Cleared Traditional

CEDIA Heroin Metabolite (6-AM) Assay

K231007 · Microgenics Corporation · Chemistry
Sep 2023
Decision
173d
Days
Class 2
Risk

About This 510(k) Submission

K231007 is an FDA 510(k) clearance for the CEDIA Heroin Metabolite (6-AM) Assay, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on September 27, 2023, 173 days after receiving the submission on April 7, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K231007 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2023
Decision Date September 27, 2023
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

Similar Devices — DJG Enzyme Immunoassay, Opiates

All 214
Labcorp Fentanyl Urine Visual Test
K252684 · Medtox Diagnostics, Inc. · Jan 2026
Evidence MultiSTAT DOA Urine MultiPlex
K250741 · Randox Laboratories Limited · Jan 2026
LZI Buprenorphine II Enzyme Immunoassay
K253082 · Lin-Zhi International, Inc. · Jan 2026
SEFRIA? Hydrocodone Oral Fluid
K252520 · Immunalysis Corporation · Sep 2025
Healgen? AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative; Healgen? Immunofluorescence Analyzer (OG-H180)
K251972 · Healgen Scientific, LLC · Aug 2025
LZI Fentanyl III Enzyme Immunoassay
K251634 · Lin-Zhi International, Inc. · Jun 2025