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.

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.

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.

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

Here's an analysis of the provided document to extract the acceptance criteria and study details:

Device: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (Cannabinoid test system)

Indications for Use: Qualitative detection of Marijuana (THC) in human urine at cutoff concentrations of 20 ng/mL or 40 ng/mL. Provides preliminary test results, requiring GC/MS or LC/MS for confirmation. For in vitro diagnostic use only.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics that collectively demonstrate acceptable performance for substantial equivalence. The precision studies, in particular, provide detailed performance around the cut-off concentrations, which are key to evaluating the device.

Based on the precision data, the performance of the device is evaluated against its ability to correctly identify positive and negative samples at various concentrations relative to the cutoff. The data suggests that at -25% to +25% of the cutoff concentration, there is variability, but at concentrations definitively below (-50% or less) or above (+50% or more) the cutoff, the device shows 100% agreement with the expected outcome.

Here's a summary derived from the precision study results:

Performance Metric (Derived from Precision Study)	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Precision (at 20 ng/mL Cut-off)
Negatives (-75% to -100% cutoff)	100% negative results	Dip Card 20ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off. Strip 20ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off.
Positives (+75% to +100% cutoff)	100% positive results	Dip Card 20ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off. Strip 20ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off.
Near Cutoff (-25%)	Majority negative, some positive acceptable (demonstrates functionality near threshold)	Dip Card 20ng/mL: Lot 1: 58-/2+, Lot 2: 59-/1+, Lot 3: 59-/1+ (Total 176-/4+). Strip 20ng/mL: Lot 1: 59-/1+, Lot 2: 58-/2+, Lot 3: 59-/1+ (Total 176-/4+).
Near Cutoff (+25%)	Majority positive, some negative acceptable (demonstrates functionality near threshold)	Dip Card 20ng/mL: Lot 1: 59+/1-, Lot 2: 59+/1-, Lot 3: 58+/2- (Total 176+/4-). Strip 20ng/mL: Lot 1: 58+/2-, Lot 2: 58+/2-, Lot 3: 57+/3- (Total 173+/7-).
At Cutoff	Approximately 50% positive, 50% negative (demonstrates accurate cutoff performance)	Dip Card 20ng/mL: Lot 1: 32-/28+, Lot 2: 29-/31+, Lot 3: 30-/30+ (Overall close to 50/50 split). Strip 20ng/mL: Lot 1: 30-/30+, Lot 2: 32-/28+, Lot 3: 31-/29+ (Overall close to 50/50 split).
Precision (at 40 ng/mL Cut-off)
Negatives (-75% to -100% cutoff)	100% negative results	Dip Card 40ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off. Strip 40ng/mL: 100% negative (180-/0+) for -100%, -75%, -50% cut-off.
Positives (+75% to +100% cutoff)	100% positive results	Dip Card 40ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off. Strip 40ng/mL: 100% positive (180+/0-) for +75%, +100% cut-off.
Near Cutoff (-25%)	Majority negative, some positive acceptable	Dip Card 40ng/mL: Lot 1: 59-/1+, Lot 2: 57-/3+, Lot 3: 58-/2+ (Total 174-/6+). Strip 40ng/mL: Lot 1: 58-/2+, Lot 2: 59-/1+, Lot 3: 58-/2+ (Total 175-/5+).
Near Cutoff (+25%)	Majority positive, some negative acceptable	Dip Card 40ng/mL: Lot 1: 58+/2-, Lot 2: 59+/1-, Lot 3: 59+/1- (Total 176+/4-). Strip 40ng/mL: Lot 1: 59+/1-, Lot 2: 57+/3-, Lot 3: 58+/2- (Total 174+/6-).
At Cutoff	Approximately 50% positive, 50% negative	Dip Card 40ng/mL: Lot 1: 31-/29+, Lot 2: 28-/32+, Lot 3: 29-/31+ (Overall close to 50/50 split). Strip 40ng/mL: Lot 1: 32-/28+, Lot 2: 29-/31+, Lot 3: 31-/29+ (Overall close to 50/50 split).
Analytical Specificity (Cross-Reactivity)	Detect THC and its main metabolites. Limited cross-reactivity with other substances (ideally <1%).	THC related: 11-nor-Δ9-THC-9-COOH, 11-Hydroxy-Δ9-Tetrahydrocannabinol, 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH, (-)-11-nor-9-carboxy-Δ9-THC all show 100% cross-reactivity at the cutoff. Cannabinol: 0.25% cross-reactivity. Δ8-Tetrahydrocannabinol, Δ9-Tetrahydrocannabinol: 0.33% cross-reactivity. Cannabidiol: <0.02% (20ng/mL) / <0.04% (40ng/mL) cross-reactivity. 11-Nor-Δ9-THC-carboxy glucuronide: 66.7% cross-reactivity.
Interference	No interference from common substances in urine at tested concentrations.	No differences observed for both strip and dip card formats at both cut-offs from a wide range of common substances (e.g., Acetaminophen, Ibuprofen, Albumin, Ethanol, etc.) added to drug-free and target drug urine samples.
Effect of Urine Specific Gravity and pH	No change in results for urine samples with pH 4 to 9 or specific gravity 1.000 to 1.035.	All positive for samples >= +50% Cut-Off and all negative for samples <= -50% Cut-Off for both device formats and cut-offs.
Method Comparison (LC/MS agreement)	High agreement (e.g., >95%) for clearly positive/negative samples, some discordance expected near cutoff relative to the confirmatory method.	Dip Card & Strip 20ng/mL: For each of 3 operators, out of 80 samples (40 neg, 40 pos): - 6 Negative clinical samples: 6/6 Negative (100%) - 16 Low Negative clinical samples: 16/16 Negative (100%) - 20 High Positive clinical samples: 20/20 Positive (100%) - Near Cutoff Negative (15-16 samples): ~15/16 Negative, with 2-3 Positive discordant. - Near Cutoff Positive (18-19 samples): ~18/19 Positive, with 1-2 Negative discordant. Dip Card & Strip 40ng/mL: Similar high agreement at clear negative/positive ranges.

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

Precision Study (Analytical Performance):

Sample Size: For each concentration level (e.g., -100% cutoff, +25% cutoff, etc.), tests were performed six runs per day for 10 days per device lot, and there were three device lots.
- This equates to 6 runs/day * 10 days * 3 lots = 180 tests for each concentration level (e.g., 180 tests at -100% cut-off, 180 tests at +25% cut-off, etc.). There are 9 concentration levels, so theoretically 1,620 tests for each device type (Dip Card 20, Strip 20, Dip Card 40, Strip 40).
Data Provenance: Samples were prepared by spiking 11-Nor-Δ9-THC-9-COOH in negative samples. These appear to be spiked laboratory samples, not clinical samples from a specific country or population. The study is prospective in execution once samples are prepared.

Method Comparison Study:

Sample Size: 80 "unaltered clinical samples" were used for each device format (Dip Card 20, Strip 20, Dip Card 40, Strip 40). These 80 samples consisted of 40 negative and 40 positive samples.
Data Provenance: The samples were described as "unaltered clinical samples." The country of origin is not specified but it's an "in-house" study, suggesting it was conducted by the manufacturer or a laboratory they contracted. The study is retrospective as it uses pre-collected clinical samples.

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

Precision Study:

Ground Truth Establishment: The ground truth for the spiked samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly accurate analytical method.
Number of Experts/Qualifications: The document does not specify "experts" in the traditional sense of human readers. The "ground truth" here is the LC/MS result, which is an objective chemical measurement. The person who prepared the samples (spiking them) and confirmed concentrations by LC/MS was different from the person who tested them to ensure blinding. No specific qualifications are given for these individuals, but it implies laboratory personnel competent in preparing and analyzing such samples.

Method Comparison Study:

Ground Truth Establishment: The ground truth for the clinical samples was established by LC/MS results.
Number of Experts/Qualifications: Similar to the precision study, the ground truth is an objective chemical measurement (LC/MS), not a human expert interpretation of the device's results.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for both the precision and method comparison studies relies on LC/MS as the objective standard. The device's results are compared directly to the LC/MS results. There is no mention of human-based adjudication for ground truth establishment. For the method comparison study, three laboratory assistants performed the readings, and their individual results were compared to LC/MS, but this is a comparison to a known truth, not an adjudication process to establish the truth itself.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly performed as described for AI vs. human readers. The study involves multiple operators (three laboratory assistants) reading multiple cases (80 clinical samples each) in the "Comparison Studies" section. However, this is a comparison of the device's standalone performance (as read by laboratory assistants) against a gold standard (LC/MS), not a study to evaluate human readers' improvement with AI assistance versus without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire set of performance characteristics outlined (Precision, Specificity, Interference, Effect of Urine Specific Gravity and pH, and Comparison Studies) represents the standalone performance of the BIOEASY Marijuana Test devices.

The "Comparison Studies" explicitly show the device's results (as interpreted by laboratory assistants) compared against the LC/MS ground truth, demonstrating its accuracy without human-in-the-loop intervention for decision making beyond reading the visual result.

7. Type of Ground Truth Used

The type of ground truth used is objective chemical analysis (LC/MS).

For the precision studies, 11-Nor-Δ9-THC-9-COOH was spiked into negative samples at known concentrations, and these concentrations were confirmed by LC/MS.
For the method comparison studies, the "unaltered clinical samples" were independently analyzed by LC/MS to establish their true drug concentration.

8. Sample Size for the Training Set

The document describes the device as an "immunochromatographic assay," which is a biochemical test, not an AI or machine learning device. Therefore, there is no training set in the context of machine learning. The device's performance is based on its chemical reactions and design.

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

As the device is not an AI/machine learning product, there is no "training set" and thus no ground truth establishment for a training set in this context.

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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

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

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.

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.

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.

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

Prescription Use (Part 21 CFR 201 Subpart D)
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.No.2-1, Liuxian 1st RoadBaoan DistrictShenzhen, China 518101
3. Contact person:	Joe ShiaLSI International Inc.504E Diamond Ave., Suite IGaithersburg, MD 20877Telephone: 240-505-7880Email: shiajl@yahoo.com
4. Device Name:	BIOEASY Marijuana Test Dip Card 20BIOEASY Marijuana Test Strip 20BIOEASY Marijuana Test Dip Card 40BIOEASY 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

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

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.

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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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.

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 aluminum pouch
1. 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)20 ng/mlor 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

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	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

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	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

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	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)(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)(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	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%)
Operator	Positive	0	0	2	18	20

Strip Format of 20ng/mL Cut-off

{8}------------------------------------------------

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	BIOEASYResults
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	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%)
OperatorD	Positive	0	0	2	18	20
	Negative	6	16	16	2	0
OperatorE	Positive	0	0	2	19	20
	Negative	6	16	16	1	0
OperatorF	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 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%)
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	BIOEASYResults
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 byLC/MS(less than-50%)	Near Cutoff Negative byLC/MS(Between-50% andcutoff)	Near Cutoff Positive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+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.

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).