Emit II Plus Cocaine Metabolite Assay

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031512 ↗

FDA Product Code

DIO

Device Class

Class II

Regulation

21 CFR Part 862.3250

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Emit II Plus Cocaine Metabolite Assay?

  This device is an enzyme immunoassay used for the qualitative and semi-quantitative determination of benzoylecgonine, which is a cocaine metabolite, in human urine samples.

• What are the detection cutoff levels for this assay?

  The assay is designed to detect the presence of the cocaine metabolite at specific cutoff levels of either 150 ng/mL or 300 ng/mL.

• Who is the intended user for this device?

  The Emit II Plus Cocaine Metabolite Assay is intended for professional laboratory use and is designed for clinical toxicology applications.

• Is this device authorized for clinical use?

  Yes, this device is authorized for use under FDA 510(k) clearance, which indicates it has been reviewed and cleared for its intended clinical toxicology applications.