Not Cleared Direct

DEN190028 - MyCare Psychiatry Clozapine Assay Kit (FDA 510(k) Clearance)

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

DEN190028 · Saladax Biomedical, Inc. · Toxicology device
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Apr 2020
Decision
328d
Days
Class 2
Risk

DEN190028 is an FDA 510(k) submission (not cleared) for the MyCare Psychiatry Clozapine Assay Kit. Classified as Clozapine Test System (product code QKT), Class II - Special Controls.

Submitted by Saladax Biomedical, Inc. (Bethlehem, US). The FDA issued a Not Cleared (DENG) decision on April 16, 2020 after a review of 328 days.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3245 - 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 328 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 Saladax Biomedical, Inc. devices

Submission Details

510(k) Number DEN190028 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 24, 2019
Decision Date April 16, 2020
Days to Decision 328 days
Submission Type Direct
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 87d · This submission: 328d
Pathway characteristics

Device Classification

Product Code QKT Clozapine Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3245
Definition A Clozapine Test System Is Intended For The In Vitro Quantitative Measurement Of Clozapine In Human Specimens.
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.