Cleared Special

K150356 - Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (FDA 510(k) Clearance)

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

K150356 · Healgen Scientific, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
90d
Days
Class 2
Risk

K150356 is an FDA 510(k) clearance for the Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on May 13, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3170 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Healgen Scientific, LLC devices

Submission Details

510(k) Number K150356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2015
Decision Date May 13, 2015
Days to Decision 90 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 Chemistry devices follow this clearance model.

Regulatory Peers - JXM Enzyme Immunoassay, Benzodiazepine

All 89
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