(95 days)
Wondfo Buprenorphine Urine Test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a cutoff concentration of 10 ng/mL. The test is available in a dip card format and a cup format. For in vitro diagnostic use only. This product is only intended for prescription use and is not intended for point-of-care 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Wondfo Oxycodone Urine Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a cutoff concentration of 100 ng/mL. The test is available in a dip card format and a cup format. For in vitro diagnostic use only. This product is intended for over-the-counter and prescription use.
The test provides only preliminary test results. A more specific alternative chemical 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.
Immunochromatograph assay for Buprenorphine and Oxycodone Urine Test using a lateral flow, one step system for the qualitative detection of Buprenorphine, Oxycodone(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 is a 510(k) premarket notification for in vitro diagnostic devices, specifically urine tests for Buprenorphine and Oxycodone. It describes the devices, their intended use, and compares them to predicate devices to establish substantial equivalence. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.
Instead, it relies on establishing "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as a legally marketed device. The information provided heavily focuses on the features and intended use comparison rather than detailed performance study results against predefined acceptance criteria.
Therefore, many of the requested items cannot be extracted from this document, as a performance study with acceptance criteria, ground truth, sample sizes for test and training sets, and expert involvement is not described.
Here's what can be extracted based on the document's content:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not provide a table of acceptance criteria (e.g., minimum sensitivity, specificity) for device performance, nor does it report specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The "performance" described is in terms of general characteristics and methodology, establishing similarity to predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not specified.
- Data provenance: Not specified. The document is a regulatory submission for a device manufactured by "Guangzhou Wondfo Biotech Co., Ltd." in China, but it doesn't specify the origin of any testing data. The "test set" in the context of a diagnostic performance study is not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided as a formal performance study with expert-established ground truth for a test set is not detailed in this document.
4. Adjudication method for the test set:
This information is not provided as a formal performance study with a test set and adjudication is not detailed.
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:
- No, an MRMC comparative effectiveness study was not done. These devices are simple, qualitative immunochromatographic assays for drug detection in urine, run by technicians. They are not AI-powered image analysis tools that would involve "human readers" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, in essence, the device is designed for standalone performance in that it provides a visual qualitative result (positive/negative line). Its performance is evaluated by how accurately it detects the target analyte at a given cutoff concentration, which is an "algorithm only" type of assessment for these types of tests. However, specific standalone performance metrics (sensitivity, specificity, accuracy) are not detailed within this summary, nor is the study design for such an evaluation. The document states "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." This implies that the device's "standalone" result is considered preliminary and requires further confirmation by a gold standard.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the "ground truth" for confirming results would be GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS (Liquid Chromatography/Mass Spectrometry), which are highly sensitive and specific analytical chemical methods. This is explicitly stated: "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."
8. The sample size for the training set:
- Not applicable / Not provided. These are immunoassay devices, not AI/ML algorithms that typically involve "training sets" in the conventional sense. Any development or optimization would involve laboratory testing, but a distinct "training set" as understood in machine learning is not relevant here.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As mentioned above, the concept of a "training set" with established ground truth is not relevant for this type of device in the way it's typically understood for AI/ML.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).