(28 days)
Not Found
No
The device is a simple lateral flow immunochromatographic assay for qualitative detection, which does not involve complex data processing or algorithmic decision-making characteristic of AI/ML. The summary explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
This device is an in vitro diagnostic (IVD) test used for the qualitative detection of marijuana in human urine, providing preliminary test results rather than treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For in vitro diagnostic use only."
No
The device description explicitly states the product is a "single-use in vitro diagnostic device" and includes a "Test Device" which is a physical component (dip card or strip) for performing the assay. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only."
- Device Description: The "Device Description" section describes the products as "single-use in vitro diagnostic devices."
- Nature of the Test: The test is designed to detect a substance (Marijuana) in a human biological sample (urine) to provide information about a physiological state (presence of Marijuana). This is the core function of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Product codes
NFW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Precision Study:
- Sample Size: For each concentration, tests were performed two runs per day for 25 days per device (total 50 tests per concentration). There were multiple concentrations tested.
- Data Source: 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-Δ9-THC-9-COOH in negative samples.
- Annotation Protocol: Each 11-Nor-Δ9-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.
Method Comparison Studies (In-house):
- Sample Size: 80 (40 negative and 40 positive) unaltered clinical samples for each device format.
- Data Source: Unaltered clinical samples.
- Annotation Protocol: The samples were blind labeled and compared to LC/MS results. Three laboratory assistants performed the tests.
Lay-user study:
- Sample Size: 280 lay persons at three intended user sites.
- Data Source: Urine samples were prepared at the following concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens.
- Annotation Protocol: The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
a. Precision:
- Study Type: Precision study.
- Sample Size: 50 tests per concentration for each lot (total 3 lots).
- Key Results:
- Dip Card: At cut off (25-/25+, 23-/27+, 24-/26+ for Lot 1, 2, 3 respectively). For -100% to -25% cut off, all 50 samples were negative. For +25% to +100% cut off, all 50 samples were positive.
- Strip: At cut off (19-/31+, 28-/22+, 23-/27+ for Lot 1, 2, 3 respectively). For -100% to -25% cut off, all 50 samples were negative. For +25% to +100% cut off, all 50 samples were positive.
c. Stability:
- Study Type: Stability study (accelerated and real-time).
- Key Results: 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:
- Study Type: Interference study.
- Key Results: Compounds that showed no interference at a concentration of 100ug/mL (albumin at 100 mg/dL and ethanol at 1%) were identified. No differences were observed for both the strip and dip card formats.
e. Specificity:
- Study Type: Specificity study.
- Key Results: Cross-reactivity was tested for various THC compounds and other cannabinoids. For example, 11-nor-Δ9-THC-9-COOH, 11-Hydroxy-Δ9-Tetrahydrocannabinol, 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH, and (-)-11-nor-9-carboxy-Δ 9-THC showed 100% cross-reactivity at 50 ng/mL. Other compounds like Cannabinol and Δ9-Tetrahydrocannabinol showed lower cross-reactivity at much higher concentrations. No differences for different device formats.
f. Effect of Urine Specific Gravity and Urine pH:
- Study Type: Effect of urine specific gravity and urine pH study.
- Key Results: All results were positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, when spiked with target drugs in urine samples with 1.000 to 1.035 specific gravity or pH 4 to 9. No differences were observed for different device formats.
2. Comparison Studies
Method comparison studies:
- Study Type: In-house laboratory comparison with LC/MS.
- Sample Size: 80 clinical samples (40 negative, 40 positive) for each format.
- Key Results:
- Strip Format:
- Viewer A: 0 positive for negative, 0 positive for low negative, 1 positive for near cutoff negative, 21 positive for near cutoff positive, 18 positive for high positive.
- Viewer B: 0 positive for negative, 0 positive for low negative, 1 positive for near cutoff negative, 20 positive for near cutoff positive, 18 positive for high positive.
- Viewer C: 0 positive for negative, 0 positive for low negative, 2 positive for near cutoff negative, 21 positive for near cutoff positive, 18 positive for high positive.
- Discordant Results: THCC368 (48.8, positive by BIOEASY), THCC363 (46.95, positive by BIOEASY), THCC493 (50.5, negative by BIOEASY), THCC478 (55.5, negative by BIOEASY).
- Dip Card Format:
- Viewer D: 0 positive for negative, 0 positive for low negative, 2 positive for near cutoff negative, 20 positive for near cutoff positive, 18 positive for high positive.
- Viewer E: 0 positive for negative, 0 positive for low negative, 1 positive for near cutoff negative, 20 positive for near cutoff positive, 18 positive for high positive.
- Viewer F: 0 positive for negative, 0 positive for low negative, 2 positive for near cutoff negative, 20 positive for near cutoff positive, 18 positive for high positive.
- Discordant Results: THCC368 (48.8, positive by BIOEASY), THCC402 (46, positive by BIOEASY), THCC363 (46.95, positive by BIOEASY), THCC478 (55.5, negative by BIOEASY), THCC493 (50.5, negative by BIOEASY), THCC318 (56, negative by BIOEASY).
- Strip Format:
Lay-user study:
- Study Type: Usability study.
- Sample Size: 280 lay persons.
- Key Results:
- Strip Format:
- -100%, -75%, -50% Cutoff: 100% correct results (20/20 negative).
- -25% Cutoff: 95% correct results (19 negative, 1 positive).
- +25% Cutoff: 90% correct results (18 positive, 2 negative).
- +50%, +75% Cutoff: 100% correct results (20/20 positive).
- Dip Card Format:
- -100%, -75%, -50% Cutoff: 100% correct results (20/20 negative).
- -25% Cutoff: 90% correct results (18 negative, 2 positive).
- +25% Cutoff: 90% correct results (18 positive, 2 negative).
- +50%, +75% Cutoff: 100% correct results (20/20 positive).
- All lay users indicated that the device instructions can be easily followed. The package insert score revealed a reading Grade Level of 7.
- Strip Format:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as Sensitivity, Specificity, PPV, NPV, but inferred from performance tables.
Precision (Agreement to expected result):
- Dip Card:
- At cut-off (50 ng/mL): 25/25, 23/27, 24/26 for negative/positive results out of 50 samples for Lot 1, 2, 3 respectively.
- At -25% cut-off (37.5 ng/mL): 100% negative (50/50) for all lots.
- At +25% cut-off (62.5 ng/mL): 100% positive (50/50) for all lots.
- Strip:
- At cut-off (50 ng/mL): 19/31, 28/22, 23/27 for negative/positive results out of 50 samples for Lot 1, 2, 3 respectively.
- At -25% cut-off (37.5 ng/mL): 100% negative (50/50) for all lots.
- At +25% cut-off (62.5 ng/mL): 100% positive (50/50) for all lots.
Lay User Study - Percentage of correct results:
- Strip Format:
- 100% for -100%, -75%, -50% Cutoff.
- 95% for -25% Cutoff.
- 90% for +25% Cutoff.
- 100% for +50%, +75% Cutoff.
- Dip Card Format:
- 100% for -100%, -75%, -50% Cutoff.
- 90% for -25% Cutoff.
- 90% for +25% Cutoff.
- 100% for +50%, +75% Cutoff.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2019
Shenzhen Bioeasy Biotechnology Co., Ltd. % Joe Shia, Director LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K192301
Trade/Device Name: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: NFW Dated: August 18, 2019 Received: August 23, 2019
Dear Joe Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192301
Device Name BIOEASY Marijuana Test Dip Card BIOEASY Marijuana Test Strip
Indications for Use (Describe)
BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K192301 510(k) SUMMARY
-
- Date: September 4, 2019 2. Submitter: Shenzhen Bioeasy Biotechnology Co., Ltd. No.2-1, Liuxian 1st Road Baoan District Shenzhen, China 518101 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
-
- Device Name: BIOEASY Marijuana Test Dip Card BIOEASY Marijuana Test Strip
Classification: Class 2
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NFW | |||
| Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids | |
| Test System | Toxicology (91) |
-
- Predicate Devices: K182530
The Bioeasy Multi-Drug Test Cup
- Predicate Devices: K182530
-
- Indications for Use
BIOEASY Marijuana Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
- Indications for Use
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
BIOEASY Marijuana Test Strip is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Marijuana in human urine at the cutoff concentrations of 50 ng/mL.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
-
- Device 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
- Device Description
4
aluminum pouch
-
- Substantial Equivalence Information
A summary comparison of features of the BIOEASY Marijuana tests and the predicate devices is provided in following table.
- Substantial Equivalence Information
| 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 | 11-Nor-Δ9-THC-9-COOH | |
| 50 ng/ml | Same | |
| 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 over-the-counter | Same |
| Configurations | Dip Card and Strip | Cup |
Table 1: Features Comparison of BIOEASY Marijuana Test Dip Card and BIOEASY Mariiuana Test Strip tests and the Predicate Devices
9. Test Principle
The BIOEASY Marijuana Test Dip Card and the BIOEASY Marijuana Test Strip tests are rapid tests for the qualitative detection of Marijuana in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If the target drug present in the urine specimen is below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
10. Performance Characteristics
-
- 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
5
samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables.
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card
Strip
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 ℃ and real time stability determinations at both 4 ℃ and 30 ℃.
d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL and ethanol was tested at 1%) are summarized in the following tables. There were no differences observed for both the strip and dip card formats.
| Acetaminophen | ß-Estradiol | Oxalic acid |
|---|---|---|
| Acetophenetidin | Erythromycin | Oxolinic acid |
| N-Acetylprocainamide | Ethanol (1% v/v) | Oxymetazoline |
| Acetylsalicylic acid | Fenoprofen | Papaverine |
| Albumin (100 mg/dL) | Furosemide | Penicillin G |
| Aminopyrine | Gentisic acid | Perphenazine |
| Amoxicillin | Hemoglobin | Phenelzine |
| Ampicillin | Hydralazine | Prednisone |
| Apomorphine | Hydrochlorothiazide | (±)-Propranolol |
| Ascorbic acid | Hydrocortisone | Pseudoephedrine |
| Aspartame | O-Hydroxyhippuric acid | Quinine |
| Atropine | 3-Hydroxytyramine | Ranitidine |
| Benzilic acid | Ibuprofen | Salicylic acid |
| Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Chloral hydrate | Ketamine | Sulindac |
| Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate |
| Chlorpromazine | Loperamide | Tetrahydrozoline |
6
| Cholesterol | Meperidine | Thiamine |
|---|---|---|
| Clonidine | Meprobamate | Thioridazine |
| Cortisone | Methoxyphenamine | Triamterene |
| (-)-Cotinine | Nalidixic acid | Trifluoperazine |
| Creatinine | Naloxone | Trimethoprim |
| Deoxycorticosterone | Naltrexone | DL-Tryptophan |
| Dextromethorphan | Naproxen | Tyramine |
| Diclofenac | Niacinamide | DL-Tyrosine |
| Diflunisal | Nifedipine | Uric acid |
| Digoxin | Norethindrone | Verapamil |
| Diphenhydramine | Noscapine | Zomepirac |
| Ecgonine methyl ester | (±)-Octopamine |
e. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device format. The lowest concentration that caused a positive result for each compound are listed below. There are no differences for different device formats.
| THC(Cannabinoids)
| (11-nor-Δ9-THC-9-COOH, Cut-off = 50 ng/mL) | Result | % Cross-Reactivity |
|---|---|---|
| 11-nor-Δ9-THC-9-COOH | Positive at 50 ng/mL | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | Positive at 50 ng/mL | 100% |
| 11-Nor-Δ8-Tetrahydrocannabinol-9-COOH | Positive at 50 ng/mL | 100% |
| Cannabinol | Positive at 20000 ng/mL | 0.25% |
| Δ8-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33% |
| Δ9-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33% |
| Cannabidiol | Positive > 100000 ng/mL | 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking 11-Nor-△9-THC-9-COOH into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Summary results are shown below. |
The results summary for strip format:
| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of
Positive | No. of
Negative | correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25.3 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 40.1 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 65 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 79 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 93 | 20 | 0 | 100 |
The results summary for dip card format:
| % of Cutoff | Number of samples | Drug Concentration by LC/MS/MS(ng/mL) | Lay person Results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 25.3 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 40.1 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 65 | 18 | 2 | 90 |
| +50% Cutoff | 20 | 79 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 93 | 20 | 0 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
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- Clinical Studies
Not applicable.
- Clinical Studies
-
- Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the device, it's concluded that
- Conclusion
9
the BIOEASY Marijuana Test Dip Card and BIOEASY Marijuana Test Strip tests are substantially equivalent to the predicate.