HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST
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 |
Indications for 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)
Related Devices
- K231978 — BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50 · Vivachek Biotech (Hangzhou) Co., Ltd. · Aug 31, 2023
- K161214 — Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) · Guangzhou Wondfo Biotech Co., Ltd. · Jun 27, 2016
- K152643 — EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana · Nantong Egens Biotech Co., Ltd. · Nov 2, 2015
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k140546
B. Purpose for Submission:
New Device
C. Measurand:
Marijuana (THC) and Methamphetamine (MET)
D. Type of Test:
Qualitative lateral flow chromatographic competitive binding immunoassay
E. Applicant:
Healgen Scientific LLC.
F. Proprietary and Established Names:
Healgen THC One Step Marijuana Test
Healgen mAMP One Step Methamphetamine Test
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LDJ | II | 21 CFR §862.3870
Cannabinoid Test System | Toxicology (91) |
| LAF | II | 21 CFR §862.3610
Methamphetamine Test System | Toxicology (91) |
H. Intended Use:
1. Intended use(s):
See Indications for use below.
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2. Indication(s) for use:
**Healgen THC One Step Marijuana Test**
Healgen One Step Marijuana Test is an immunochromatographic assay for the qualitative determination of 11-nor-Δ9-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**
Healgen 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.
3. Special conditions for use statement(s):
For over the counter (OTC) and prescription use
4. Special instrument requirements:
Not applicable. The device is a visually read single-use device.
I. Device Description:
The Healgen THC One Step Marijuana Test and Healgen mAMP One Step Methamphetamine Test come in four formats: Strip, Cassette, Cup, and Dip Card. The Healgen tests use a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and Methamphetamine in human urine.
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J. Substantial Equivalence Information:
1. Predicate device name(s): First Check Multi Drug Cup 12
2. Predicate 510(k) number(s): K052115
3. Comparison with predicate:
| Similarities and Differences | | | |
| --- | --- | --- | --- |
| Item | Healgen THC One-Step Marijuana Test (Candidate Device) | Healgen mAMP One-Step Methamphetamine Test (Candidate Device) | First Check Multi Drug Cup 12 (Predicate Device) |
| Indications for Use | For the qualitative determination of 11-nor-Δ9-THC-9-COOH | For the qualitative determination of methamphetamine | Same except this device detects a total of 12 drugs |
| Principle | Immunochromatographic lateral flow assay | Immunochromatographic lateral flow assay | Same |
| Cutoff Concentration | 50 ng/mL | 1000 ng/ mL | Same |
| Intended Use | For over-the-counter and prescription use | For over-the-counter and prescription use | For over-the-counter use |
| Configuration | Strip, Cassette, Dip Card, Cup | Strip, Cassette, Dip Card, Cup | Cup |
| Type of Test | Qualitative to indicate positive or negative result | Qualitative to indicate positive or negative result | Same |
| Specimen Type | Human urine | Human urine | Same |
K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
The devices are rapid tests for the qualitative detection of marijuana and methamphetamine in urine samples. When the absorbent end of the device is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentrations below the
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target cut off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When the analyte concentration is above the cutoff, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. When the sample contains target drug above the cutoff concentration no colored band shows in the test region, indicating a preliminary positive result. A control line (C line) is also part of each device. The C line is coated with anti-mouse IgG polyclonal antibody and serves as an internal quality control of the system. The C line appears as a red-colored band during the test regardless of the presence of the drug.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision of the Healgen THC One step Marijuana and Healgen mAMP One Step Methamphetamine tests were tested with 3 lots for each format (Strip, Cassette, Cup, Dip Card) of the device by three operators. This consisted of analyzing samples in 2 runs per day for 25 days (N=50 per lot) and by spiking drug free urine samples to achieve 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 drug concentrations. Each drug concentration was confirmed by GC/MS. Results are summarized below for each lot and device.
Strip Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 12/38 | 12/38 | 12/38 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Methamphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 14/36 | 14/36 | 14/36 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
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Cassette Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 18/32 | 18/32 | 18/32 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Methamphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 20/30 | 20/30 | 20/30 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
Cup Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 14/36 | 14/36 | 14/36 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Methamphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 22/28 | 22/28 | 22/28 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
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Dipcard Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 20/30 | 20/30 | 20/30 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
| Methamphetamine | Negative | 50 | 50/0 | 50/0 | 50/0 |
| | -75% | 50 | 50/0 | 50/0 | 50/0 |
| | -50% | 50 | 50/0 | 50/0 | 50/0 |
| | -25% | 50 | 50/0 | 50/0 | 50/0 |
| | Cut-off | 50 | 24/26 | 24/26 | 24/26 |
| | +25% | 50 | 0/50 | 0/50 | 0/50 |
| | +50% | 50 | 0/50 | 0/50 | 0/50 |
| | +75% | 50 | 0/50 | 0/50 | 0/50 |
| | +100% | 50 | 0/50 | 0/50 | 0/50 |
b. Linearity/assay reportable range:
Not applicable.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
External control materials are not supplied with the devices; however, the package insert lists a phone number the users can call to determine the commercial controls that are compatible for use with this device.
Stability protocols and acceptance criteria of all test formats were reviewed and deemed acceptable. The stability information supports the claimed shelf life of 24 months at 4 to 30 °C. The information also supports that the devices are stable for 35 days when exposed to extreme transport temperatures of -20 °C and 40 °C.
d. Detection limit:
Not applicable. The assay is intended for qualitative use.
e. Analytical specificity:
Cross-reactivity was evaluated by spiking various concentrations of similarly structured drug compounds into drug-free urine. Results are expressed as a minimum concentration of metabolite or compound required to produce a response approximately equivalent to the cutoff concentration of the assay. The percent cross-
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reactivity of those compounds is presented below:
Marijuana (THC)
| Compound | Concentration Equivalent to the Cutoff | % Cross-Reactivity |
| --- | --- | --- |
| THC (11 -nor -Δ9 -THC THC-9-COOH Cutoff =50ng/mL | 50 ng/mL | 100% |
| Delta -9-Tetrahydrocannabinol | 50,000 ng/mL | 0.1% |
| 11-nor-delta-9-THC-carboxyglucuronide | 75 ng/mL | 67% |
| (-)-11-nor-9-carboxy-delta9-THC | 50 ng/mL | 67% |
| 11-Nor-Δ9-Tetrahydrocannabinol | 50 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | 5,000 ng/mL | 1% |
| 11-Nor-Δ8-Tetrahydrocannabinol | 50 ng/mL | 100% |
| Δ8-THC-COOH | 50,000 ng/mL | 0.1% |
Methamphetamine (MET)
| Compound | Concentration Equivalent to the Cutoff | % Cross-Reactivity |
| --- | --- | --- |
| D-Methamphetamine Cutoff = 100ng/mL | 1000 ng/mL | 100% |
| (+/-) 3,4-Methylenedioxy-n-ethylamphetamine(MDEA) | 20,000 ng/mL | 5% |
| Procaine (Novocaine) | 60,000 ng/mL | 1.7% |
| Trimethobenzamide | 20,000 ng/mL | 5% |
| Methamphetamine | 1000 ng/mL | 100% |
| Ranitidine (Zantac) | 50,000 ng/mL | 2% |
| (+/-) 3,4-Methylenedioxymethamphetamine | 2500 ng/mL | 40% |
| Chloroquine | 50,000 ng/mL | 2% |
| Ephedrine | 100,000 ng/mL | 1% |
| Fenfluramine | 50,000 ng/mL | 2% |
| p-Hydroxymethamphetamine | 10,000 ng/mL | 10% |
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# Interference studies:
Interference studies were performed using $100\mu \mathrm{g / mL}$ of commonly administered or OTC compounds (endogenous compounds, drugs, drug metabolites) that are commonly found in urine. These compounds were tested in drug-free urine controls and urine containing $\pm 25\%$ cutoff concentration for each analyte using three lots of each device for all formats. The following compounds were found not to interfere when tested at $100\mu \mathrm{g / mL}$ concentration.
THC
| 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 | β-Phenylethlamine |
| D,L-Amphetamine | O-Hydroxyhippuric acid | β-Phenylethylamine |
| 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 |
| Brompheniramine | Levorphanol | Quinidine |
| Caffeine | Loperamide | Quinine |
| Chloralhydrate | Maprotiline | Ranitidine |
| Chloramphenicol | Meprobamate | Salicylic acid |
| Chlordiazepoxide | Methadone | Secobarbital |
| Chlorothiazide | Methoxyphenamine | Serotonin (5- |
| (±) Chlorpheniramine | (+) 3,4-Methylenedioxyamphetamine | Sulfamethazine |
| Chlorpromazine | (+)3,4-Methylenedioxymethampheta | Sulindac |
| Chlorquine | Methylphenidate | Temazepam |
| Cholesterol | Methyprylon | Tetracycline |
| Clomipramine | Morphine-3-β-Dglucuronide | Tetrahydrocortisone, 3 Acetate |
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| Clonidine | Nalorphine | Tetrahydrocortisone3 (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 | |
## MET
| 4-Acetamidophenol | (-) Y Ephedrine | Penicillin-G |
| --- | --- | --- |
| Acetophenetidin | Erythromycin | Pentazocaine |
| N-Acetylprocainamide | β-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 |
| Apomorphine | Hydralazine | β-Phenylethlamine |
| Aspartame | Hydrochlorothiazide | Phenylpropanolamine |
| Atropine | Hydrocodone | Prednisolone |
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| 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 |
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Specific Gravity and pH studies:
Twelve urine samples with specific gravity ranges (1.000-1.035) were collected and spiked with each drug at 25% below and 25% above cutoff levels. Each sample was tested using three lots of each format of the test devices. The results showed that a specific gravity range of 1.000 to 1.035 does not affect the accuracy of the test
A negative urine pool was adjusted to a pH range of 4.00 to 9.00 in 1 pH unit increments and was spiked with each drug at 25% below and 25% above cutoff levels. Samples were tested using three lots of each format of the devices, and results showed that urine pH range of 4.00 to 9.00 does not affect the accuracy of the accuracy of the test.
f. Assay cut-off:
The assay cutoff characterization study was performed using the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test with 3 lots for each format (Cup, Dip Card, Cassette, and Strip format) by three operators. The study samples were made by using spiking drug-free urine samples (confirmed by GC/MS) with known amount of THC or Methamphetamine. Results are shown in the tables below:
Strip Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 30/60 | 27/63 | 18/72 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Methamphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 24/66 | 30/60 | 36/54 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
Cassette Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 36/54 | 45/45 | 30/60 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Methamphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 39/51 | 48/42 | 51/39 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
{11}
Dip Card Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 42/48 | 36/54 | 48/42 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Methamphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 36/54 | 48/42 | 39/51 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
Cup Format
| Drug Test | Cut off Level | N | Result (Negative/Positive) | | |
| --- | --- | --- | --- | --- | --- |
| | | | Lot 1 | Lot 2 | Lot 3 |
| Marijuana (THC) | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 49/51 | 48/42 | 51/39 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
| Methamphetamine | -50% | 30 | 90/0 | 90/0 | 90/0 |
| | -25% | 30 | 90/0 | 90/0 | 90/0 |
| | Cut-off | 30 | 30/60 | 42/48 | 30/60 |
| | +25% | 30 | 0/90 | 0/90 | 0/90 |
| | +50% | 30 | 0/90 | 0/90 | 0/90 |
# 2. Comparison studies:
# a. Method comparison with predicate device:
The method comparison for the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test was performed internally against the reference method, GC/MS. Operators ran 80 unaltered urine samples on each format of the devices, where each device format was tested by an independent set of three operators. The samples were masked and randomized prior to testing and device results were compared to GC/MS. The results are presented in the table below:
{12}
THC Strip Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 16 | 16 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
Discordant Result of THC Strip
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 223 | 52 | Negative |
| Operator B | 207 | 53 | Negative |
| Operator B | 223 | 52 | Negative |
| Operator C | 207 | 53 | Negative |
| Operator C | 223 | 52 | Negative |
THC Cassette Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 11 | 26 |
| | Negative | 10 | 16 | 16 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 11 | 26 |
| | Negative | 10 | 16 | 16 | 3 | 0 |
{13}
Discordant Result of THC Cassette
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 223 | 52 | Negative |
| Operator A | 247 | 53 | Negative |
| Operator B | 207 | 53 | Negative |
| Operator B | 247 | 53 | Negative |
| Operator B | 223 | 52 | Negative |
| Operator C | 207 | 53 | Negative |
| Operator C | 247 | 53 | Negative |
| Operator C | 223 | 52 | Negative |
THC Cup Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 11 | 26 |
| | Negative | 10 | 16 | 16 | 3 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
Discordant Result of THC Cup
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 223 | 52 | Negative |
| Operator A | 247 | 53 | Negative |
| Operator B | 207 | 53 | Negative |
| Operator B | 247 | 53 | Negative |
| Operator B | 223 | 52 | Negative |
| Operator C | 207 | 53 | Negative |
| Operator C | 247 | 53 | Negative |
{14}
THC Dip Card Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 13 | 26 |
| | Negative | 10 | 16 | 16 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 12 | 26 |
| | Negative | 10 | 16 | 16 | 2 | 0 |
Discordant Result of THC Dip Card
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 223 | 52 | Negative |
| Operator B | 207 | 53 | Negative |
| Operator B | 223 | 52 | Negative |
| Operator C | 207 | 53 | Negative |
| Operator C | 247 | 53 | Negative |
MET Strip Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 19 | 15 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 19 | 15 | 1 | 0 |
{15}
Discordant Result of MET Strip
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 133 | 1008 | Negative |
| Operator B | 123 | 1003 | Negative |
| Operator B | 133 | 1008 | Negative |
| Operator C | 133 | 1008 | Negative |
MET Cassette Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 19 | 15 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
Discordant Result of MET Cassette
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 123 | 1003 | Negative |
| Operator A | 133 | 1008 | Negative |
| Operator B | 123 | 1003 | Negative |
| Operator C | 123 | 1003 | Negative |
| Operator C | 133 | 1008 | Negative |
{16}
MET Dip Card Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
Discordant Result of MET Dip Card
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 123 | 1003 | Negative |
| Operator A | 133 | 1008 | Negative |
| Operator B | 123 | 1003 | Negative |
| Operator B | 133 | 1008 | Negative |
| Operator C | 123 | 1003 | Negative |
| Operator C | 133 | 1008 | Negative |
MET Cup Format
| Operator | | Negative | Low Negative by GC/MS (<-50%) | Near Cutoff Negative by GC/MS (between -50% and cutoff) | Near Cutoff Positive by GC/MS (between cutoff and +50%) | High Positive by GC/MS (> +50%) |
| --- | --- | --- | --- | --- | --- | --- |
| Operator A | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 19 | 15 | 1 | 0 |
| Operator B | Positive | 0 | 0 | 0 | 12 | 27 |
| | Negative | 10 | 19 | 15 | 1 | 0 |
| Operator C | Positive | 0 | 0 | 0 | 11 | 27 |
| | Negative | 10 | 19 | 15 | 2 | 0 |
{17}
18
Discordant Result of MET Cup
| Operator | Sample Number | GC/MS result (ng/mL) | Operator result |
| --- | --- | --- | --- |
| Operator A | 123 | 1003 | Negative |
| Operator B | 123 | 1003 | Negative |
| Operator C | 123 | 1003 | Negative |
| Operator C | 133 | 1008 | Negative |
b. Matrix comparison:
Not applicable.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
A lay user study was performed at three sites with a total of 560 lay persons where 140 persons tested one of the four formats (Strip, Cassette, Dip Card, Cup) of the Healgen THC One Step Marijuana Test and the Healgen mAMP One Step Methamphetamine Test. The participants had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, ±75%, ±50%, ±25% of the cutoff by spiking drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers, blind-labeled, and randomized prior to testing. Each participant was provided with the package insert, one masked sample and a device. The results are summarized below.
{18}
Strip Format
| Drug | Cutoff | Conc. by GC/MS (ng/mL) | No.of samples | Lay Person Results | | % Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Marijuana | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 12.5 | 20 | 0 | 20 | 100% |
| | -50% | 25 | 20 | 0 | 20 | 100% |
| | -25% | 37.5 | 20 | 1 | 19 | 95% |
| | +25% | 62.5 | 20 | 19 | 1 | 95% |
| | +50% | 75 | 20 | 20 | 0 | 100% |
| | +75% | 87.5 | 20 | 20 | 0 | 100% |
| Methamphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 2 | 18 | 90% |
| | +25% | 1250 | 20 | 19 | 1 | 95% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |
Cassette Format
| Drug | Cutoff | Conc. by GC/MS (ng/mL) | No.of samples | Lay Person Results | | % Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Marijuana | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 12.5 | 20 | 0 | 20 | 100% |
| | -50% | 25 | 20 | 0 | 20 | 100% |
| | -25% | 37.5 | 20 | 1 | 19 | 95% |
| | +25% | 62.5 | 20 | 18 | 2 | 90% |
| | +50% | 75 | 20 | 20 | 0 | 100% |
| | +75% | 87.5 | 20 | 20 | 0 | 100% |
| Methamphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 1 | 19 | 95% |
| | +25% | 1250 | 20 | 19 | 1 | 95% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |
{19}
Cup Format
| Drug | Cutoff | Conc. by GC/MS (ng/mL) | No.of samples | Lay Person Results | | % Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Marijuana | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 12.5 | 20 | 0 | 20 | 100% |
| | -50% | 25 | 20 | 0 | 20 | 100% |
| | -25% | 37.5 | 20 | 3 | 17 | 85% |
| | +25% | 62.5 | 20 | 20 | 0 | 100% |
| | +50% | 75 | 20 | 20 | 0 | 100% |
| | +75% | 87.5 | 20 | 20 | 0 | 100% |
| Methamphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 1 | 19 | 95% |
| | +25% | 1250 | 20 | 17 | 3 | 85% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |
Dip Card Format
| Drug | Cutoff | Conc. by GC/MS (ng/mL) | No.of samples | Lay Person Results | | % Agreement With GC/MS |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | Negative | Positive | |
| Marijuana | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 12.5 | 20 | 0 | 20 | 100% |
| | -50% | 25 | 20 | 0 | 20 | 100% |
| | -25% | 37.5 | 20 | 2 | 18 | 90% |
| | +25% | 62.5 | 20 | 19 | 1 | 95% |
| | +50% | 75 | 20 | 20 | 0 | 100% |
| | +75% | 87.5 | 20 | 20 | 0 | 100% |
| Methamphetamine | -100% | 0 | 20 | 0 | 20 | 100% |
| | -75% | 250 | 20 | 0 | 20 | 100% |
| | -50% | 500 | 20 | 0 | 20 | 100% |
| | -25% | 750 | 20 | 1 | 19 | 95% |
| | +25% | 1250 | 20 | 20 | 0 | 100% |
| | +50% | 1500 | 20 | 20 | 0 | 100% |
| | +75% | 1750 | 20 | 20 | 0 | 100% |
{20}
The labeling is rated at 7th grade reading level per Flesch-Kincaid Methodology. All participants (100%) indicated on the questionnaire that the labeling instructions were clear and that they did not find the tests difficult to operate.
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Not applicable
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
21
