(119 days)
Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of Cannabinoids in human urine. The test is available in a cassette format. The test has a cutoff of 50ng/mL of Cannabinoids. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Immunochromatographic assay for Cannabinoids urine test using a lateral flow system for the qualitative detection of Cannabinoids in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.
Here's an analysis of the provided text, extracting information related to acceptance criteria and the supporting study:
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided text does not explicitly state specific acceptance criteria in a quantitative manner (e.g., "sensitivity must be >95%"). It generally states that the device has "similar technological characteristics and performance to the predicate and are equivalent." Therefore, the table below reflects what can be inferred or is directly mentioned.
| Acceptance Criteria (Inferred/Stated) | Reported Device Performance |
|---|---|
| Qualitative detection of Cannabinoids | Qualitatively detects Cannabinoids in human urine |
| Cutoff concentration | 50 ng/mL of Cannabinoids |
| Performance similar to predicate device (K020771) | Device is deemed "equivalent" to the predicate, implying similar performance characteristics. |
| Intended for prescription and OTC use | Indicated for prescription and over-the-counter use |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not contain any information about the sample size used for the test set or the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The provided text does not contain any information about the number of experts used or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not contain any information about an adjudication method. The device is an immunochromatographic assay, which typically produces a direct "positive" or "negative" result based on chemical reaction, rather than requiring expert adjudication. However, it does state that "A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method," indicating that initial results are preliminary and further, more definitive testing is recommended for confirmation.
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
The provided text does not contain any information about an MRMC study or AI assistance. The device is a diagnostic test kit, not an AI-powered system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's inherent performance. The Wondfo Cannabinoids Urine Test is a standalone device in that it provides a direct qualitative result without a "human-in-the-loop" for interpreting the primary reaction. The "standalone performance" is implicitly established by demonstrating its ability to detect cannabinoids at the specified cutoff.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The text mentions that "A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method." This indicates that Gas Chromatography-Mass Spectrometry (GCMS) is the accepted "ground truth" or gold standard for confirming the presence and concentration of cannabinoids.
8. The sample size for the training set
The provided text does not contain any information about the sample size for a training set. This type of information is usually associated with machine learning or AI-based devices, which this diagnostic test is not.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of this immunochromatographic assay, there is no information provided on how ground truth for a training set was established.
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Premarket Notification - Guangzhou Wond
Co. Ltd. K110182
TABLE 4
Submitter's name: Address:
Phone:
SUMMARY
December 13, 2010
Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069
MAY 2 0 2011
Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6231
Date the summary was prepared:
Name of the device: Trade or proprietary name: Common or usual name:
Cannabinoids Urine Test Cannabinoids Urine Test lmmunochromatographic test for the qualitative detection of Cannabinoids
Classification: Class II medical device with the product codes with Code of Federal Regulation references:
CFR # Product Code 862.3870 LDJ
The legally marketed device to which we are claiming equivalence [807.92((3)]: illy marketed device to which Step Drug Screen Test Card, K020771.
Description of the device:
Assay Principle: Immunochromatographic assay for Cannabinoids urine test using a lateral Assay Principle: Immunochromation of Cannabinoids in human urine. Each assay uses a
flow system for the qualitative detection of Cannabinoids in human note ableside and fixed flow system for the qualitative detection of ourinament thrug with gold chloride and fixed monoclonal antibody-dye congugate from medio against any
drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.
Intended use of the device:
The Cannabinoids Urine Test is intended for the qualitative determination of Cannabinoids in human i he Cannabilioius Unite Test is intended for the qualities and over the counter use.
Summary of the technological characteristics of our device compared to the predicate device:
The Wondfo Biotech Co., Ltd. Cannabinoids have similar technological characteristics and performance to the predicate and are equivalent.
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Image /page/1/Picture/12 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - GSA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with outstretched wings. The eagle's body is formed by three curved lines, giving it a modern and abstract appearance. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY 20 2011
Guangzhou Wondfo Biotech Co., LTD. c/o Joe Shia, LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877
Re: K110182
Trade Name: Wondfo Cannabinoids Urine Test Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ Dated: May 16, 2011 Received: May 19, 2011
Dear Mr. 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: Vijs
Enclosure
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INDICATIONS FOR USE FORM
510(k) Number (if known): K110182
Device Name: Wondfo Cannabinoids Urine Test
Indications for Use:
Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of Cannabinoids in human urine. The test is available in a cassette format. The test has a cutoff of 50ng/mL of Cannabinoids. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ X (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110182
§ 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).