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

K153597 · Healgen Scientific,, LLC · JXM · May 23, 2016 · Clinical Toxicology

Device Facts

• Record ID: K153597
• Device Name: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card
• Applicant: Healgen Scientific,, LLC
• Product Code: JXM · Clinical Toxicology
• Decision Date: May 23, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Indications for Use

The Healgen drug test devices are lateral flow chromatographic immunoassays for the qualitative detection of specific drugs and their metabolites in human urine at the following cutoff concentrations: Amphetamine (AMP) 1000 ng/mL, Oxycodone (OXY) 100 ng/mL, Cocaine (COC) 300 ng/mL, Marijuana (THC) 50 ng/mL, Methamphetamine (MET) 1000 ng/mL, Secobarbital (BAR) 300 ng/mL, Buprenorphine (BUP) 10 ng/mL, Methadone (MTD) 300 ng/mL, MDMA 500 ng/mL, Phencyclidine (PCP) 25 ng/mL, Nortriptyline (TCA) 1000 ng/mL, EDDP 300 ng/mL, Oxazepam (BZO) 300 ng/mL, and Morphine (OPI) 2000 ng/mL. The devices are intended for healthcare professional use, including professional use at point-of-care sites, to assist in the determination of drug compliance. The devices provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or liquid chromatography/tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Device Story

Lateral flow immunochromatographic assay; competitive binding principle. Input: human urine sample. Device consists of test strips in cup or dip card format. Output: visual colored lines in test regions (negative result) or absence of lines (positive result); control line confirms test validity. Used in point-of-care or home settings by lay users or professionals. Provides preliminary results; requires GC/MS confirmation. Assists in identifying presence of specific drugs of abuse; aids clinical decision-making regarding substance use.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence demonstrated through design control activities, risk analysis, and verification of performance characteristics (cutoffs, sensitivity, specificity) compared to previously cleared individual assays.

Technological Characteristics

Lateral flow chromatographic immunoassay; competitive binding format. Integrated cup and dipcard form factors. Materials: nitrocellulose membrane, colloidal gold-labeled antibodies, drug-protein conjugates. No electronic components, software, or external energy sources. Manual operation; visual interpretation of results.

Indications for Use

Indicated for qualitative, simultaneous detection of 14 specific drugs of abuse (Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, EDDP, Nortriptyline, Methadone) in human urine. Intended for both prescription and over-the-counter (OTC) use. Not intended to distinguish between prescription use and abuse.

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)
• Healgen Nortriptyline and EDDP Tests (K151348)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER k153597

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:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
K142280 Healgen Oxazepam and Morphine Tests
K143187 Healgen Amphetamine and Oxycodone Tests
K141647 Healgen Cocaine Test
K140546 Healgen Marijuana and Methamphetamine Tests
K150791 Healgen Secobarbital, Buprenorphine, and Methadone Tests
K150096 Healgen MDMA and Phencyclidine Tests
K151348 Healgen Nortriptyline and EDDP Tests

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.

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 fourteen previously cleared assays (test strips) into a single device in cup and dipcard formats.

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.