(601 days)
A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over the counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids.
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 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.
Not Found
The provided text is a 510(k) FDA clearance letter for the "Wunder Test™" which is a Cannabinoid Test System. It does not contain a detailed study report with all the specific information requested in the prompt. Much of the information requested, such as sample sizes for training/test sets, ground truth establishment, and expert qualifications, is typically found in the submission's technical documentation, not the clearance letter itself.
However, based on the limited information available in this FDA clearance letter document, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The provided document (FDAClearanceLetter_WunderTest.pdf) does not contain a table of acceptance criteria and reported device performance. It only states the device's intended use and cutoff.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
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)
This information is not available in the provided document. The ground truth for drug tests like this generally involves confirmatory methods, but the specifics of how that was established for the test set are not detailed here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
This is an immunoassay and not an AI-based image analysis device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as "visually read" and "intended for over the counter single use." This indicates that it is a standalone test performed by an individual, not an algorithm requiring human intervention after an automated analysis. The performance would be the direct result of the visual interpretation of the test based on the chemical reaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method." This strongly suggests that Gas Chromatography-Mass Spectrometry (GC/MS) was used as the ground truth for confirming cannabinoid presence and concentration in the study.
8. The sample size for the training set
This information is not available in the provided document. For an immunoassay, the "training set" would typically refer to samples used during the development and optimization of the assay's chemical components and read-out parameters, rather than a machine learning training set.
9. How the ground truth for the training set was established
This information is not available in the provided document. Similar to the test set, it would likely involve GC/MS or a comparable highly accurate reference method.
Summary of what is available / could be inferred:
- Device Name: Wunder Test™
- Indication for Use: Qualitative determination of Cannabinoids in human urine, visually read, intended for over-the-counter single use.
- Cutoff: 50 ng/mL of Cannabinoids.
- Ground Truth Method for Confirmation: GC/MS (preferred confirmatory method).
- Type of Study: Implied to be a standalone performance study.
- AI Involvement: None, as this is a visually read immunoassay.
Conclusion:
The provided FDA clearance letter offers limited details regarding the specifics of the underlying study's methodology, particularly regarding sample sizes, expert involvement, and detailed acceptance criteria or performance metrics. This information would typically be found in the 510(k) submission itself, which is a much larger and more detailed technical document. The letter serves as an official communication of the FDA's decision based on its review of that submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Hien Helen Nguyen 1810 Oakland Rd Ste E San Jose, CA 95131
Re:
APR 1 8 2012
K102428 Trade Name: Wunder Test™ Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ Dated: April 12, 2012 Received: April 17, 2012
Dear Ms. Nguyen:
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 Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
N
Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
. Enclosure
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Indications for Use
510(k) Number (if known): K102428
Device Name: Wunder Test
Indications For Use:
A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over the counter single use. The test has a cutoff of 50 ng/mL of Cannabinoids.
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 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use x (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k). K102428
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§ 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).