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.

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.

AI/ML Overview

This document describes the performance characteristics and acceptance criteria for the BIOEASY Marijuana Test Dip Card and BIOEASY Marijuana Test Strip.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay devices like these are typically based on achieving a certain level of agreement with a reference method (LC/MS in this case) across different concentration ranges relative to the cutoff, and demonstrating reliable performance under various conditions.

Since the document does not explicitly state "acceptance criteria" numerical targets, these are inferred from the presented data, aiming for high agreement, especially at concentrations away from the cutoff, and demonstrating appropriate performance near the cutoff.

Performance Characteristic	Acceptance Criteria (Inferred)	Reported Device Performance (BIOEASY Marijuana Test Dip Card / Strip)
Precision	High agreement (ideally 100% Negative or 100% Positive) for samples far from the cutoff (-100%, -75%, -50% cut off; +50%, +75%, +100% cut off). Acceptable distribution of results (both positive and negative) for samples at the cutoff (50 ng/mL), reflecting the qualitative nature and inherent variability around the cutoff.	Dip Card: -100% to -25% Cutoff: 100% Negative (200/200 total per lot). +25% to +100% Cutoff: 100% Positive (200/200 total per lot). At Cutoff: Mixture of Positive/Negative (25-/25+, 23-/27+, 24-/26+ for Lot 1, 2, 3 respectively). Strip: -100% to -25% Cutoff: 100% Negative (200/200 total per lot). +25% to +100% Cutoff: 100% Positive (200/200 total per lot). At Cutoff: Mixture of Positive/Negative (19-/31+, 28-/22+, 23-/27+ for Lot 1, 2, 3 respectively).
Specificity	No interference from common physiological and pathological substances found in urine. Limited or no cross-reactivity with structurally similar compounds at high concentrations, or clear explanation of cross-reactivity at specified concentrations.	Interference: No interference observed at specified concentrations for a wide range of common substances (e.g., albumin, ethanol, acetaminophen, ibuprofen).Cross-Reactivity: 100% to 11-nor-Δ9-THC-9-COOH, 11-Hydroxy-Δ9-Tetrahydrocannabinol, 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH, (-)-11-nor-9-carboxy-Δ9-THC at 50 ng/mL.Lower cross-reactivity for Cannabinol (0.25%), Δ8-Tetrahydrocannabinol (0.33%), Δ9-Tetrahydrocannabinol (0.33%) at significantly higher concentrations (15000-20000 ng/mL). Cannabidiol (<0.05% at >100000 ng/mL). 11-Nor-Δ9-THC-carboxy glucuronide (66.7% at 75 ng/mL).
Effect of Urine SG & pH	Reliable performance (correct result relative to cutoff) across a range of urine specific gravity (SG) and pH values.	Specific Gravity: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off for SG range of 1.000 to 1.035.pH: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off for pH range of 4 to 9.
Method Comparison (Analytical Accuracy)	High agreement with LC/MS (gold standard) for samples categorized as "Negative," "Low Negative," "High Positive." A reasonable number of discordant results are expected at "Near Cutoff" concentrations, reflecting the inherent variability of qualitative assays around the cutoff.	Strip Format: Negative, Low Negative, High Positive LC/MS categories show high agreement across viewers (e.g., Viewer A: 6/6 Negatives, 14/14 Low Negatives, 18/18 High Positives).Near Cutoff Negative and Positive categories show some discordance (e.g., Viewer A: 1 Positive out of 20 Near Cutoff Negatives, 1 Negative out of 22 Near Cutoff Positives).Dip Card Format: Similar high agreement for clear negative/positive samples and expected discordance near cutoff.
Lay-User Study Performance	High percentage of correct results when used by lay persons, demonstrating ease of use and interpretability of results as per the Instructions For Use (IFU). Acceptable performance around the cutoff. User surveys confirm ease of understanding IFU.	Strip & Dip Card: -100%, -75%, -50% Cutoff: 100% correct results.-25% Cutoff: 95% (Strip) and 90% (Dip Card) correct results (1-2 false positives out of 20).+25% Cutoff: 90% correct results (2 false negatives out of 20).+50%, +75% Cutoff: 100% correct results.Lay-user surveys: All users indicated instructions were easily followed (Grade Level 7 Flesch-Kincaid).
Stability	Devices remain stable and perform within acceptance criteria over the claimed shelf-life under specified storage conditions.	Stable at 4-30 ℃ for 24 months based on accelerated stability at 45 ℃ and real-time stability at 4 ℃ and 30 ℃.

2. Sample Sizes Used for the Test Set and Data Provenance

Precision Studies:
- For each of the 8 concentration points (ranging from -100% of cutoff to +100% of cutoff) relative to the 50 ng/mL cutoff, 50 tests were performed per concentration point for each of the 3 lots.
- Total tests for Precision: 8 concentrations x 50 tests/concentration x 3 lots = 1200 tests per device format (Dip Card and Strip).
- Data Provenance: Samples were "prepared by spiking 11-Nor-△9-THC-9-COOH in negative samples." The document does not specify the country of origin but implies laboratory-prepared samples. It's a prospective study on prepared samples.
Interference Studies:
- Tested at 25% below and 25% above cutoff with various interfering substances.
- "Three batches of each device" were used. The number of samples for each interfering substance is not explicitly stated but implied to be sufficient for testing.
Specificity Studies (Cross-Reactivity):
- Various drug metabolites and other components were tested.
- "Three batches of each device format" were used. The number of tests per compound is not explicitly stated.
Effect of Urine Specific Gravity and pH:
- Tested at 25% below and 25% above cutoff with varying SG and pH.
- "Three lots of each device format" were used. The number of samples per condition is not explicitly stated.
Method Comparison Studies (Analytical Accuracy):
- 80 "unaltered clinical samples" were used for each device format (40 negative and 40 positive).
- Data Provenance: "Clinical samples." No country of origin is specified. The study is retrospective in the sense that samples were collected and then tested.
Lay-User Study:
- 280 lay persons participated.
- 7 concentration points were tested (negative, +/-75%, +/-50%, +/-25% of the cutoff).
- For each concentration point, 20 samples were tested.
- Total tests: 7 concentrations x 20 samples/concentration = 140 samples per device format.
- Data Provenance: Urine samples were "prepared by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens." The location of the lay-user study is described as "three intended user sites," but no specific country is mentioned. This is a prospective study on prepared samples with lay users.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Analytical Ground Truth:
- For the precision, interference, specificity, and lay-user studies, the ground truth for spiked samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is a highly accurate and specific analytical method.
- For the method comparison study, "LC/MS results" were used as the gold standard for classifying clinical samples.
- No human experts were explicitly "establishing" ground truth in terms of diagnostic interpretation; rather, the ground truth was based on the objective, quantitative results of LC/MS.

4. Adjudication Method for the Test Set

Analytical Studies (Precision, Interference, Specificity, SG/pH): No adjudication method is mentioned or needed as the results are quantitative and read as positive/negative based on the device's qualitative nature. The preparation and blinding for precision studies suggest a robust method.
Method Comparison Study: The document states, "Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results." "Viewer A, B, C" for the strip and "Viewer D, E, F" for the dip card were the "laboratory assistants." The data are presented per viewer, implying individual results were compared to LC/MS. There is no mention of an adjudication process for discordant results among the viewers or between the device results and LC/MS. The discordant results are simply listed.
Lay-User Study: No adjudication. The results are presented as the "No. of Positive" and "No. of Negative" given by the lay persons, compared to the known spiked concentration verified by LC/MS.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This document describes the validation of a qualitative in-vitro diagnostic device (Marijuana Test Dip Card/Strip) for detecting Marijuana in urine directly by human observation of lines on a test strip/card. There is no AI component involved, so no study on AI assistance or human reader improvement with AI can be conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manual, visually read immunoassay. There is no algorithm or automated reading component. The "standalone" performance is simply the device's ability to produce a correct result when used as intended and read by a human. The "Method Comparison Studies" and "Precision Studies" essentially demonstrate the standalone performance of the device itself (though still read by human operators).

7. The Type of Ground Truth Used

The primary ground truth used for all performance studies (precision, method comparison, lay-user study) was analytical confirmation by LC/MS (Liquid Chromatography/Mass Spectrometry). This is considered a gold standard for quantitative drug concentration measurement.
For interference and specificity, the ground truth was based on the known presence/absence and concentration of the spiked substances.

8. The Sample Size for the Training Set

This document describes performance validation studies for a medical device (Marijuana Test Dip Card/Strip). These types of devices are not typically "trained" in the machine learning sense. Therefore, there is no "training set" in the context of an AI/ML model for this device. The data presented are for demonstrating the device's analytical and clinical performance.

9. How the Ground Truth for the Training Set Was Established

As there is no AI/ML component and thus no "training set," this question is not applicable. The ground truth for the test samples (used for validation) was established using LC/MS.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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.

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: 240-505-7880 Email: shiajl@yahoo.com
1. Device Name: BIOEASY Marijuana Test Dip Card BIOEASY Marijuana Test Strip

Classification: Class 2

Product Code	Classification	Regulation Section	Panel
NFWCannabinoids	II	21 CFR § 862.3870, CannabinoidsTest System	Toxicology (91)

1. Predicate Devices: K182530
  The Bioeasy Multi-Drug Test Cup
1. 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.

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.

For in vitro diagnostic use only.

1. 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

1. 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)for Use	For the qualitative determination ofmarijuana in human urine.	Same (but the number ofdrugs detected is different)
Calibrator and Cut-OffValues	11-Nor-Δ9-THC-9-COOH50 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	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.

LotNumber	-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+	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)(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.

1. 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	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	21	18
	Negative	6	14	19	1	0
ViewerB	Positive	0	0	1	20	18
	Negative	6	14	19	2	0
ViewerC	Positive	0	0	2	21	18
	Negative	6	14	18	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	BIOEASYResults
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	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+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	BIOEASYResults
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 ofsamples	Drug ConcentrationbyLC/MS/MS(ng/mL)	Lay person Results		The percentage of
			No. ofPositive	No. ofNegative	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	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.

1. Clinical Studies
  Not applicable.
1. 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.

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
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 includedelta -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.(b)
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).