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Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test are intended for the qualitative determination of 11-nor-A9-THC-9-COOH and d-propoxyphene (target analyte) at the specific cut-off concentration in human urine. For in vitro diagnostic use only. Wondfo Propoxyphene Urine Test is only intended for prescription use. Wondfo Cannabinoids Urine Test is intended for over-the-counter and prescription use.

Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a cup format. This product is only intended for prescription use.

Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/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.

Immunochromatograph assay for Cannabinoids and Propoxyphene Urine Test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-propoxyphene (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 IqG polyclonal antibody in membrane.

This document describes the Wondfo Cannabinoids Urine Test and the Wondfo Propoxyphene Urine Test, both qualitative immunochromatographic assays for detecting specific drug metabolites in human urine.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" or a "reported device performance" table in the typical sense (e.g., sensitivity, specificity thresholds with corresponding results). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through similar technological characteristics and intended use. The performance is assessed by comparison to the predicate devices.

However, based on the context of drug screening devices and the comparison tables, we can deduce the key performance characteristics that are considered equivalent.

Note: The FDA's substantial equivalence determination implies that the performance of the Wondfo devices is comparable to that of the predicate devices for their stated indications. Specific quantitative performance data (e.g., precision, accuracy percentages) is not included in this summary but would typically be part of a full 510(k) submission.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the performance study reports submitted as part of the 510(k), but it is not summarized here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For drug testing devices, ground truth is typically established using a reference method like Gas Chromatography-Mass Spectrometry (GC/MS).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This would typically be relevant for studies involving human interpretation or subjective assessments, which isn't directly applicable to the core function of these immunoassay devices. If a study involved comparing the device's output to a confirmatory method, the "adjudication" would be based on the result of the confirmatory method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to these devices. These are standalone diagnostic test devices (immunoassays) that produce a qualitative result (positive/negative) based on a chemical reaction, not on human interpretation of complex images or data where "human readers improve with AI vs. without AI assistance" would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies supporting these devices are inherently standalone performance studies. The devices themselves are designed to operate without human intervention in result generation; the reading of the test strip/cup is a direct visual interpretation of the chemical reaction. The comparison to predicate devices, and underlying performance studies (though not detailed here), would be based on the device's ability to accurately detect the target analytes.

7. Type of Ground Truth Used

Based on common practices for drug testing devices, the type of ground truth used would almost certainly be a confirmatory analytical method, specifically Gas Chromatography-Mass Spectrometry (GC/MS). Both indications for use statements explicitly mention GC/MS as the preferred confirmatory method for obtaining a confirmed analytical result.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. These devices are immunoassays that rely on established chemical principles; they typically do not involve machine learning algorithms that require "training sets" in the same way modern AI/ML devices do. Performance data would be collected from clinical samples to validate the device.

9. How the Ground Truth for the Training Set was Established

As these devices do not utilize a "training set" in the context of machine learning, this question is not applicable. The underlying validation of the immunoassay chemistry would be established through analytical studies using controlled samples with known concentrations of the target analytes, and then validated with clinical samples where truth is established by a confirmatory method like GC/MS.

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