Cleared Special

DRI Ecstasy Plus Assay

K240670 · Microgenics Corporation · Toxicology
Oct 2024
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K240670 is an FDA 510(k) clearance for the DRI Ecstasy Plus Assay, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on October 30, 2024, 233 days after receiving the submission on March 11, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K240670 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 2024
Decision Date October 30, 2024
Days to Decision 233 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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