Not Cleared Direct

DEN170010 - LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN170010 · Lin-Zhi International, Inc. · Toxicology device
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Apr 2018
Decision
423d
Days
Class 2
Risk

DEN170010 is an FDA 510(k) submission (not cleared) for the LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay. Classified as Meprobamate Test System (product code QBK), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Not Cleared (DENG) decision on April 20, 2018 after a review of 423 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3590 - the FDA toxicology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 423 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number DEN170010 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 21, 2017
Decision Date April 20, 2018
Days to Decision 423 days
Submission Type Direct
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
336d slower than avg
Panel avg: 87d · This submission: 423d
Pathway characteristics

Device Classification

Product Code QBK Meprobamate Test System
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.