Cleared Special

K151642 - Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card

K151642 is an FDA 510(k) clearance for Heagen Multi-Drug Urine Test Cup, manufactured by Healgen Scientific, LLC. The device is a Class 2 Chemistry device with product code JXM cleared through the Special 510(k) pathway after a 56-day FDA review.

K151642 · Healgen Scientific, LLC · Chemistry device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Aug 2015

Decision

56d

Days

Class 2

Risk

K151642 is an FDA 510(k) clearance for the Heagen 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 August 13, 2015 after a review of 56 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K151642

510(k) Number	K151642 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 18, 2015
Decision Date	August 13, 2015
Days to Decision	56 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

33d faster than avg

Panel avg: 89d · This submission: 56d

Pathway characteristics

Modification to existing cleared device.

JXM Device Classification - Class 2, Special Controls

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 Consultant

LSI International, Inc.

JOE SHIA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JXM Enzyme Immunoassay, Benzodiazepine

All 89

Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K151642.

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FDA 510(k) Resources - Chemistry

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.