HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST

K140546 · Healgen Scientific,, LLC · LDJ · Jun 6, 2014 · Clinical Toxicology

Device Facts

• Record ID: K140546
• Device Name: HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
• Applicant: Healgen Scientific,, LLC
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use. Healgen mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Story

Lateral flow immunochromatographic assays for qualitative detection of 11-nor-Δ9-THC-9-COOH or methamphetamine in human urine; utilizes monoclonal antibody-dye conjugate with gold chloride and immobilized drug-protein conjugates on membrane. Urine sample migrates via capillary action; competitive binding principle; target drug presence prevents formation of visible colored test line. Available in strip, cassette, dip card, and cup formats. Used in point-of-care or home settings by lay users or clinicians. Provides preliminary results; positive results require confirmation via GC/MS. Clinical judgment required for interpretation. Benefits include rapid, accessible screening for drug presence.

Clinical Evidence

Bench testing only. Precision, cut-off verification, interference, and specificity studies performed. Method comparison study conducted with 80 clinical samples per format compared to GC/MS. Lay-user study performed with 140 participants across three sites; results showed high concordance with GC/MS (90-100% correct results near cut-off).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Components: monoclonal antibody-dye conjugate, gold chloride, drug-protein conjugates, anti-mouse IgG polyclonal antibody. Formats: strip, cassette, dip card, cup. No energy source required. Stable at 4-30°C for 24 months.

Indications for Use

Indicated for qualitative detection of 11-nor-Δ9-THC-9-COOH (50 ng/mL) and methamphetamine (1000 ng/mL) in human urine. Intended for OTC and prescription use by individuals for preliminary drug screening.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• First Check Multi Drug Cup 12 (K052115)

Submission Summary (Full Text)

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.k140546

JUN 0 6 2014

#### 510(k) SUMMARY

- 1. Date:
May 29, 2014

Submitter: 2.

HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401

- 3. Contact person: Jianqiu Fang HEALGEN SCIENTIFIC LLC 5213 Maple St Bellaire, TX77401 Telephone: [phone] Fax: [phone] Email: [e-mail]
- 4. Device Name:

Healgen mAMP One Step Methamphetamine Test

Healgen THC One Step Marijuana Test

Classification:

| Product Code | CFR # | Panel |
|--------------|----------------------------------------------|------------|
| LDJ | 21 CFR, 862.3870 Cannabinoid Test System | Toxicology |
| LAF | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |

- 5. Predicate Devices:
K052115

FIRST CHECK DIAGNOSTICS LLC

#### 6. Intended Use

Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred

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confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

- 7. Device Description
Immunochromatographic assays for Marijuana and Methamphetamine Urine Tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

## 8. Substantial Equivalence Information

A summary comparison of features of the Healgen THC One Step Marijuana Test and Healgen mAMP One Step Methamphetamine Test and the predicate devices is provided in Table 1 & Table 2.

| Item | Device | Predicate -<br>K052115 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| Indication(s) for<br>Use | For the qualitative determination of<br>11-nor-Δ9-THC-9-COOH in human urine. | Same (but the<br>number of drugs<br>detected is different) |
| Calibrator | 11-nor-Δ9-THC-9-COOH | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or negative<br>result | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 50 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | For over-the-counter<br>use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |

Table 1: Features Comparison of Healgen THC One Step Marijuana Test and the Predicate Devices

Table 2: Features Comparison of Healgen mAMP One Step Methamphetamine Test and the Predicate Devices

| ltem | Device | Predicate - K052115 |
|--------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------|
| Indication(s) for<br>Use | For the qualitative determination of<br>Methamphetamine in human urine. | Same(but the number<br>of drugs detected is<br>different) |
| Calibrator | Methamphetamine | Same |

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| Item | Device | Predicate - K052115 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative to indicate positive or negative<br>result | Same |
| Specimen Type | Human Urine | Same |
| Cut-Off Values | 1000 ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | For over-the-counter<br>use. |
| Configurations | Strip, Cassette, Cup, Dip Card | Cup |

- 9. Test Principle
It is a rapid test for the qualitative detection of 11-nor-A9-THC-9-COOH and Methamphetamine in urine samples. It is a lateral flow chromatographic immunoassay. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen below its cut-off concentration, it will not saturate the binding sites of its specific antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles.

#### 10. Performance Characteristics

- 1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blinded labeled by the person who prepared the samples and won't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.

| Drug | Result | -100%cut<br>off | -75%cut<br>off | -50%cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut+100%cut<br>t off | |
|---------------------|----------------|------------------|----------------|-----------------|----------------|---------|----------------|----------------|--------------------------|-------------------|
| Lot:THC1110001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot:THC1110002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| Lot:THC1110003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | |
| | Result | -100% cut<br>off | -75%cut<br>off | -50%cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:THC1110004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:THC1110005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:THC1110006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| THC Cup Format | Result | -100%cut<br>off | -75%cut<br>off | -50%cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:THC1110007 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 14-/36+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:THC1110008 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 14-/36+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:THC1110009 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 14-/36+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| THC Dipcard Format | Result | -100% cut<br>off | -75%cut<br>off | -50%cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:THC1110010 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:THC1110011 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:THC1110012 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| MET Strip Format | Result | -100% cut<br>off | -75%cut<br>off | -50%cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:MET1110001 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 14-/36+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110002 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 14-/36+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110003 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 14-/36+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| MET Cassette Format | Result | -100% cut<br>off | -75%cut<br>off | -50% cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:MET1110004 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110005 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110006 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| MET Dip Card Format | Result | -100% cut<br>off | -75%cut<br>off | -50%cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:MET1110007 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110008 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110009 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| MET CUP Format | Result | -100% cut<br>off | -75%cut<br>off | -50% cut<br>off | -25%<br>cutoff | cut off | +25%cut<br>off | +50%cut<br>off | +75%cut<br>off | +100%cut<br>t off |
| Drug | Lot:MET1110010 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| | Lot:MET1110011 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### THC Strip Format

THC Cassette Format

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:

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b.Linearity

Not applicable, this is a visually read device

- c. Stability
It is stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 ℃ and real time stability determination at both 4 ℃ and 30 ℃.

## d.Cut-off

Total 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for both Marijuana and Methamphetamine. The following cut-off values for the test devices have been verified.

| Test | Calibrator | Cut-off (ng/mL) |
|-------------------------------|----------------------|-----------------|
| One Step Marijuana Test | 11-nor-Δ9-THC-9-COOH | 50 |
| One Step Methamphetamine Test | Methamphetamine | 1000 |

e. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentration at 25% below and 25% above Cut-Off level respectively. These urine samples were tested using three batches of each device for all formats.

Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed for different formats.

| 4-Acetamidophenol | Estrone-3-sulfate | Penicillin-G |
|----------------------|------------------------|---------------------|
| Acetophenetidin | Ethyl-p-aminobenzoate | Pentazocine |
| N-Acetylprocainamide | Fenoprofen | Pentobarbital |
| Acetylsalicylic acid | Furosemide | Perphenazine |
| Aminopyrine | Gentisic acid | Phencyclidine |
| Amitryptyline | Hemoglobin | Phenelzine |
| Amobarbital | Hydralazine | Phenobarbital |
| Amoxicillin | Hydrochlorothiazide | Phentermine |
| Ampicillin | Hydrocodone | L-Phenylephrine |
| Ascorbic acid | Hydrocortisone | ß-Phenylethlamine |
| D,L-Amphetamine | O-Hydroxyhippuric acid | ß-Phenyllethylamine |
| L-Amphetamine | 3-Hydroxytyramine | Phenylpropanolamine |
| Apomorphine | Ibuprofen | Prednisolone |
| Aspartame | Imipramine | Prednisone |
| Atropine | Iproniazid | Procaine |
| Benzilic acid | (-) Isoproterenol | Promazine |
| Benzoic acid | Isoxsuprine | Promethazine |
| Benzoylecgonine | Ketamine | D,L-Propanolol |
| Benzphetamine | Ketoprofen | D-Propoxyphene |
| Bilirubin | Labetalol | D-Pseudoephedrine |

#### THC:

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| Brompheniramine | Levorphanol | Quinidine |
|------------------------|--------------------------------------|------------------------------------------|
| Caffeine | Loperamide | Quinine |
| Chloralhydrate. | Maprotiline | Ranitidine |
| Chloramphenicol | Meprobamate | Salicylic acid |
| Chlordiazepoxide | Methadone | Secobarbital |
| Chlorothiazide | Methoxyphenamine | Serotonin (5-Hydroxytyramine) |
| (±) Chlorpheniramine | (+) 3,4-Methylenedioxyamphetamine | Sulfamethazine |
| Chlorpromazine | (+)3,4-Methylenedioxymethamphetamine | Sulindac |
| Chlorquine | Methylphenidate | Temazepam |
| Cholesterol | Methyprylon | Tetracycline |
| Clomipramine | Morphine-3-β-Dglucuronide | Tetrahydrocortisone, 3 Acetate |
| Clonidine | Nalorphine | Tetrahydrocortisone3<br>(5-Dglucuronide) |
| Cocaine hydrochloride | Naloxone | Tetrahydrozoline |
| Codeine | Nalidixic acid | Thebaine |
| Cortisone | Naltrexone | Thiamine |
| (-) Cotinine | Naproxen | Thioridazine |
| Creatinine | Niacinamide | D, L-Thyroxine |
| Deoxycorticosterone | Nifedipine · | Tolbutamine |
| Dextromethorphan | Norcodein | Triamterene |
| Diazepam | Norethindrone | Trifluoperazine |
| Diclofenac | D-Norpropoxyphene | Trimethoprim |
| Diflunisal | Noscapine | Trimipramine |
| Digoxin | D, L-Octopamine | Tryptamine |
| Diphenhydramine | Oxalic acid | D, L-Tryptophan |
| Doxylamine | Oxazepam | Tyramine |
| Ecgonine hydrochloride | Oxolinic acid | PrD, L-Tyrosine |
| Ecgonine methylester | Oxycodone | Uric acid |
| (-) Y Ephedrine | Oxymetazoline | Verapamil |
| Erythromycin | p-Hydroxymethamphetamine | Zomepirac |
| β-Estradiol | Papaverine | |

# МЕТ

:

| 4-Acetamidophenol | (-) Y Ephedrine | Penicillin-G |
|----------------------|-----------------------|-----------------|
| Acetophenetidin | Erythromycin | Pentazocaine |
| N-Acetylprocainamide | ß-Estradiol | Pentobarbital |
| Acetylsalicylic acid | Estrone-3-sulfate | Perphenazine |
| Aminopyrine | Ethyl-p-aminobenzoate | Phencyclidine |
| Amitryptyline | Fenfluramine | Phenelzine |
| Amobarbital | Fenoprofen | Phendimetrazine |
| Amoxicillin | Furosemide | Phenobarbital |
| Ampicillin | Gentisic acid | Phetoin |
| Ascorbic acid | Hemoglobin | L-Phenylephrine |

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| Apomorphine | Hydralazine | β-Phenylethlamine |
|------------------------|-------------------------|---------------------|
| Aspartame | Hydrochlorothiazide | Phenylpropanolamine |
| Atropine | Hydrocodone | Prednisolone |
| Benzilic acid | Hydrocortisone | Prednisone |
| Benzoic acid | O-Hydroxyhippuric acid | Procaine |
| Benzoylecgonine | 3-Hydroxytyramine | Promazine |
| Bilirubin | Ibuprofen | Promethazine |
| Brompheniramine | Imipramine | D,L-Propanolol |
| Caffeine | (-) Isoproterenol | Propiomazine |
| Cannabidiol | Isoxsuprine | D-Propoxyphene |
| Cannabinol | Ketamine | Quinidine |
| Chloralhydrate | Ketoprofen | Quinine |
| Chloramphenicol | Labetalol | Ranitidine |
| Chlordiazepoxide | Levorphanol | Salicylic acid |
| Chlorothiazide | Loperamide | Secobarbital |
| (±) Chlorpheniramine | Maprotiline | Serotonin |
| Chlorpromazine | Meperidine | Sulfamethazine |
| Chlorquine | Meprobamate | Sulindac |
| Cholesterol | Methadone | Temazepam |
| Clomipramine | Methylphenidate | Tetracycline |
| Clonidine | Morphine-3-Dglucuronide | Tetrahydrocortisone |
| Cocaine hydrochloride | Nalidixic acid | Tetrahydrozoline |
| Codeine | Naloxone | Δ9-THC-COOH |
| Cortisone | Naltrexone | Thebaine |
| (-) Cotinine | Naproxen | Thiamine |
| Creatinine | Niacinamide | Thioridazine |
| Deoxycorticosterone | Nifedipine | D,L-Thyroxine |
| Dextromethorphan | Norcodein | Tolbutamine |
| Diazepam | Norethindrone | Triamterene |
| Diclofenac | D-Norpropoxyphene | Trifluoperazine |
| Diflunisal | Noscapine | Trimethoprim |
| Digoxin | D,L-Octopamine | Trimipramine |
| Diphenhydramine | Oxalic acid | Tryptamine |
| Doxylamine | Oxazepam | D, L-Tyrosine |
| Ecgonine hydrochloride | Oxolinic acid | Uric acid |
| Ecgonine methylester | Oxycodone | Verapamil |
| (IR,2S)-(-)-Ephedrine | Oxymetazoline | Zomepirac |
| l-Ephedrine | Papaverine | Acebutolol |

f. Specificity

To test the specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device for all formats. Compounds that produced positive results are listed below. There were no differences observed for different formats.

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| THC | Result | % Cross-Reactivity |
|-----------------------------------------|--------------------------|--------------------|
| (11-nor-Δ9-THC-9-COOH, Cutoff=50 ng/mL) | Positive at 50 ng/mL | 100% |
| Delta-9-Tetrahydrocannabinol | Positive at 50,000 ng/mL | 0.1% |
| 11-nor-delta-9-THC-carboxyglucuronide | Positive at 75 ng/mL | 67% |
| (-)-11-nor-9-carboxy-delta9-THC | Positive at 75 ng/mL | 67% |
| 11-Nor-Δ9-Tetrahydrocannabinol | Positive at 50 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 5,000 ng/mL | 1% |
| 11-Nor-Δ8-Tetrahydrocannabinol | Positive at 50 ng/mL | 100% |
| Δ8-THC-COOH | Positive at 50,000 ng/mL | 0.1% |

| MET | Result | % Cross-Reactivity |
|---------------------------------------------------|---------------------------|--------------------|
| (D-Methamphetamine, Cutoff=1000 ng/mL) | Positive at 1000 ng/mL | 100% |
| (+/-) 3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | Positive at 20,000 ng/mL | 5% |
| Procaine (Novocaine) | Positive at 60,000 ng/mL | 1.7% |
| Trimethobenzamide | Positive at 20,000 ng/mL | 5% |
| Methamphetamine | Positive at 1000 ng/mL | 100% |
| Ranitidine (Zantac) | Positive at 50,000 ng/mL | 2% |
| (+/-) 3,4-Methylenedioxymethamphetamine (MDMA) | Positive at 2500 ng/mL | 40% |
| Chloroquine | Positive at 50,000 ng/mL | 2% |
| Ephedrine | Positive at 100,000 ng/mL | 1% |
| Fenfluramine | Positive at 50,000 ng/mL | 2% |
| p-Hydroxymethamphetamine | Positive at 10,000 ng/mL | 10% |

## g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, the urine samples, with 1.000~1.035 specific gravity or urine samples with pH 4~9 were spiked with target drugs at 25% below and 25% above Cut-Off level, respectively. These samples were tested using three batches of each device for all formats. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different formats.

- 2. Comparison Studies
The method comparison for the One Step Marijuana Test, and the One Step Methamphetamine Test was performed in-house with three laboratory assistants for each format of the device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results. The results are presented in the table below:

| Strip<br>format | Negative | THC | | | |
|-----------------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| | | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |

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| Viewer | | 0 | 0 | 0 | 13 | 26 |
|----------|----------|----|----|----|----|----|
| Viewer A | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 16 | 16 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |

## Discordant Results of THC Strip

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 223 | 52 | Negative |
| Viewer B | 207 | 53 | Negative |
| Viewer B | 223 | 52 | Negative |
| Viewer C | 207 | 53 | Negative |
| Viewer C | 223 | 52 | Negative |

| Cassette<br>format | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|--------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 11 | 26 |
| | Negative | 10 | 16 | 16 | 3 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 11 | 26 |
| | Negative | 10 | 16 | 16 | 3 | 0 |

# Discordant Results of THC Casette

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 223 | 52 | Negative |
| Viewer A | 247 | 53 | Negative |
| Viewer B | 207 | 53 | Negative |
| Viewer B | 247 | 53 | Negative |
| Viewer B | 223 | 52 | Negative |
| Viewer C | 207 | 53 | Negative |
| Viewer C | 247 | 53 | Negative |
| Viewer C | 223 | 52 | Negative |

| Cup<br>format | Negative | Low<br>Negative by<br>GC/MS<br>(less than -50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between -50% and | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the cutoff | High<br>Positive by<br>GC/MS<br>(greater than +50%) |
|---------------|----------|-------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------|
| | | | | | |

·

{9}------------------------------------------------

| | | | | cutoff) | and +50%) | |
|--------|----------|----|----|---------|-----------|----|
| Viewer | Positive | 0 | 0 | 0 | 12 | 26 |
| A | Negative | 10 | 16 | 16 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 11 | 26 |
| B | Negative | 10 | 16 | 16 | 3 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 12 | 26 |
| C | Negative | 10 | 16 | 16 | 2 | 0 |

# Discordant Results of THC Cup

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 223 | 52 | Negative |
| Viewer A | 247 | 53 | Negative |
| Viewer B | 207 | 53 | Negative |
| Viewer B | 247 | 53 | Negative |
| Viewer B | 223 | 52 | Negative |
| Viewer C | 207 | 53 | Negative |
| Viewer C | 247 | 53 | Negative |

| Dip<br>Card<br>format | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) | |
|-----------------------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|----|
| Viewer<br>A | Positive | 0 | 0 | 0 | 13 | 26 |
| Viewer<br>A | Negative | 10 | 16 | 16 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 12 | 26 |
| Viewer<br>B | Negative | 10 | 16 | 16 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 12 | 26 |
| Viewer<br>C | Negative | 10 | 16 | 16 | 2 | 0 |

# Discordant Results of THC Dip Card

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 223 | 52 | Negative |
| Viewer B | 207 | 53 | Negative |
| Viewer B | 223 | 52 | Negative |
| Viewer C | 207 | 53 | Negative |
| Viewer C | 247 | 53 | Negative |

{10}------------------------------------------------

| Strip<br>format | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|-----------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer | Positive | 0 | 0 | 0 | 12 | 27 |
| A | Negative | 10 | 19 | 15 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 11 | 27 |
| B | Negative | 10 | 19 | 15 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 0 | 12 | 27 |
| C | Negative | 10 | 19 | 15 | 1 | 0 |

:

#### Discordant Results of MET Strip

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer Results |
|----------|---------------|--------------|-----------------------------|
| Viewer A | 133 | 1008 | Negative |
| Viewer B | 123 | 1003 | Negative |
| Viewer B | 133 | 1008 | Negative |
| Viewer C | 133 | 1008 | Negative |

| Cassette<br>format | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|--------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 19 | 15 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |

Discordant Results of MET Cassette

:

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer | Results |
|----------|---------------|--------------|---------------------|----------|
| Viewer A | 123 | 1003 | | Negative |
| Viewer A | 133 | 1008 | | Negative |
| Viewer B | 123 | 1003 | | Negative |
| Viewer C | 123 | 1003 | | Negative |
| Viewer C | 133 | 1008 | | Negative |

.

:

-

・

{11}------------------------------------------------

| Dip<br>Card<br>format | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between<br>the cutoff<br>and +50%) | High<br>Positive by<br>GC/MS<br>(greater<br>than +50%) |
|-----------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |

## Discordant Results of MET Dip Card

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer<br>Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 123 | 1003 | Negative |
| Viewer A | 133 | 1008 | Negative |
| Viewer B | 123 | 1003 | Negative |
| Viewer B | 133 | 1008 | Negative |
| Viewer C | 123 | 1003 | Negative |
| Viewer C | 133 | 1008 | Negative |

| Cup format | | Negative | Low Negative by GC/MS (less than -50%) | Near Cutoff Negative by GC/MS (Between -50% and cutoff) | Near Cutoff Positive by GC/MS (Between the cutoff and +50%) | High Positive by GC/MS (greater than +50%) |
|------------|----------|----------|----------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------|
| Viewer A | Positive | 0 | 0 | 0 | 12 | 27 |
| Viewer A | Negative | 10 | 19 | 15 | 1 | 0 |
| Viewer B | Positive | 0 | 0 | 0 | 12 | 27 |
| Viewer B | Negative | 10 | 19 | 15 | 1 | 0 |
| Viewer C | Positive | 0 | 0 | 0 | 11 | 27 |
| Viewer C | Negative | 10 | 19 | 15 | 2 | 0 |

Discordant Results of MET Cup

| Viewer | Sample Number | GC/MS Result | Strip Format Viewer<br>Results |
|----------|---------------|--------------|--------------------------------|
| Viewer A | 123 | 1003 | Negative |
| Viewer B | 123 | 1003 | Negative |
| Viewer C | 123 | 1003 | Negative |
| Viewer C | 133 | 1008 | Negative |

# Lay-user study

A lay user study was performed at three intended user sites with 140 lay persons. For a typical Strip device study, participants were 54 females and 86 males tested the Marijuana samples, and

{12}------------------------------------------------

54 females and 86 males tested the Methamphetamine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled samples and a device. The typical results are summarized below. There are no statistic differences of layperson results between different formats of the devices.

| % of Cutoff | Number of samples | THC Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| -100%Cutoff | 20 | 0 | No. of Positive | No. of Negative | 100% |
| -75%Cutoff | 20 | 12.5 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 25 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 37.5 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 62.5 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 75 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 87.5 | 20 | 0 | 100% |

Typical Comparison between GC/MS and Lay Person Results (THC)

#### Typical Comparison between GC/MS and Lay Person Results (MET)

| % of Cutoff | Number of samples | MET Concentration by GC/MS (ng/mL) | Lay person results | | The percentage of correct results (%) |
|-------------|-------------------|------------------------------------|--------------------|-----------------|---------------------------------------|
| | | | No. of Positive | No. of Negative | |
| -100%Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75%Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 1250 | 19 | 1 | 95% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |

- 3. Clinical Studies
Not applicable

- 11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity and method comparison of the devices, it's concluded that the Healgen THC One Step Marijuana Test, and Healgen mAMP One Step Methamphetamine Test are substantially equivalent to the predicate.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS symbol, which is a stylized representation of a human figure embracing the world. The symbol is composed of three curved lines that form the shape of a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 6, 2014

HEALGEN SCIENTIFIC, LLC C/O JOE SHIA 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877

Rc: K140546

Trade/Device Name: Healgen THC One Step Marijuana Test Healgen mAMP One Step Methamphetamine Test Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: II Product Code: LDJ, LAF Dated: April 17, 2014 Received: April 18, 2014

Dear Mr. Joe Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for the stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and conment of control the device, subject to the general controls provisions of the Act. The I ou may on on on of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

1f your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Paris 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vatual the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{14}------------------------------------------------

Page 2-Mr. Joe Shia

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{15}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510{k} Number (if known) K140546

#### Device Name

Healgen THC One Step Marijuana Test Healgen mAMP One Step Methamphetamine Test

#### Indications for Use (Describe)

Healgen THC One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of II-nor-49-THC-9-COOH in human urine at a Cut-Off concentration of 50 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Healgen mAMP One Step Methamphetamine Test is an immunochromatographic assay for the qualitative determination of methamphetamine in human urine at a Cut-Off concentration of 1000 ng/mL. The test is available in a Strip format, a Cassette format, a Dip Card format and a Cup format.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{16}------------------------------------------------

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