BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip

K192301 · Shenzhen Bioeasy Biotechnology Co., Ltd. · NFW · Sep 20, 2019 · Clinical Toxicology

Device Facts

• Record ID: K192301
• Device Name: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip
• Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
• Product Code: NFW · Clinical Toxicology
• Decision Date: Sep 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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

Lateral flow immunochromatographic assay for qualitative detection of Marijuana (11-Nor-Δ9-THC-9-COOH) in human urine; 50 ng/mL cutoff. Urine sample migrates via capillary action; competitive binding mechanism uses monoclonal mouse antibodies coated on particles. If drug concentration is below cutoff, antibody-coated particles bind to immobilized drug-conjugate, forming visible colored test line. If drug concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line confirms proper test performance. Used in home or point-of-care settings by lay users; results interpreted visually by user. Provides preliminary screening; requires confirmatory testing by GC/MS or LC/MS for clinical decision-making. Benefits include rapid, accessible preliminary detection of marijuana use.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies, interference testing, specificity/cross-reactivity, and method comparison against LC/MS. Lay-user study (n=280) across diverse demographics confirmed ease of use and accuracy; results showed high concordance with LC/MS across concentrations relative to the 50 ng/mL cutoff. No clinical studies performed.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use test device in aluminum pouch with desiccant. Analyte: 11-Nor-Δ9-THC-9-COOH. Cutoff: 50 ng/mL. Visual readout. No electronic components or software.

Indications for Use

Indicated for qualitative detection of Marijuana in human urine at 50 ng/mL cutoff. Intended for over-the-counter use. Provides preliminary results; requires confirmatory testing 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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2019

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

Re: K192301

Trade/Device Name: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: NFW Dated: August 18, 2019 Received: August 23, 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 B. 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 Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) k192301

Device Name BIOEASY Marijuana Test Dip Card BIOEASY Marijuana Test Strip

#### Indications for Use (Describe)

BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K192301 510(k) SUMMARY

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

Classification: Class 2

| Product Code | Classification | Regulation Section | Panel |
|---------------------|----------------|------------------------------------------------|-----------------|
| NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids<br>Test System | Toxicology (91) |

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

- 6. Indications for Use
BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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 is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 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

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aluminum pouch

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

| Item | Device | Predicate - K182530 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>marijuana in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and Cut-Off<br>Values | 11-Nor-Δ9-THC-9-COOH<br>50 ng/ml | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Dip Card and Strip | Cup |

### Table 1: Features Comparison of BIOEASY Marijuana Test Dip Card and BIOEASY Mariiuana Test Strip tests 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 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 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. 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

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samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.

| 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 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

#### Dip Card

Strip

| 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 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/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 25% below and 25% 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.

| 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 |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |

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| 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.

| THC(Cannabinoids)<br>(11-nor-Δ9-THC-9-COOH, Cut-off = 50 ng/mL) | Result | % Cross-Reactivity |
|-----------------------------------------------------------------|-------------------------|--------------------|
| 11-nor-Δ9-THC-9-COOH | Positive at 50 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 50 ng/mL | 100% |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 50 ng/mL | 100% |
| Cannabinol | Positive at 20000 ng/mL | 0.25% |
| Δ8-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33% |
| Δ9-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33% |
| Cannabidiol | Positive > 100000 ng/mL | <0.05% |
| 11-Nor-Δ9-THC-carboxy glucuronide | Positive at 75 ng/mL | 66.7% |
| (-)-11-nor-9-carboxy-Δ 9-THC | Positive at 50 ng/mL | 100% |

# 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 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device format. 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 device formats.

- 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.

## Strip Format

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| | | 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%) |
|-------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 21 | 18 |
| | Negative | 6 | 14 | 19 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 20 | 18 |
| | Negative | 6 | 14 | 19 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 2 | 21 | 18 |
| | Negative | 6 | 14 | 18 | 1 | 0 |

# Discordant Results

| Viewer | Sample Number | LC/MS Result | BIOEASY<br>Results |
|----------|---------------|--------------|--------------------|
| Viewer A | THCC368 | 48.8 | Positive |
| Viewer B | THCC363 | 46.95 | Positive |
| Viewer C | THCC368 | 48.8 | Positive |
| Viewer C | THCC363 | 46.95 | Positive |
| Viewer A | THCC493 | 50.5 | Negative |
| Viewer B | THCC493 | 50.5 | Negative |
| Viewer B | THCC478 | 55.5 | Negative |
| Viewer C | THCC493 | 50.5 | Negative |

# Dip Card Format

| | | 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%) |
|--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer | Positive | 0 | 0 | 2 | 20 | 18 |
| D | Negative | 6 | 14 | 18 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 18 |
| E | Negative | 6 | 14 | 19 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 2 | 20 | 18 |
| F | Negative | 6 | 14 | 18 | 2 | 0 |

# Discordant Results

| Viewer | Sample Number | LC/MS Result | BIOEASY<br>Results |
|----------|---------------|--------------|--------------------|
| Viewer D | THCC368 | 48.8 | Positive |
| Viewer D | THCC402 | 46 | Positive |
| Viewer E | THCC363 | 46.95 | Positive |
| Viewer F | THCC363 | 46.95 | Positive |
| Viewer F | THCC368 | 48.8 | Positive |
| Viewer D | THCC478 | 55.5 | Negative |
| Viewer D | THCC493 | 50.5 | Negative |

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| Viewer E | THCC478 | 55.5 | Negative |
|----------|---------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Viewer E | THCC493 | 50.5 | Negative |
| Viewer F | THCC318 | 56 | Negative |
| Viewer F | THCC493 | રે રેણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, આંગ | Negative |

Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons for the devices. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Summary results are shown below.

# The results summary for strip format:

| % of Cutoff | Number of<br>samples | Drug Concentration<br>by<br>LC/MS/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of<br>Positive | No. of<br>Negative | correct results<br>(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25.3 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 40.1 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 65 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 79 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 93 | 20 | 0 | 100 |

The results summary for dip card format:

| % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay person Results | | The percentage of correct results (%) |
|--------------|-------------------|---------------------------------------|--------------------|----|---------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25.3 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 40.1 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 65 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 79 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 93 | 20 | 0 | 100 |

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

- 3. Clinical Studies
Not applicable.

- 11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the device, it's concluded that

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the BIOEASY Marijuana Test Dip Card and BIOEASY Marijuana Test Strip tests are substantially equivalent to the predicate.