(46 days)
Wondfo Methylenedioxymethamine Urine Test is an immunochromatographic assay for the qualitative determination of MDMA in human urine at a cutoff concentration of 500ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.
Wondfo Morphine Urine Test is an Immunochromatographic assay for the qualitative determination of Morphine in human urine at a cutoff concentration of 300ng/mL. The test is available In a dip card format and a cup format. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed 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.
Immunochromatograph assay for Methylenedioxymethamphetamine and Morphine Urine Test using a lateral flow, one step system for the qualitative detection of MDMA, Morphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
The provided document describes the Wondfo Methylenedioxymethamphetamine Urine Test and Wondfo Morphine Urine Test for the qualitative determination of MDMA and Morphine in human urine. However, the document does not contain specific acceptance criteria or performance study data with numerical results that would allow for a table comparing acceptance criteria to reported device performance. It primarily focuses on the device description, intended use, and substantial equivalence to predicate devices, along with the FDA's clearance letter.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:
1. A table of acceptance criteria and the reported device performance
The provided document does not specify quantitative acceptance criteria for performance such as sensitivity, specificity, or accuracy, nor does it present detailed performance study results against such criteria. It states that the device has "similar technological characteristics and performance to the predicate and are equivalent."
The key performance characteristics mentioned are the cut-off values:
| Analyte | Cut-off Value |
|---|---|
| Methylenedioxymethamphetamine | 500 ng/ml |
| Morphine | 300 ng/ml |
The document does not include a study that provides reported device performance values (e.g., sensitivity, specificity, accuracy) against these cut-off levels or any other defined acceptance criteria.
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 provided in the 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 provided in the document. For drug tests, ground truth is typically established by confirmatory methods like GC/MS, not expert consensus in the same way as imaging analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 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 type of study is not applicable to this device. The Wondfo Urine Tests are qualitative immunoassay devices for drug detection, not AI/imaging analysis tools that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone test kit (lateral flow immunoassay). The document implies its performance was evaluated standalone by stating its "technological characteristics and performance to the predicate and are equivalent," but it does not detail the specific standalone study methodology or results. There is no "algorithm" in the sense of software for interpretation for this type of device; the user directly interprets the lines on the test card.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS is the preferred confirmatory method." Therefore, the ground truth for establishing device performance would have been Gas Chromatography/Mass Spectrometry (GC/MS).
8. The sample size for the training set
This information is not provided in the document. As an immunoassay, the concept of a "training set" in the machine learning sense is not directly applicable. However, if this refers to samples used for initial development or optimization, those details are not present.
9. How the ground truth for the training set was established
This information is not provided for a "training set." If development or optimization samples were used, the ground truth would likely have been established using a confirmatory method like GC/MS, similar to the test set, but specific details are absent.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).