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Wondfo Multi-Drug Urine Test Cup and Woridfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of:

Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCIMS 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 Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine samples. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.

The provided document is a 510(k) premarket notification for the "Wondfo Multi-Drug Urine Test Cup" and "Wondfo Multi-Drug Urine Test Panel." This type of document focuses on establishing substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance metrics in the same way a de novo or PMA application might.

Therefore, the document does not contain explicit acceptance criteria and a study proving the device meets them in the format requested. It describes the device, its intended use, and classifies it based on existing regulations. It also mentions that the device is a "modified" product derived from previously FDA-cleared single DOA tests.

However, based on the information provided, we can infer some aspects and highlight what is missing:

Inferred Information based on provided text:

While explicit acceptance criteria are not stated, the document implies that the device's performance is gauged by its ability to qualitatively detect specific drugs at defined cut-off levels in human urine. The "comparison to the predicate device" section suggests that the device's design and likely its performance characteristics are substantially equivalent to previously cleared single-drug tests.

Missing Information (not present in the provided text):

The detailed information requested regarding specific acceptance criteria, study performance data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not explicitly available in this summary.

Summary of missing information based on your request:

1. A table of acceptance criteria and the reported device performance: Not explicitly provided. The cut-off levels are listed but without corresponding performance metrics (e.g., sensitivity, specificity, accuracy) that would demonstrate acceptance.
2. Sample sized used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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: Not applicable/provided. This is a drug screening test, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is a biochemical assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "GC/MS is the preferred confirmatory method," which implies Gas Chromatography/Mass Spectrometry is used as the ground truth for confirming drug presence and concentration.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not explicitly stated, but likely also through GC/MS, consistent with the confirmatory method for test results.

Conclusion:

The provided document is a regulatory submission demonstrating substantial equivalence for a multi-drug urine test, and as such, it focuses on classification, intended use, and comparison to predicate devices, rather than detailed performance data from a specific study against acceptance criteria. The performance data and acceptance criteria would typically be found in accompanying technical sections of the 510(k) submission, which are not included in this summary.

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