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)
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.

View all Healgen Scientific, LLC devices

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
32d faster than avg
Panel avg: 88d · 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 84
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K151642.
Healgen Multi-Drug Urine Test Cup
K163704 · Healgen Scientific, LLC · Aug 2017
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K153597 · Healgen Scientific, LLC · May 2016
Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators
K151771 · Immunalysis Corporation · Jan 2016
Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
K150356 · Healgen Scientific, LLC · May 2015
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS
K123080 · Chemtron Biotech, Inc. · Nov 2012
CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN CASSETTE/DIPCARD
K111322 · Chemtron Biotech, Inc. · Sep 2011