT-ST Cannabinoid Assay intended for single-use or reusable applications, and how is it supplied?
The EMIT-ST Cannabinoid Assay is supplied as a single-use reagent kit (product code LDJ) and is not intended for reuse. Each kit is meant for laboratory processing of one assay, adhering to standard immunoassay protocols.
What kind of regulatory clearance does the EMIT-ST Cannabinoid Assay hold, and what is its intended use?
The EMIT-ST Cannabinoid Assay holds FDA 510(k) clearance (K812195) and is classified as a Class II device under FDA regulations (21 CFR 862.3870). It is intended exclusively for clinical toxicology applications, such as identifying cannabinoid exposure in forensic or medical settings.
Does the EMIT-ST Cannabinoid Assay require any special handling or storage conditions beyond typical immunoassay guidelines?
The EMIT-ST Cannabinoid Assay must be handled according to standard laboratory protocols for immunoassays, which include maintaining stability and accuracy of results. While specific storage conditions aren’t detailed beyond typical immunoassay guidelines, it is critical to follow manufacturer instructions to ensure reliable performance.
Can the EMIT-ST Cannabinoid Assay be used in non-laboratory settings, such as point-of-care testing?
No, the EMIT-ST Cannabinoid Assay is explicitly designed for laboratory processing and is not intended for point-of-care or non-laboratory use. Its use is restricted to controlled laboratory environments where proper handling and interpretation of results can be ensured.