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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. It is intended for over the counter use.

The Buprenorphine assay will yield preliminary positive results when Buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The Wondfo Buprenorphine Urine Test shows the drug was or was not present at the cutoff level. 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 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.

The device does not differentiate between drug abuse and prescription use of buprenorphine.

Immunochromatograph assays for Buprenorphine Urine Tests use a lateral flow, one step system for the qualitative detection of Buprenorphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

Here's a breakdown of the acceptance criteria and study information for the Wondfo Buprenorphine Urine Test, based on the provided text:

Acceptance Criteria and Device Performance

The provided text only explicitly states the performance for the lay-user study as percentages of agreement with GC/MS. This can be interpreted as the acceptance criteria for user comprehension and accurate result interpretation by lay users.

Note: The acceptance criteria are inferred based on the observed high agreement for most concentrations. The 90.0% and 95.0% performance at +/-25% cutoff suggests a tolerance for slight variations near the cutoff, which is common in qualitative assays.

Study Information

2. Sample Size and Data Provenance:

• Test Set Sample Size (Lay-user study):
  • Cup format: 140 lay persons were involved. The urine samples were prepared at 7 different concentrations, with 20 samples per concentration. So, a total of 140 urine samples were tested.
  • Dip Card format: 140 lay persons were involved. The urine samples were prepared at 7 different concentrations, with 20 samples per concentration. So, a total of 140 urine samples were tested.
• Data Provenance: The study was performed at "three intended user sites." The country of origin is not explicitly stated, but the manufacturer is "Guangzhou Wondfo Biotech Co., Ltd." in Guangzhou, P.R. China. The study appears to be a prospective user study, as participants were provided with blind-labeled samples and devices for testing.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not applicable. The ground truth for the test set was established by objective chemical analysis (GC/MS), not by expert interpretation of the device results.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The ground truth was established by GC/MS, which is a definitive chemical method and does not require adjudication of human interpretations. The lay users performed the test and recorded the results, which were then compared to the GC/MS confirmed concentrations.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement of lay users with the device results compared to a gold standard (GC/MS), not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study:

• Standalone Study Done: Yes, in essence, the "Lay-user study" is a standalone performance study in the context of Over-the-Counter (OTC) use. It evaluates the device's ability to provide accurate results when used by its intended end-users (lay persons) without professional intervention. The device's output (positive/negative) is directly compared to the true concentration.
  • The document also references "Analytical Performance" and "Comparison Studies" in predicate K113624, implying that a more technical standalone analytical performance (measuring sensitivity, specificity, accuracy against known concentrations) would have been performed and documented in the predicate device’s submission.

7. Type of Ground Truth Used:

• Ground Truth Type: Objective chemical analysis, specifically GC/MS. The concentrations of urine samples were "confirmed by GC/MS."

8. Sample Size for the Training Set:

• Training Set Sample Size: The document does not provide information about a "training set" or explicit details of the algorithm's development. This is a point-of-care immunoassay, not an AI device in the modern sense. Therefore, the concept of a training set for an algorithm is not directly applicable here. The device's performance relies on its physical and chemical properties developed through traditional R&D, not machine learning.

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

• Ground Truth Establishment for Training Set: Not applicable, as there isn't a "training set" in the context of an algorithm. The development of such immunoassay devices typically involves extensive analytical testing of various concentrations and interfering substances to optimize the performance characteristics (e.g., antibody specificity, cutoff concentration calibration), which would form the "ground truth" for its design and manufacturing.

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The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in human urine at a designated cutoff concentration of 10 ng/mL. They are intended for use by healthcare professionals including professionals at point-of-care sites to assist in the determination of drug compliance.

This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result atchuid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory mcthods.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The ACON BUP One Step Buprenorphine Test Strip and the ACON BUP One Step Buprenorphine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Buprenorphine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Buprenorphine in urine at a cutoff concentration of 10 ng/mL. These tests can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Buprenorphine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text describes the ACON BUP One Step Buprenorphine Test Strip and Device, which are rapid chromatographic immunoassays for the qualitative detection of Buprenorphine in urine.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific percentages for positive, negative, or overall agreement. Instead, it presents the device's performance results against two comparators: a FDA-cleared Buprenorphine test and LC/MS analysis. The "acceptance" is implied by the FDA's substantial equivalence determination, meaning the performance was deemed acceptable relative to a legally marketed predicate.

However, we can infer performance targets for the purpose of demonstrating substantial equivalence. The reported performance is as follows:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for the Test Set: 226 clinical urine specimens.
• Data Provenance: The document does not specify the country of origin. The study used "clinical urine specimens," implying they were collected from real-world patients, but it doesn't state if they were collected retrospectively or prospectively. Given the context of a 510(k) submission and the term "clinical evaluation," it's likely a retrospective collection of samples with known Buprenorphine concentrations or confirmed by an existing method.

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)

The document does not mention the use of experts to establish ground truth for the test set. The ground truth was established by:

• Comparison with an FDA-cleared Buprenorphine test.
• Comparison with Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which is considered the "gold standard" for drug confirmation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method involving human readers is described for the test set. The comparisons are entirely based on the results from the devices, the predicate device, and LC/MS.

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 MRMC comparative effectiveness study was done. This device is a standalone immunoassay kit, not an AI-powered diagnostic system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was conducted. The ACON BUP One Step Buprenorphine Test Strip and Test Device are intended to be used as standalone tests, providing a qualitative result. The "Safety and Effectiveness Data" section details the performance of these devices in comparison to existing methods without any human-in-the-loop assistance for interpretation beyond reading the visual result of the strip/device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance evaluation was established using:

• Comparison against an FDA-cleared predicate Buprenorphine test.
• Liquid Chromatography/Mass Spectrometry (LC/MS) analysis, which is a highly specific and sensitive analytical method considered definitive for drug identification and quantification.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI. This device is an immunoassay, not an algorithm that requires training data. The development and validation of the immunoassay itself would have involved laboratory testing and optimization, but not a "training set" in the computational sense.

9. How the ground truth for the training set was established

As there is no mention of a training set for an algorithm, this question is not applicable to the described device.

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