Cleared Traditional

Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA

K190397 · Immunalysis Corporation · Toxicology
Nov 2019
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K190397 is an FDA 510(k) clearance for the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA, a Meprobamate Test System (Class II — Special Controls, product code QBK), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on November 15, 2019, 269 days after receiving the submission on February 19, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3590.

Submission Details

510(k) Number K190397 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2019
Decision Date November 15, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code QBK — Meprobamate Test System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3590
Definition A Meprobamate Test System Is A Device Intended To Measure Meprobamate In Human Specimens. Measurements Obtained By This Device Are Used To Detect The Presence Of Meprobamate To Diagnose The Use Or Overdose Of Meprobamate Or Structurally-related Drug Compounds (e.g., Prodrugs).