Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50

K232732 · Co-Innovation Biotech Co., Ltd. · LDJ · Jan 17, 2024 · Clinical Toxicology

Device Facts

Record IDK232732
Device NameRapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50
ApplicantCo-Innovation Biotech Co., Ltd.
Product CodeLDJ · Clinical Toxicology
Decision DateJan 17, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.3870
Device ClassClass 2

Intended Use

Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL. The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use. The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Device Story

Lateral flow immunochromatographic assay for qualitative detection of Marijuana metabolites in human urine. Device formats include test strips and dipcards. Principle: competitive binding; urine sample migrates via capillary action across membrane pre-coated with Marijuana antigen; antibody-dye conjugate binds to drug if present (preventing colored band at Test Region, indicating positive) or binds to drug-protein conjugate (forming colored band, indicating negative). Performed without instrumentation by lay users in home or point-of-care settings. Results interpreted visually by user. Preliminary positive results require professional confirmation via GC/MS or LC/MS.

Clinical Evidence

No clinical diagnostic studies performed. Evidence consists of analytical performance (precision, cross-reactivity, interference, pH/specific gravity effects) and a lay user study (n=720 total, 360 per cutoff). Lay user study demonstrated high agreement with LC/MS confirmed samples across concentrations (0 to 100% of cutoff).

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Formats: test strip and dipcard. No instrumentation required. Visual readout. Materials include pre-coated membrane and antibody-dye conjugate. Qualitative detection only.

Indications for Use

Indicated for qualitative screening of Marijuana and metabolites in human urine for over-the-counter use. Cut-off concentrations are 20 ng/mL or 50 ng/mL. Provides preliminary results requiring confirmation by 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).

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left, and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. Co-Innovation Biotech Co., Ltd. Hong Feng Product Manager No. 9 Baihe 3 Street Economic And Technological Development East Zone Guangzhou, Guangdong 510530 China ## Re: K232732 Trade/Device Name: Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ Dated: December 11, 2023 Received: December 11, 2023 ## Dear Hong Feng: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ 2 Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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, | |------------| |------------| | Joseph A. Kotarek -S | Digitally signed by Joseph A. Kotarek -S<br>Date: 2024.01.17 17:24:10 -05'00' | |-------------------------------------------------|-------------------------------------------------------------------------------| | Joseph Kotarek | | | Branch Chief | | | Division of Chemistry<br>and Toxicology Devices | | | OHT7: Office of In Vitro Diagnostics | | | Office of Product Evaluation and Quality | | | Center for Devices and Radiological Health | | #### Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K232732 #### Device Name Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 #### Indications for Use (Describe) Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL. The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use. The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Section 5 - 510(k) Summary ## K232732 Date of Summary Preparation: 17/1/2024 #### 1. Submitter's Identifications Submitter: Co-Innovation Biotech Co.,Ltd. Address: No.9 Baihe 3 Street, Economic And Technological Development East Zone , Guangzhou,510530, Guangdong P.R. CHINA Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-82109823 Fax: + 86 -20-82109823 2. Correspondent's Identifications Correspondent's Name: Co-Innovation Biotech Co.,Ltd. Address: No.9 Baihe 3 Street, Economic And Technological Development East Zone , Guangzhou,510530, Guangdong P.R. CHINA Contact Person: Hong Feng Contact Email Address: fenghongfda(@126.com Telephone: + 86 -20-82109823 Fax: + 86 -20-82109823 #### 3. Name of the Device Recommended classification regulation: 21 CFR 862.3870 Cannabinoid test system Device class: ClassII Panel: Toxicology (91) Product code: LDJ Common Name: Cannabinoid (THC) Test System Proprietary names: Rapid Marijuana (THC) Test Strip 20 Rapid Marijuana (THC) Test Dipcard 20 Rapid Marijuana (THC) Test Strip 50 Rapid Marijuana (THC) Test Dipcard 50 #### 4. The Predicate Devices {4}------------------------------------------------ BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, K192515 BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 ### 5. Device Description Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 20 ng/mL. The tests can be performed without the use of an instrument. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Marijuana and their metabolites at or above the cut-off concentration of 50 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures. ### 6. Intended Use of Device Rapid Marijuana (THC) Test Strip 20 and Rapid Marijuana (THC) Test Dipcard 20 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 20 ng/mL. Rapid Marijuana (THC) Test Strip 50 and Rapid Marijuana (THC) Test Dipcard 50 is a rapid, screening test for the qualitative detection of Marijuana and their metabolites in human urine at the cut-off concentration of 50 ng/mL. The tests contain two formats:1) Test Strip and 2) Test Dipcard. The tests are intended for in vitro diagnostics use. They are intended for over-the-counter use. The tests provide only a preliminary result. To obtain a confirmed analytical result, a more specific alternative chemical must be used. Gas Chromatography/Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. ## 7. Comparison to Predicate Devices: A summary comparison of features of the Rapid Marijuana (THC) Test and the predicate devices is provided in the following Table: | Item | Device | Predicate (K192515) | |------|--------|---------------------| |------|--------|---------------------| {5}------------------------------------------------ | Indication for use | Qualitative detection of Marijuana in urine | Same | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------| | Intended Use | Over-the-counter use | Prescription Use | | Specimen | Urine | Same | | Cutoff | 20 ng/mL or 50 ng/mL | 20 ng/mL or 40 ng/mL | | Results | Qualitative | Same | | Methodology | Competitive binding, Lateral flow<br>immunochromatographic assay based<br>on the principle of antigen antibody<br>immunochemistry | Same | | Configuration | Strip and Dipcard | Same | | Platform Required | No | Same | | Storage | 4-30°C | Same | Remark: The subject devices have all features of the predicate device except the Cutoff concentration and Intended Use. ### 8. Performance Data: ## 8.1 Cross-reactivity with structurally similar compounds To test the cross reactivity of the test, 3 lots of test Strip and test Dipcard was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 3 replicates using 3 lots of Strip and test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below. For cut-off 20ng/mL | Compound | Lowest<br>Concentration<br>(ng/mL) | %<br>Cross-reactivity | |--------------------------------------|------------------------------------|-----------------------| | 11-nor-Δ9-THC-9-COOH | 20 | 100% | | 11-nor-Δ8-THC-9-COOH | 20 | 100% | | 11-Nor-Δ9-THC-carboxy<br>glucuronide | 30 | 66.7% | | 11-Hydroxy-Δ | 20 | 100% | {6}------------------------------------------------ | 9-Tetrahydrocannabinol | | | |------------------------------|---------|--------------| | (-)-11-nor-9-carboxy-Δ 9-THC | 20 | 100% | | Δ9-THC | 6000 | 0.3% | | Δ8-THC | 4000 | 0.5% | | Cannabinol | 8000 | 0.3% | | Cannabidiol | >100000 | Not detected | For cut-off 50ng/mL | Compound | Lowest<br>Concentration<br>(ng/mL) | %<br>Cross-reactivity | |----------------------------------------|------------------------------------|-----------------------| | 11-nor-Δ9-THC-9-COOH | 50 | 100% | | 11-nor-Δ8-THC-9-COOH | 50 | 100% | | 11-Nor-Δ9-THC-carboxy<br>glucuronide | 75 | 66.7% | | 11-Hydroxy-Δ9-<br>Tetrahydrocannabinol | 50 | 100.0% | | (-)-11-nor-9-carboxy-Δ9-THC | 50 | 100.0% | | Δ9-THC | 10,000 | 0.5% | | Δ8-THC | 15,000 | 0.3% | | Cannabinol | 20,000 | 0.3% | | Cannabidiol | >100,000 | Not detected | ## 8.2 Interference Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine and target drug (-)-11-nor-9-Carboxy-A2-THC urine with concentrations at 50% below and 50% above Cut-Off levels. All potential interfering substances were added at a concentration of 100μg/mL (albumin was tested at 100 mg/dL and ethanol was tested at 1%). The urine specimens were tested with 3 lots of test Strip and test Dipcard. None of the compounds listed below were shown to interfere. | Acetaminophen | Diphenhydramine | Norethindrone | |----------------------|-----------------------|-----------------| | Acetophenetidin | Ecgonine methyl ester | Noscapine | | N-Acetylprocainamide | Ephedrine | d,l-Octopamine | | Acetylsalicylic acid | ß-Estradiol | Oxalic acid | | Albumin (100 mg/dL) | Erythromycin | Oxolinic acid | | Aminopyrine | Estrone-3-sulfate | Oxymetazoline | | Amoxicillin | Ethanol (1%v/v) | Oxytetracycline | {7}------------------------------------------------ | Co-Innovation Biotech Co.,Ltd. | | | |--------------------------------|--|--| |--------------------------------|--|--| | Ampicillin | Ethyl-p-aminobenzoate | Papaverine | |---------------------|------------------------|----------------------------------------| | Apomorphine | Erythromycin | Penicillin-G | | Ascorbic acid | Fenoprofen | Pentazocine | | Aspartame | Flucloxacillin | Perphenazine | | Aspirin | Fluoxetine | Phenelzine | | Atenolol | Furosemide | Prednisolone | | Atorvastatin | Gentisic acid | Prednisone | | Atropine | Hemoglobin | (±)-Propranolol | | Azlocillin | Hydralazine | d-Pseudoephedrine | | Benzilic acid | Hydrochlorothiazide | Quinacrine | | Benzylpenicillin | Hydrocortisone | Quinine | | Benzoic acid | o-Hydroxyhippuric acid | Quindine | | Bilirubin | 3-Hydroxytyramine | Ranitidine | | Benzydamine | Ibuprofen | Salicylic acid | | Caffeine | Indomethacin | Serotonin | | Carbamazepine | Iproniazid | Sulfamethazine | | Cephalexin | d,l-Isoproterenol | Sulindac | | Chloralhydrate | Isoxsuprine | Tetracycline | | Chloramphenicol | Ketamine | Tetrahydrocortisone 3-(β-Dglucuronide) | | Chlorothiazide | Ketoprofen | Tetrahydrocortisone 3-acetate | | Chlorpheniramine | Labetalol | Tetrahydrozoline | | d,l-Chlorpromazine | Lisinopril | Thiamine | | Cholesterol | Loperamide | Thioridazine | | Clonidine | Meperidine | Tolbutamine | | Cimetidine | Meprobamate | Tolbutamide | | Citalopram | Methoxyphenamine | Triamterene | | Cortisone | Methylphenidate | Trifluoperazine | | (-)-Cotinine | Nadolol | Trimethoprim | | Creatinine | Nalidixic acid | DL-Tryptophan | | Deoxycorticosterone | Naloxone | Tryptamine | | Dexamethasone | Naltrexone | Tyramine | | Dextromethorphan | Naproxen | d, 1-Thyroxine (DL-Tyrosine) | | Diclofenac | Niacinamide | Uric acid | | Diflunisal | Nicotine | Verapamil | | Digoxin | Nifedipine | Zomepirac | #### 8.3 Effect of urinary pH The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with target drug (-)-11-nor-9-Carboxy-Δ2-THC at 50% below and 50% above cutoff levels. Each sample was tested by 3 lots of test Strip and test Dipcard. The results {8}------------------------------------------------ demonstrate that varying ranges of pH do not interfere with the performance of the test. #### 8.4 Effect of Urinary specific gravity The specific gravity studies were conducted on different specific gravity including 1.000, 1.002.1.010. 1.020. 1.030. 1.040 specimens and spiked with target drug (-)-11-nor-9-Carboxy-Δº-THC with concentrations at 50% below and 50% above Cut-Off levels. Each sample was tested by 3 lots of test Strip and test Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result. #### 8.5 Precision Precision studies were performed using 3 lots of test Strip and test Dipcard. Drug free specimens were spiked with target drug (-)-11-nor-9-Carboxy-Δ'-THC at 0, ±75% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with LC/MS. Each concentration of the urine specimen was divided into aliquots. Each aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test strip format and the second operator test dipcard format. There were 1620 observations by 3 sites at 9 concentrations. | Approximat<br>e<br>concentratio<br>n of sample | % of cutoff | Number of<br>determinat<br>ions per<br>lot | Result<br>Lot 1 | | Result<br>Lot 2 | | Result<br>Lot 3 | | |------------------------------------------------|-------------|--------------------------------------------|-----------------|----------|-----------------|----------|-----------------|----------| | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 10ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 15ng/ml | -25%cutoff | 60 | 6 | 54 | 4 | 56 | 4 | 56 | | 20ng/ml | cutoff | 60 | 34 | 26 | 36 | 24 | 32 | 28 | | 25ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 58 | 2 | | 30ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 35ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 40ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | | f | | Positive | Negative | Positive | Negative | Positive | Negative | Rapid Marijuana (THC) Test Strip 20: Rapid Marijuana (THC) Test Dipcard 20: {9}------------------------------------------------ | Approximat<br>e<br>concentratio<br>n of sample | % of cutoff | Number of<br>determinati<br>ons per lot | Result | | | | | | |------------------------------------------------|-----------------|-----------------------------------------|----------|--------------|--------------|--------------|--------------|--------------| | | | | Lot 1 | | Lot 2 | | Lot 3 | | | | | | Positive | Negativ<br>e | Positiv<br>e | Negativ<br>e | Positiv<br>e | Negativ<br>e | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 10ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 15ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 4 | 56 | | 20ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 | | 25ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 | | 30ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 35ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 40ng/ml | +100%cuto<br>ff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | Rapid Marijuana (THC) Test Strip 50: | Approximat<br>e<br>concentratio<br>n of sample | % of cutoff | Number of<br>determinat<br>ions per<br>lot | Result | | | | | | |------------------------------------------------|-------------|--------------------------------------------|----------|----------|----------|----------|----------|----------| | | | | Lot 1 | Lot 2 | Lot 3 | | | | | | | | Positive | Negative | Positive | Negative | Positive | Negative | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 37.5ng/ml | -25%cutoff | 60 | 4 | 56 | 6 | 54 | 2 | 58 | | 50ng/ml | cutoff | 60 | 36 | 24 | 38 | 22 | 34 | 26 | | 62.5ng/ml | +25%cutoff | 60 | 56 | 4 | 56 | 4 | 58 | 2 | | 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | Rapid Marijuana (THC) Test Dipcard 50: | Approximat<br>e<br>concentratio<br>n of sample | % of cutoff | Number of<br>determinations per lot | Result | | | | | | |------------------------------------------------|-------------|-------------------------------------|----------|----------|----------|----------|----------|----------| | | | | Lot 1 | Lot 2 | Lot 3 | | | | | | | | Positive | Negative | Positive | Negative | Positive | Negative | | 0ng/ml | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 12.5ng/ml | -75%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 25ng/ml | -50%cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 | | 37.5ng/ml | -25%cutoff | 60 | 6 | 54 | 2 | 58 | 6 | 54 | | 50ng/ml | cutoff | 60 | 38 | 22 | 34 | 26 | 36 | 24 | {10}------------------------------------------------ | 62.5ng/ml | +25%cutoff | 60 | 58 | 2 | 56 | 4 | 54 | 6 | |-----------|-------------|----|----|---|----|---|----|---| | 75ng/ml | +50%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 87.5ng/ml | +75%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | | 100ng/ml | +100%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 | #### 8.6 Accuracy 80 clinical urine specimens were analyzed by LC/MS and by 3 lots of Rapid Marijuana (THC) Test Strip and Rapid Marijuana (THC) Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Results were as follows: Rapid Marijuana (THC) Test Strip 20: | Operator | Co-Innovation<br>Result | LC/MS Analysis | | | | Total | | |----------|-------------------------|---------------------|------------------------|----------------------------------------------|----------------------------------------------|-------|------------------------| | | | Neg.<br>(drug free) | Neg. (<<br>-50%cutoff) | Near cutoff<br>neg.(-50%cutoff<br>to cutoff) | Near cutoff<br>pos. (cutoff<br>to+50%cutoff) | | Pos. (><br>+50%cutoff) | | Site1 | Positive | 0 | 0 | 1 | 8 | 31 | 80 | | | Negative | 27 | 5 | 7 | 1 | 0 | | | Site2 | Positive | 0 | 0 | 1 | 8 | 31 | 80 | | | Negative | 27 | 5 | 7 | 1 | 0 | | | Site3 | Positive | 0 | 0 | 1 | 8 | 31 | 80 | | | Negative | 27 | 5 | 7 | 1 | 0 | | Analysis of Discordant Results Rapid Marijuana (THC) Test Strip 20 | Rapid Marijuana (THC) Test Strip 20 | | | LC/MS Analysis | | |-------------------------------------|---------------|----------------|----------------------------------|-----------------------------| | Operator | Cutoff(ng/mL) | Test<br>Result | Drug<br>Concentration<br>(ng/mL) | Drug in Urine | | Site 1 | 20 | Positive | 15.8 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 20 | Negative | 23.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 2 | 20 | Positive | 15.8 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 20 | Negative | 23.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 3 | 20 | Positive | 15.8 | (-)-11-nor-9-Carboxy-Δ9-THC | {11}------------------------------------------------ | 20 | Negative | 23.6 | (-)-11-nor-9-Carboxy- $\Delta^9$ -THC | |----|----------|------|---------------------------------------| |----|----------|------|---------------------------------------| ## Rapid Marijuana (THC) Test Dipcard 20: | Operator | Co-Innovation<br>Result | Neg.<br>(drug free) | Neg. (<<br>-50%cutoff) | Near cutoff<br>neg.(-50%cutoff<br>to cutoff) | Near cutoff<br>pos. (cutoff<br>to+50%cutoff) | Pos. (><br>+50%cutoff) | Total | |----------|-------------------------|---------------------|------------------------|----------------------------------------------|----------------------------------------------|------------------------|-------| | Site1 | Positive | 0 | 0 | 1 | 8 | 31 | 80 | | | Negative | 27 | 5 | 7 | 1 | 0 | | | Site2 | Positive | 0 | 0 | 1 | 8 | 31 | 80 | | | Negative | 27 | 5 | 7 | 1 | 0 | | | Site3 | Positive | 0 | 0 | 1 | 8 | 31 | 80 | | | Negative | 27 | 5 | 7 | 1 | 0 | | Analysis of Discordant Results Rapid Marijuana (THC) Test Dipcard 20 | Rapid Marijuana (THC) Test Dipcard<br>20 | | | LC/MS Analysis | | |------------------------------------------|---------------|-------------|-------------------------------|-----------------------------| | Operator | Cutoff(ng/mL) | Test Result | Drug Concentration<br>(ng/mL) | Drug in Urine | | Site 1 | 20 | Positive | 15.8 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 20 | Negative | 23.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 2 | 20 | Positive | 15.8 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 20 | Negative | 23.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 3 | 20 | Positive | 15.8 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 20 | Negative | 23.6 | (-)-11-nor-9-Carboxy-Δ9-THC | Rapid Marijuana (THC) Test Strip 50: | | | LC/MS Analysis | | | | | Total | |----------|-------------------------|----------------------|------------------------|----------------------------------------------|----------------------------------------------|------------------------|-------| | Operator | Co-Innovation<br>Result | Neg.<br>(drug free ) | Neg. (<<br>-50%cutoff) | Near cutoff<br>neg.(-50%cutoff<br>to cutoff) | Near cutoff<br>pos. (cutoff<br>to+50%cutoff) | Pos. (><br>+50%cutoff) | | | Site1 | Positive | 0 | 0 | 1 | 9 | 30 | 80 | | | Negative | 21 | 10 | 8 | 1 | 0 | | {12}------------------------------------------------ | Site2 | Positive | 0 | 0 | 1 | 9 | 30 | 80 | |-------|----------|----|----|---|---|----|----| | | Negative | 21 | 10 | 8 | 1 | 0 | | | Site3 | Positive | 0 | 0 | 1 | 9 | 30 | 80 | | | Negative | 21 | 10 | 8 | 1 | 0 | | Analysis of Discordant Results Rapid Marijuana (THC) Test Strip 50 | Rapid Marijuana (THC) Test Strip 50 | | | LC/MS Analysis | | |-------------------------------------|---------------|-------------|----------------------------|-----------------------------| | Operator | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine | | Site 1 | 50 | Positive | 41.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 50 | Negative | 60.2 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 2 | 50 | Positive | 41.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 50 | Negative | 60.2 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 3 | 50 | Positive | 41.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 50 | Negative | 60.2 | (-)-11-nor-9-Carboxy-Δ9-THC | Rapid Marijuana (THC) Test Dipcard 50: | Operator | Co-Innovation<br>Result | LC/MS Analysis | | | | | Total | |----------|-------------------------|---------------------|------------------------|----------------------------------------------|----------------------------------------------|------------------------|-------| | | | Neg.<br>(drug free) | Neg. (<<br>-50%cutoff) | Near cutoff<br>neg.(-50%cutoff<br>to cutoff) | Near cutoff<br>pos. (cutoff<br>to+50%cutoff) | Pos. (><br>+50%cutoff) | | | Site1 | Positive | 0 | 0 | 1 | 9 | 30 | 80 | | | Negative | 21 | 10 | 8 | 1 | 0 | | | Site2 | Positive | 0 | 0 | 1 | 9 | 30 | 80 | | | Negative | 21 | 10 | 8 | 1 | 0 | | | Site3 | Positive | 0 | 0 | 1 | 9 | 30 | 80 | | | Negative | 21 | 10 | 8 | 1 | 0 | | Analysis of Discordant Results Rapid Marijuana (THC) Test Dipcard 50 | Rapid Marijuana (THC) Test Dipcard<br>50 | | | LC/MS Analysis | | |------------------------------------------|-------------------|-------------|----------------------------------|---------------| | Operator | Cutoff(ng/m<br>L) | Test Result | Drug<br>Concentration<br>(ng/mL) | Drug in Urine | {13}------------------------------------------------ | Site 1 | 50 | Positive | 41.6 | (-)-11-nor-9-Carboxy-Δ9-THC | |--------|----|----------|------|-----------------------------| | | 50 | Negative | 60.2 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 2 | 50 | Positive | 41.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 50 | Negative | 60.2 | (-)-11-nor-9-Carboxy-Δ9-THC | | Site 3 | 50 | Positive | 41.6 | (-)-11-nor-9-Carboxy-Δ9-THC | | | 50 | Negative | 60.2 | (-)-11-nor-9-Carboxy-Δ9-THC | ## 8.7 Home Use Consumer Study 180 lay users from age 18 to 65 years participated in the study. Urine samples were prepared at the following concentrations: 0, +/- 50% cutoff and +100% cutoff and +100% cutoff by spiking target drug (-)-11-nor-9-Carboxy-A2-THC into drug free urine specimens. Each sample contain different drugs and the different concentrations. The concentrations of target drugs were confirmed with LC/MS. Each participant performed only 1 test on provided specimen with one format of Rapid Marijuana (THC) Test (Strip, Dipcard) using the English package insert as guide to perform the test. They were asked to fill out an English questionnaire after finishing the test. Results were as follows: Rapid Marijuana (THC) Test Strip 20: | Approximate<br>concentration<br>of sample | % of cutoff | Number of<br>determinations per lot | Layer user Results | | Agreement<br>(%) | |-------------------------------------------|-------------|-------------------------------------|--------------------|----|------------------| | 0ng/ml | Negative | 30 | 0 | 30 | 100% | | 10ng/ml | -50%cutoff | 30 | 0 | 30 | 100% | | 15ng/ml | -25%cutoff | 30 | 2 | 28 | 93% | | 25ng/ml | +25%cutoff | 30 | 27 | 3 | 90% | | 30ng/ml | +50%cutoff | 30 | 30 | 0 | 100% | | 40ng/ml | +100%cutoff | 30 | 30 | 0 | 100% | Rapid Marijuana (THC) Test Dipcard 20: | Approximate<br>concentration<br>of sample | % of cutoff | Number of<br>determinations per lot | Layer user Results | | Agreement<br>(%) | |-------------------------------------------|-------------|-------------------------------------|--------------------|----|------------------| | 0ng/ml | Negative | 30 | 0 | 30 | 100% | | 10ng/ml | -50%cutoff | 30 | 0 | 30 | 100% | | 15ng/ml | -25%cutoff | 30 | 3 | 27 | 90% | | 25ng/ml | +25%cutoff | 30 | 28 | 2 | 93% | | 30ng/ml | +50%cutoff | 30 | 30 | 0 | 100% | | 40ng/ml | +100%cutoff | 30 | 30 | 0 | 100% | Rapid Marijuana (THC) Test Strip 50: {14}------------------------------------------------ | Approximate<br>concentration<br>of sample | % of cutoff | Number of<br>determinations per lot | Layer user Results | | Agreement<br>(%) | |-------------------------------------------|-------------|-------------------------------------|--------------------|----|------------------| | 0ng/ml | Negative | 30 | 0 | 30 | 100% | | 25ng/ml | -50%cutoff | 30 | 0 | 30 | 100% | | 37.5ng/ml | -25%cutoff | 30 | 1 | 29 | 97% | | 62.5ng/ml | +25%cutoff | 30 | 28 | 2 | 93% | | 75ng/ml | +50%cutoff | 30 | 30 | 0 | 100% | | 100ng/ml | +100%cutoff | 30 | 30 | 0 | 100% | Rapid Marijuana (THC) Test Dipcard 50: | Approximate<br>concentration<br>of sample | % of cutoff | Number of<br>determinations per lot | Layer user Results | | Agreement<br>(%) | |-------------------------------------------|-------------|-------------------------------------|--------------------|----------|------------------| | | | | Positive | Negative | | | 0ng/ml | Negative | 30 | 0 | 30 | 100% | | 25ng/ml | -50%cutoff | 30 | 0 | 30 | 100% | | 37.5ng/ml | -25%cutoff | 30 | 2 | 28 | 93% | | 62.5ng/ml | +25%cutoff | 30 | 28 | 2 | 93% | | 75ng/ml | +50%cutoff | 30 | 30 | 0 | 100% | | 100ng/ml | +100%cutoff | 30 | 30 | 0 | 100% | 180 questionnaires were distributed collected. The results show that the test is easy to be used and the instruction insert is clear. ## Evaluation of the readability of the labeling The entire package insert readability was assessed. We choose 30 chain sentences from Instructions Insert at OTC user read. The numbers of polysyllabic words are 10 words. According to SMOG Conversion Table of Appendix B the SMOG Readability Formula of "Labeling of Home-Use In Vitro Testing Products: Approved Guideline: GP-14A5", the reading level belong to 6 degree. ## 9. Conclusion: The data collected in the performance and accuracy studies demonstrate that the Rapid Marijuana (THC) Test are substantially equivalent to the predicate device. --- End of this section ---
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