(132 days)
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.
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.
This document describes the performance of the Rapid Marijuana (THC) Test Strip and Dipcard devices, available in 20 ng/mL and 50 ng/mL cutoff concentrations, for the qualitative detection of Marijuana and its metabolites in human urine.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of specific performance metrics (e.g., minimum sensitivity, specificity, or agreement percentages for accuracy studies). However, the performance data presented implies a standard of acceptable qualitative detection around the cutoff concentration. The precision and accuracy studies evaluate the device's ability to correctly identify positive and negative samples at various concentrations relative to the cutoff. The home-use study assesses user comprehension and ease of use.
Since no explicit numerical acceptance criteria are provided, I will present key performance indicators from the precision and accuracy studies. For the purpose of this table, I will infer that a high percentage of correct classifications at and around the cutoff, along with 100% correct classification for samples significantly above or below the cutoff, would be considered acceptable.
Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 20 ng/mL:
| Performance Metric | Implied Acceptance Criteria (Inferred from data presentation) | Rapid Marijuana (THC) Test Strip 20 Reported Performance (Positive/Negative counts at specified concentrations across 3 lots) | Rapid Marijuana (THC) Test Dipcard 20 Reported Performance (Positive/Negative counts at specified concentrations across 3 lots) |
|---|---|---|---|
| Precision Study | For -75% Cutoff (5 ng/mL): 100% Negative calls or very close | Lot 1: 0 positive, 60 negativeLot 2: 0 positive, 60 negativeLot 3: 0 positive, 60 negative | Lot 1: 0 positive, 60 negativeLot 2: 0 positive, 60 negativeLot 3: 0 positive, 60 negative |
| For -50% Cutoff (10 ng/mL): 100% Negative calls or very close | Lot 1: 0 positive, 60 negativeLot 2: 0 positive, 60 negativeLot 3: 0 positive, 60 negative | Lot 1: 0 positive, 60 negativeLot 2: 0 positive, 60 negativeLot 3: 0 positive, 60 negative | |
| For -25% Cutoff (15 ng/mL): Predominantly Negative calls, some positive possible | Lot 1: 6 positive, 54 negativeLot 2: 4 positive, 56 negativeLot 3: 4 positive, 56 negative | Lot 1: 4 positive, 56 negativeLot 2: 6 positive, 54 negativeLot 3: 4 positive, 56 negative | |
| For Cutoff (20 ng/mL): Mix of Positive and Negative calls (around 50% for each) | Lot 1: 34 positive, 26 negativeLot 2: 36 positive, 24 negativeLot 3: 32 positive, 28 negative | Lot 1: 36 positive, 24 negativeLot 2: 38 positive, 22 negativeLot 3: 34 positive, 26 negative | |
| For +25% Cutoff (25 ng/mL): Predominantly Positive calls, some negative possible | Lot 1: 54 positive, 6 negativeLot 2: 56 positive, 4 negativeLot 3: 58 positive, 2 negative | Lot 1: 56 positive, 4 negativeLot 2: 56 positive, 4 negativeLot 3: 58 positive, 2 negative | |
| For +50% Cutoff (30 ng/mL): 100% Positive calls or very close | Lot 1: 60 positive, 0 negativeLot 2: 60 positive, 0 negativeLot 3: 60 positive, 0 negative | Lot 1: 60 positive, 0 negativeLot 2: 60 positive, 0 negativeLot 3: 60 positive, 0 negative | |
| For +75% Cutoff (35 ng/mL): 100% Positive calls or very close | Lot 1: 60 positive, 0 negativeLot 2: 60 positive, 0 negativeLot 3: 60 positive, 0 negative | Lot 1: 60 positive, 0 negativeLot 2: 60 positive, 0 negativeLot 3: 60 positive, 0 negative | |
| For +100% Cutoff (40 ng/mL): 100% Positive calls or very close | Lot 1: 60 positive, 0 negativeLot 2: 60 positive, 0 negativeLot 3: 60 positive, 0 negative | Lot 1: 60 positive, 0 negativeLot 2: 60 positive, 0 negativeLot 3: 60 positive, 0 negative | |
| Accuracy Study | Overall Agreement: High agreement with LC/MS, especially for samples far from cutoff | Site 1,2,3 (Agreement with LC/MS categories):- Neg. (drug free): 27 Negative- Neg. (<-50% cutoff): 5 Negative- Near cutoff neg (-50% to cutoff): 7 Negative, 1 Positive (discordant)- Near cutoff pos (cutoff to +50% cutoff): 1 Negative (discordant), 8 Positive- Pos. (>+50% cutoff): 31 Positive | Site 1,2,3 (Agreement with LC/MS categories):- Neg. (drug free): 27 Negative- Neg. (<-50% cutoff): 5 Negative- Near cutoff neg (-50% to cutoff): 7 Negative, 1 Positive (discordant)- Near cutoff pos (cutoff to +50% cutoff): 1 Negative (discordant), 8 Positive- Pos. (>+50% cutoff): 31 Positive |
| Home Use Consumer Study | Agreement at 0 ng/mL: 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
| Agreement at -50% Cutoff (10 ng/mL): 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) | |
| Agreement at -25% Cutoff (15 ng/mL): High percentage of Negative (e.g.,>90%) | 93% Agreement (2 Positive, 28 Negative) | 90% Agreement (3 Positive, 27 Negative) | |
| Agreement at +25% Cutoff (25 ng/mL): High percentage of Positive (e.g.,>90%) | 90% Agreement (27 Positive, 3 Negative) | 93% Agreement (28 Positive, 2 Negative) | |
| Agreement at +50% Cutoff (30 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) | |
| Agreement at +100% Cutoff (40 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |
Inferred Performance Acceptance Criteria & Reported Device Performance for Cut-off 50 ng/mL:
| Performance Metric | Implied Acceptance Criteria (Inferred from data presentation) | Rapid Marijuana (THC) Test Strip 50 Reported Performance (Positive/Negative counts at specified concentrations across 3 lots) | Rapid Marijuana (THC) Test Dipcard 50 Reported Performance (Positive/Negative counts at specified concentrations across 3 lots) |
|---|---|---|---|
| Precision Study | For -75% Cutoff (12.5 ng/mL): 100% Negative calls or very close | Lots 1,2,3: 0 positive, 60 negative | Lots 1,2,3: 0 positive, 60 negative |
| For -50% Cutoff (25 ng/mL): 100% Negative calls or very close | Lots 1,2,3: 0 positive, 60 negative | Lots 1,2,3: 0 positive, 60 negative | |
| For -25% Cutoff (37.5 ng/mL): Predominantly Negative calls, some positive possible | Lot 1: 4 positive, 56 negativeLot 2: 6 positive, 54 negativeLot 3: 2 positive, 58 negative | Lot 1: 6 positive, 54 negativeLot 2: 2 positive, 58 negativeLot 3: 6 positive, 54 negative | |
| For Cutoff (50 ng/mL): Mix of Positive and Negative calls (around 50% for each) | Lot 1: 36 positive, 24 negativeLot 2: 38 positive, 22 negativeLot 3: 34 positive, 26 negative | Lot 1: 38 positive, 22 negativeLot 2: 34 positive, 26 negativeLot 3: 36 positive, 24 negative | |
| For +25% Cutoff (62.5 ng/mL): Predominantly Positive calls, some negative possible | Lot 1: 56 positive, 4 negativeLot 2: 56 positive, 4 negativeLot 3: 58 positive, 2 negative | Lot 1: 58 positive, 2 negativeLot 2: 56 positive, 4 negativeLot 3: 54 positive, 6 negative | |
| For +50% Cutoff (75 ng/mL): 100% Positive calls or very close | Lots 1,2,3: 60 positive, 0 negative | Lots 1,2,3: 60 positive, 0 negative | |
| For +75% Cutoff (87.5 ng/mL): 100% Positive calls or very close | Lots 1,2,3: 60 positive, 0 negative | Lots 1,2,3: 60 positive, 0 negative | |
| For +100% Cutoff (100 ng/mL): 100% Positive calls or very close | Lots 1,2,3: 60 positive, 0 negative | Lots 1,2,3: 60 positive, 0 negative | |
| Accuracy Study | Overall Agreement: High agreement with LC/MS, especially for samples far from cutoff | Site 1,2,3 (Agreement with LC/MS categories):- Neg. (drug free): 21 Negative- Neg. (<-50% cutoff): 10 Negative- Near cutoff neg (-50% to cutoff): 8 Negative, 1 Positive (discordant)- Near cutoff pos (cutoff to +50% cutoff): 1 Negative (discordant), 9 Positive- Pos. (>+50% cutoff): 30 Positive | Site 1,2,3 (Agreement with LC/MS categories):- Neg. (drug free): 21 Negative- Neg. (<-50% cutoff): 10 Negative- Near cutoff neg (-50% to cutoff): 8 Negative, 1 Positive (discordant)- Near cutoff pos (cutoff to +50% cutoff): 1 Negative (discordant), 9 Positive- Pos. (>+50% cutoff): 30 Positive |
| Home Use Consumer Study | Agreement at 0 ng/mL: 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) |
| Agreement at -50% Cutoff (25 ng/mL): 100% Negative | 100% Agreement (30 Negative) | 100% Agreement (30 Negative) | |
| Agreement at -25% Cutoff (37.5 ng/mL): High percentage of Negative (e.g.,>90%) | 97% Agreement (1 Positive, 29 Negative) | 93% Agreement (2 Positive, 28 Negative) | |
| Agreement at +25% Cutoff (62.5 ng/mL): High percentage of Positive (e.g.,>90%) | 93% Agreement (28 Positive, 2 Negative) | 93% Agreement (28 Positive, 2 Negative) | |
| Agreement at +50% Cutoff (75 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) | |
| Agreement at +100% Cutoff (100 ng/mL): 100% Positive | 100% Agreement (30 Positive) | 100% Agreement (30 Positive) |
2. Sample Size Used for the Test Set and the Data Provenance
- Precision Study:
- Sample Size: For each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50), 3 lots were tested. Each lot involved 60 determinations for each of 9 concentration levels, across 6 operators at 3 Point-of-Care sites over 10 non-consecutive days. This totals to 1620 observations per device type in the precision study.
- Data Provenance: The document does not explicitly state the country of origin for the urine samples. The study involved spiking drug-free urine specimens. The study itself was conducted at 3 Point-of-Care sites, but their locations are not specified. It is a prospective study as samples were prepared and tested specifically for this evaluation.
- Accuracy Study:
- Sample Size: 80 clinical urine specimens were used for each device type (Strip 20, Dipcard 20, Strip 50, Dipcard 50) and each operator site. Since there were 3 operator sites, this amounts to 80 * 3 = 240 tests (device results vs. LC/MS) for each specificity (20 ng/mL and 50 ng/mL).
- Data Provenance: The samples were described as "clinical urine specimens," implying they were collected from human subjects. The country of origin is not specified, and it's unclear if they were retrospective or prospectively collected for the study.
- Home Use Consumer Study:
- Sample Size: 180 lay users participated in the study. Each user performed 1 test on a provided specimen. The samples were prepared for the study. For each device type and concentration category, 30 determinations were made.
- Data Provenance: The document does not specify the country of origin of the lay users or the urine samples used. It is a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Precision Study: The ground truth for the spiked samples was established by the precise concentration of "-)-11-nor-9-Carboxy-Δ⁹-THC" added to drug-free urine, confirmed with LC/MS. No human experts were involved in establishing this ground truth, as it was based on laboratory preparation and analytical confirmation.
- Accuracy Study: The ground truth for the clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry). LC/MS is described as the "preferred confirmatory method." LC/MS is an analytical chemistry technique, not a human expert. Therefore, no human experts directly established the ground truth in this study; it was based on objective analytical measurement.
- Home Use Consumer Study: Similar to the precision study, the ground truth for samples was established by spiking drugs into urine with concentrations confirmed by LC/MS. No human experts were involved in establishing this ground truth.
4. Adjudication Method for the Test Set
- Precision Study: The results were read by operators comparing the test line intensity to the control line. There is no mention of an adjudication process for discrepancies in reading within the precision study; each determination (positive/negative) was recorded independently.
- Accuracy Study: The device results were compared directly to the LC/MS results. Discordant results are noted in tables (e.g., device positive when LC/MS was negative below cutoff, or device negative when LC/MS was positive above cutoff), but no formal adjudication method (like 2+1 reading) is described beyond this direct comparison.
- Home Use Consumer Study: The "Layer user Results" likely represent the interpretation of the test by the lay users themselves. No specific adjudication method is mentioned.
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
There was no MRMC comparative effectiveness study done. The device is a rapid, screening immunoassay test (similar to a pregnancy test) for qualitative detection of THC metabolites in urine, designed for Over-The-Counter use. It is interpreted visually by the user or an operator. There is no AI component in this device, nor is there a comparison of human readers with vs. without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a lateral flow immunochromatographic assay requiring human visual interpretation. It is not an algorithm-only device. The results are read visually.
7. The Type of Ground Truth Used
- Cross-reactivity and Interference Studies: Ground truth was established by precisely preparing samples with known concentrations of various compounds and expected drug-free or drug-spiked urine.
- Precision Study: Ground truth for the concentration levels of (-)-11-nor-9-Carboxy-Δ⁹-THC was confirmed using LC/MS.
- Accuracy Study: Ground truth for clinical urine specimens was established by LC/MS (Gas Chromatography/Mass spectrometry or Liquid chromatography/Mass spectrometry).
- Home Use Consumer Study: Ground truth for the spiked samples was confirmed using LC/MS.
In summary, the primary ground truth method for quantitative confirmation of drug concentrations in samples was LC/MS.
8. The Sample Size for the Training Set
This information is not applicable to this device. As a rapid, screening immunoassay test, it does not involve machine learning or AI models that require a "training set." Its performance is based on the chemical reactions and visual detection inherent in the lateral flow assay.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this device type.
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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).
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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 -SDate: 2024.01.17 17:24:10 -05'00' |
|---|---|
| Joseph Kotarek | |
| Branch Chief | |
| Division of Chemistryand Toxicology Devices | |
| OHT7: Office of In Vitro Diagnostics | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
Enclosure
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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)
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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
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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) |
|---|---|---|
| ------ | -------- | --------------------- |
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| 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 flowimmunochromatographic assay basedon the principle of antigen antibodyimmunochemistry | 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 | LowestConcentration(ng/mL) | %Cross-reactivity |
|---|---|---|
| 11-nor-Δ9-THC-9-COOH | 20 | 100% |
| 11-nor-Δ8-THC-9-COOH | 20 | 100% |
| 11-Nor-Δ9-THC-carboxyglucuronide | 30 | 66.7% |
| 11-Hydroxy-Δ | 20 | 100% |
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| 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 | LowestConcentration(ng/mL) | %Cross-reactivity |
|---|---|---|
| 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| 11-nor-Δ8-THC-9-COOH | 50 | 100% |
| 11-Nor-Δ9-THC-carboxyglucuronide | 75 | 66.7% |
| 11-Hydroxy-Δ9-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.
| Approximateconcentration of sample | % of cutoff | Number ofdeterminations perlot | ResultLot 1 | ResultLot 2 | ResultLot 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}------------------------------------------------
| Approximateconcentration of sample | % of cutoff | Number ofdeterminations 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 |
| 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%cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Rapid Marijuana (THC) Test Strip 50:
| Approximateconcentration of sample | % of cutoff | Number ofdeterminations perlot | 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:
| Approximateconcentration of sample | % of cutoff | Number ofdeterminations 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-InnovationResult | LC/MS Analysis | Total | ||||
|---|---|---|---|---|---|---|---|
| Neg.(drug free) | Neg. (<-50%cutoff) | Near cutoffneg.(-50%cutoffto cutoff) | Near cutoffpos. (cutoffto+50%cutoff) | Pos. (>+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) | TestResult | DrugConcentration(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-InnovationResult | Neg.(drug free) | Neg. (<-50%cutoff) | Near cutoffneg.(-50%cutoffto cutoff) | Near cutoffpos. (cutoffto+50%cutoff) | Pos. (>+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 Dipcard20 | LC/MS Analysis | |||
|---|---|---|---|---|
| Operator | Cutoff(ng/mL) | Test Result | Drug Concentration(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-InnovationResult | Neg.(drug free ) | Neg. (<-50%cutoff) | Near cutoffneg.(-50%cutoffto cutoff) | Near cutoffpos. (cutoffto+50%cutoff) | Pos. (>+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-InnovationResult | LC/MS Analysis | Total | ||||
|---|---|---|---|---|---|---|---|
| Neg.(drug free) | Neg. (<-50%cutoff) | Near cutoffneg.(-50%cutoffto cutoff) | Near cutoffpos. (cutoffto+50%cutoff) | Pos. (>+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 Dipcard50 | LC/MS Analysis | |||
|---|---|---|---|---|
| Operator | Cutoff(ng/mL) | Test Result | DrugConcentration(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:
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminations per lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| 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:
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminations per lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| 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}------------------------------------------------
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminations per lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| 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:
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminations per lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| 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 ---
§ 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).