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

K151642 · Healgen Scientific,, LLC · JXM · Aug 13, 2015 · Clinical Toxicology

Device Facts

• Record ID: K151642
• Device Name: Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
• Applicant: Healgen Scientific,, LLC
• Product Code: JXM · Clinical Toxicology
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Indications for Use

The combination of the previously cleared drugs of abuse test devices (cleared in k142280, k143187, k141647, k140546, k150791, and k150096) into the candidate multi-test devices that can detect a combination of up to 12 drugs of abuse at the same time

Device Story

Multi-drug test device; combines multiple previously cleared lateral flow immunoassay strips into single format (strip, cassette, dip card, or cup). Input: human urine specimen. Principle: competitive binding immunoassay; drug in sample competes with drug conjugate for limited antibody binding sites. Output: visual color change on test line indicating presence or absence of specific drug analytes. Used in clinical/point-of-care settings; operated by healthcare professionals. Results interpreted visually by user; provides rapid screening for drug presence to assist clinical decision-making regarding substance use.

Clinical Evidence

Bench testing only. Verification studies conducted to support multi-drug configuration, including interference studies and a lay-user study. No clinical trial data provided.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: multi-drug test cup and dip card. Analyte detection via specific antibody-antigen interactions. Qualitative visual readout. No electronic components or software.

Indications for Use

Indicated for the qualitative detection of up to 12 drugs of abuse in human urine specimens. Intended for use by healthcare professionals and in point-of-care settings for screening purposes.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

• Healgen Oxazepam and Morphine Tests (K142280)
• Healgen Amphetamine and Oxycodone Tests (K143187)
• Healgen Cocaine and Morphine Tests (K141647)
• Healgen Marijuana and Methamphetamine Tests (K140546)
• Healgen Secobarbital, Buprenorphine and Methadone Tests (K150791)
• Healgen Methylenedioxy-methamphetamine and Phencyclidine Tests (K150096)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K151642

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

K142280, Healgen Oxazepam Test (Strip, Cassette, Dip Card, Cup), Healgen Morphine Test (Strip, Cassette, Dip Card, Cup);
K143187, Healgen Amphetamine Test (Strip, Cassette, Dip Card, Cup), Healgen Oxycodone Test (Strip, Cassette, Dip Card, Cup);
K141647, Healgen COC One Step Cocaine Test (Strip, Cassette, Dip Card, Cup);
K140546, Healgen THC One Step Marijuana Test, Healgen mAMP One Step Methamphetamine Test
K150791, Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Buprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)
K150096, Healgen MDMA (Ecstasy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

The combination of the previously cleared drugs of abuse test devices (cleared in k142280, k143187, k141647, k140546, k150791, and k150096) into the candidate multi-test devices that can detect a combination of up to 12 drugs of abuse at the same time

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and cutoffs.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.