BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20

K192515 · Shenzhen Bioeasy Biotechnology Co., Ltd. · LDJ · Oct 11, 2019 · Clinical Toxicology

Device Facts

• Record ID: K192515
• Device Name: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20
• Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Oct 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

BIOEASY Marijuana Test Dip Card 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL. 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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Strip 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL. 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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Dip Card 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL. 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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. BIOEASY Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL. 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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

Single-use, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine; prescription use. Device formats include dip cards and test strips. Principle: competitive binding; urine specimen migrates via capillary action; target drug below cutoff allows antibody-coated particles to bind immobilized drug-conjugate, forming visible line; drug above cutoff saturates binding sites, preventing line formation. Control line indicates proper test performance. Used in clinical settings; operated by healthcare professionals. Provides preliminary results; requires confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits: rapid, preliminary screening for marijuana presence.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (n=60 per concentration level per lot) and method comparison studies (n=80 clinical samples per format) against LC/MS reference method. Evaluated interference from physiological/pathological substances, cross-reactivity, and effects of urine pH/specific gravity. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: dip card and test strip. Analyte: Marijuana (11-nor-Δ9-THC-9-COOH). Cutoffs: 20 ng/mL and 40 ng/mL. Stability: 24 months at 4-30°C. No electronic components, software, or connectivity.

Indications for Use

Indicated for qualitative detection of Marijuana in human urine for prescription use. Cutoff concentrations are 20 ng/mL or 40 ng/mL. Results are preliminary; requires confirmation via GC/MS or LC/MS.

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).

Submission Summary (Full Text)

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October 11, 2019

Shenzhen Bioeasy Biotechnology Co.,Ltd. % Joe Shia, Director LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877

### Re: K192515

Trade/Device Name: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: September 3, 2019 Received: September 13, 2019

Dear 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 use 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). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions 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.

If 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, Parts 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 comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kellie Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) k192515

#### Device Name

BIOEASY Marijuana Test Dip Card 40; BIOEASY Marijuana Test Dip Card 20; BIOEASY Marijuana Test Strip 40; BIOEASY Marijuana Test Strip 20

#### Indications for Use (Describe)

BIOEASY Marijuana Test Dip Card 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL.

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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BIOEASY Marijuana Test Strip 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL.

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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BIOEASY Marijuana Test Dip Card 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.

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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

BIOEASY Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.

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 or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

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

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 201 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 201 Subpart G) |

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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### K192515 510(k) SUMMARY

| 1. Date: | October 10, 2019 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Submitter: | Shenzhen Bioeasy Biotechnology Co., Ltd.<br>No.2-1, Liuxian 1st Road<br>Baoan District<br>Shenzhen, China 518101 |
| 3. Contact person: | Joe Shia<br>LSI International Inc.<br>504E Diamond Ave., Suite I<br>Gaithersburg, MD 20877<br>Telephone: [phone]<br>Email: [e-mail] |
| 4. Device Name: | BIOEASY Marijuana Test Dip Card 20<br>BIOEASY Marijuana Test Strip 20<br>BIOEASY Marijuana Test Dip Card 40<br>BIOEASY Marijuana Test Strip 40 |

| Classification: | Class 2 | | |
|-----------------|----------------|---------------------------------|-----------------|
| Product Code | Classification | Regulation Section | Panel |
| LDJ | II | 21 CFR § 862.3870, Cannabinoids | Toxicology (91) |
| Cannabinoids | | Test System | |

- 5. Predicate Devices: K182530
The Bioeasy Multi-Drug Test Cup

- 6. Indications for Use
BIOEASY Marijuana Test Dip Card 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.

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 or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

BIOEASY Marijuana Test Dip Card 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL.

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 or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

BIOEASY Marijuana Test Strip 20 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 20 ng/mL.

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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 or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

BIOEASY Marijuana Test Strip 40 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 40 ng/mL.

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 or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

- 7. Device Description
The BIOEASY Marijuana Test Dip Card and the BIOEASY Marijuana Test Strip tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device and a package insert. Each test device is sealed with a desiccant in an aluminum pouch

- 8. Substantial Equivalence Information
A summary comparison of features of the BIOEASY Marijuana Test devices and the predicate devices is provided in following table.

| Item | Device | Predicate - K182530 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indication(s) for Use | For the qualitative determination of marijuana in human urine. | Same (but the number of drugs detected is different) |
| Calibrator and Cut-Off Values | Marijuana (THC)<br>20 ng/ml<br>or 40 ng/ml | 50 ng/ml |
| Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription use | For over-the-counter |
| Configurations | Dip Card and Strip | Cup |

### Table 1: Features Comparison of BIOEASY Marijuana Test devices and the Predicate Devices

### 9. Test Principle

The BIOEASY Marijuana Test Dip Card and the BIOEASY Marijuana Test Strip tests are rapid tests for the qualitative detection of Marijuana in urine samples. The tests are lateral flow

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chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If the target drug present in the urine specimen is below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse 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 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. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

### 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 11-Nor-△9-THC-9-COOH in negative samples. Each 11-Nor-△9-THC-9-COOH concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed six runs per day for 10 days per device lot in a randomized order. The results obtained are summarized in the following tables.

| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|------------|---------------|--------------|--------------|-------------|---------|--------------|--------------|--------------|---------------|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 32-/28+ | 59+/1- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 29-/31+ | 59+/1- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 30-/30+ | 58+/2- | 60+/0- | 60+/0- | 60+/0- |

#### Dip Card of 20ng/mL Cut-off

#### Strip of 20ng/mL Cut-off

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 30-/30+ | 58+/2- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 32-/28+ | 58+/2- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 31-/29+ | 57+/3- | 60+/0- | 60+/0- | 60+/0- |

#### Dip Card of 40ng/mL Cut-off

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 31-/29+ | 58+/2- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 57-/3+ | 28-/32+ | 59+/1- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 29-/31+ | 59+/1- | 60+/0- | 60+/0- | 60+/0- |

#### Strip of 40ng/mL Cut-off

| Lot<br>Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 32-/28+ | 59+/1- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 29-/31+ | 57+/3- | 60+/0- | 60+/0- | 60+/0- |

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| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 31-/29+ | 58+/2- | 60+/0- | 60+/0- | 60+/0- |
|-------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
|-------|--------|--------|--------|--------|---------|--------|--------|--------|--------|

#### c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 ℃ and real time stability determinations at both 4 ℃ and 30 ℃.

#### d. Interference

Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL and ethanol was tested at 1%) are summarized in the following tables. There were no differences observed for both the strip and dip card formats at the two different cut-offs.

| Acetaminophen | ß-Estradiol | Oxalic acid |
|-----------------------|------------------------|--------------------------------|
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | Ethanol (1% v/v) | Oxymetazoline |
| Acetylsalicylic acid | Fenoprofen | Papaverine |
| Albumin (100 mg/dL) | Furosemide | Penicillin G |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Apomorphine | Hydrochlorothiazide | (±)-Propranolol |
| Ascorbic acid | Hydrocortisone | Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloral hydrate | Ketamine | Sulindac |
| | | Tetrahydrocortisone 3-(β- |
| Chloramphenicol | Ketoprofen | Dglucuronide) |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
| Cholesterol | Meperidine | Thiamine |
| Clonidine | Meprobamate | Thioridazine |
| Cortisone | Methoxyphenamine | Triamterene |
| (-)-Cotinine | Nalidixic acid | Trifluoperazine |
| Creatinine | Naloxone | Trimethoprim |
| Deoxycorticosterone | Naltrexone | DL-Tryptophan |
| Dextromethorphan | Naproxen | Tyramine |
| Diclofenac | Niacinamide | DL-Tyrosine |
| Diflunisal | Nifedipine | Uric acid |
| Digoxin | Norethindrone | Verapamil |
| Diphenhydramine | Noscapine | Zomepirac |
| Ecgonine methyl ester | (±)-Octopamine | |

#### e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device format. The lowest concentration that caused a positive result for each compound are listed below. There are no differences for different device formats.

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| For cut-off 20ng/mL | | |
|-----------------------------------------------------------------|-------------------------|--------------------|
| THC(Cannabinoids)<br>(11-nor-Δ9-THC-9-COOH, Cut-off = 20 ng/mL) | Result | % Cross-Reactivity |
| 11-nor-Δ9-THC-9-COOH | Positive at 20 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 20 ng/mL | 100% |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 20 ng/mL | 100% |
| Cannabinol | Positive at 8000 ng/mL | 0.25% |
| Δ8-Tetrahydrocannabinol | Positive at 6000 ng/mL | 0.33% |
| Δ9-Tetrahydrocannabinol | Positive at 6000 ng/mL | 0.33% |
| Cannabidiol | Positive> 100000 ng/mL | <0.02% |
| 11-Nor-Δ9-THC-carboxy glucuronide | Positive at 30 ng/mL | 66.7% |
| (-)-11-nor-9-carboxy-Δ 9-THC | Positive at 20 ng/mL | 100% |
| For cut-off 40ng/mL | | |
| THC(Cannabinoids)<br>(11-nor-Δ9-THC-9-COOH, Cut-off = 40 ng/mL) | Result | % Cross-Reactivity |
| 11-nor-Δ9-THC-9-COOH | Positive at 40 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 40 ng/mL | 100% |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 40 ng/mL | 100% |
| Cannabinol | Positive at 16000 ng/mL | 0.25% |
| Δ8-Tetrahydrocannabinol | Positive at 12000 ng/mL | 0.33% |
| Δ9-Tetrahydrocannabinol | Positive at 12000 ng/mL | 0.33% |
| Cannabidiol | Positive> 100000 ng/mL | <0.04% |
| 11-Nor-Δ9-THC-carboxy glucuronide | Positive at 60 ng/mL | 66.7% |

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

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of each device format. Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off. There were no differences observed for different device formats of the two different cutoffs.

### 2. Comparison Studies

Method comparison studies for the BIOEASY Marijuana test devices were performed in-house with three laboratory assistants for each device format. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below.

| | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|----------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 2 | 18 | 20 |

### Strip Format of 20ng/mL Cut-off

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| A | Negative | 6 | 16 | 16 | 2 | 0 |
|----------|----------|---|----|----|----|----|
| Operator | Positive | 0 | 0 | 3 | 18 | 20 |
| B | Negative | 6 | 16 | 15 | 2 | 0 |
| Operator | Positive | 0 | 0 | 2 | 18 | 20 |
| C | Negative | 6 | 16 | 16 | 2 | 0 |

## Discordant Results

| Operator | Sample Number | LC/MS Result | BIOEASY<br>Results |
|------------|---------------|--------------|--------------------|
| Operator A | THCC473 | 19.1 | Positive |
| Operator A | THCC356 | 18.4 | Positive |
| Operator B | THCC312 | 17.5 | Positive |
| Operator B | THCC473 | 19.1 | Positive |
| Operator B | THCC500 | 16.2 | Positive |
| Operator C | THCC312 | 17.5 | Positive |
| Operator C | THCC356 | 18.4 | Positive |
| Operator A | THCC373 | 20.3 | Negative |
| Operator A | THCC350 | 22.6 | Negative |
| Operator B | THCC385 | 21.6 | Negative |
| Operator B | THCC342 | 22.9 | Negative |
| Operator C | THCC373 | 20.3 | Negative |
| Operator C | THCC350 | 22.6 | Negative |

# Dip Card Format of 20ng/mL Cut-off

| | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|---------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator<br>D | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 6 | 16 | 16 | 2 | 0 |
| Operator<br>E | Positive | 0 | 0 | 2 | 19 | 20 |
| | Negative | 6 | 16 | 16 | 1 | 0 |
| Operator<br>F | Positive | 0 | 0 | 3 | 18 | 20 |
| | Negative | 6 | 16 | 15 | 2 | 0 |

# Discordant Results

| Operator | Sample Number | LC/MS Result | BIOEASY Results |
|------------|---------------|--------------|-----------------|
| Operator D | THCC312 | 17.5 | Positive |
| Operator D | THCC473 | 19.1 | Positive |
| Operator E | THCC473 | 19.1 | Positive |
| Operator E | THCC356 | 18.4 | Positive |
| Operator F | THCC312 | 17.5 | Positive |
| Operator F | THCC473 | 19.1 | Positive |
| Operator F | THCC356 | 18.4 | Positive |
| Operator D | THCC373 | 20.3 | Negative |
| Operator D | THCC350 | 22.6 | Negative |

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

| Operator E | THCC385 | 21.6 | Negative |
|------------|---------|------|----------|
| Operator F | THCC373 | 20.3 | Negative |
| Operator F | THCC350 | 22.6 | Negative |

# Strip Format of 40ng/mL Cut-off

| | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|----------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 1 | 17 | 22 |
| A | Negative | 6 | 13 | 20 | 1 | 0 |
| Operator | Positive | 0 | 0 | 1 | 16 | 22 |
| B | Negative | 6 | 13 | 20 | 2 | 0 |
| Operator | Positive | 0 | 0 | 1 | 17 | 22 |
| C | Negative | 6 | 13 | 20 | 1 | 0 |

### Discordant Results

| Operator | Sample Number | LC/MS Result | BIOEASY<br>Results |
|------------|---------------|--------------|--------------------|
| Operator A | THCC365 | 39.35 | Positive |
| Operator B | THCC412 | 38 | Positive |
| Operator C | THCC412 | 38 | Positive |
| Operator A | THCC371 | 40.95 | Negative |
| Operator B | THCC371 | 40.95 | Negative |
| Operator B | THCC374 | 41.45 | Negative |
| Operator C | THCC379 | 43.15 | Negative |

# Dip Card Format of 40ng/mL Cut-off

| | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|----------|----------|----------|-------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------|
| Operator | Positive | 0 | 0 | 2 | 17 | 22 |
| D | Negative | 6 | 13 | 19 | 1 | 0 |
| Operator | Positive | 0 | 0 | 1 | 16 | 22 |
| E | Negative | 6 | 13 | 20 | 2 | 0 |
| Operator | Positive | 0 | 0 | 2 | 16 | 22 |
| F | Negative | 6 | 13 | 19 | 2 | 0 |

### Discordant Results

| Operator | Sample Number | LC/MS Result | BIOEASY Results |
|------------|---------------|--------------|-----------------|
| Operator D | THCC365 | 39.35 | Positive |
| Operator D | THCC433 | 37.1 | Positive |
| Operator E | THCC412 | 38 | Positive |

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

| Operator F | THCC412 | 38 | Positive |
|------------|---------|-------|----------|
| Operator F | THCC365 | 39.35 | Positive |
| Operator D | THCC371 | 40.95 | Negative |
| Operator E | THCC371 | 40.95 | Negative |
| Operator E | THCC374 | 41.45 | Negative |
| Operator F | THCC379 | 43.15 | Negative |
| Operator F | THCC374 | 41.45 | Negative |

### 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 studies of the devices, it's concluded that the BIOEASY Marijuana Test Dip Card and BIOEASY Marijuana Test Strip tests are substantially equivalent to the predicate.