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510(k) Data Aggregation
(279 days)
The Visualine® Methadone DipStrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.
The Visualine® Methadone DipStripTest is based on the principle of antigen-antibody complexation and is used for the analysis of Methadone and it's metabolites in urine samples. The assay utilizes a competitive immunochromatographic technique involving a sample of test urine delivered in a sample well on the device that holds the porous membrane. When the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the colored microspheres. When an adequate amount of drug is present, it will fill the limited antibody binding sites. This will prevent attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of precipitin at the probe site. A reference or control line with a secondary antibody reaction is added to the membrane strip to indicate viability of the test. This control line should always be present. A negative urine sample will produce two colored lines and a positive urine sample will show only one, the control line.
The Visualine® Methadone DipStripTest is an in-vitro immunoassay test by visual color comparison for the detection of Methadone and its metabolites in human urine samples, intended for professional use only.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytical Sensitivity: | |
| - 0 ng/ml Methadone: Two distinct visible magenta lines (test and control) | Achieved (stated for stability: "A urine specimen containing 0 ng/ml of the analyte of interest will always render two distinct visible magenta lines, one test line and one control line.") |
| - 360 ng/ml Methadone: Positive results (>99% yielding only control line) | Achieved ("Samples containing 360 ng/ml of methadone show positive results >99% of the time, (yielding only the control line).") |
| Correlation with Hitachi EmitII® Methadone Assay (cutoff 300 ng/ml): | |
| - Analytical Sensitivity: >= 99% Agreement | >99% Agreement (56/56) |
| - Analytical Specificity: >= 99% Agreement | >99% Agreement (76/76) |
| - Analytical Efficiency: >= 99% Agreement | >99% Agreement (132/132) |
| Precision: | |
| - Within run and run to run: >99% | >99% |
| - Within day and day to day: >99% | >99% |
| - Within lot and lot to lot: >99% | >99% |
| Stability: | |
| - Stable within marked expiration date and under specified storage conditions | Tested every three months and reviewed for acceptance by QC Manager for up to a period of over two years, meeting acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For Correlation Studies: 132 urine samples (56 positive, 76 negative based on Hitachi EmitII® Methadone Assay).
- For Analytical Sensitivity (360 ng/ml Methadone): The exact number of samples tested at 360 ng/ml isn't explicitly stated as a distinct sample size for that specific concentration, but the >99% performance suggests a sufficient number were used. It's likely a subset or part of a larger panel of samples tested to establish sensitivity.
- Data Provenance: The samples were "provided by The Lab, Inc." and the correlation studies were "conducted at Sun Biomedical Laboratories". The origin of the samples (e.g., country, specific types of patients) is not specified. It is a retrospective analysis as it used existing samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was not established by human experts in a traditional sense. Instead, the Hitachi EmitII® Methadone Assay with a cutoff at or above 300 ng/ml Methadone was used as the reference method (the "gold standard" or ground truth comparator). Therefore, no human experts with specific qualifications were involved in establishing the ground truth for these correlation studies.
4. Adjudication Method for the Test Set
Since the Hitachi EmitII® Methadone Assay served as the reference method, there was no human adjudication process involved for the test results of the Visualine® Methadone DipStrip Test. The results of the DipStrip Test were simply compared directly against the results of the Hitachi assay.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or performed as part of this submission. The study focuses purely on the standalone performance of the Visualine® Methadone DipStrip Test against a predicate device. This is a comparison of two analytical test systems, not a reader-based study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance studies of the Visualine® Methadone DipStrip Test. The performance characteristics (sensitivity, specificity, efficiency, precision, stability) are intrinsic to the device itself when interpreted visually. While human interpretation of the visual color lines is part of the test's operation, the "standalone" context here refers to evaluating the device's accuracy compared to a reference method, rather than evaluating human readers using the device and comparing them to human readers without the device.
7. The Type of Ground Truth Used
The primary ground truth used was the results from the Hitachi EmitII® Methadone Assay, which is a homogenous enzyme immunoassay. This served as the reference method for determining the true positive or true negative status of the urine samples for methadone.
8. The Sample Size for the Training Set
The document does not explicitly mention a distinct "training set" or its sample size. Immunoassay devices typically do not undergo a training phase in the same way machine learning algorithms do. Development of such devices involves extensive R&D and optimization (which could be considered analogous to "training"), but specific sample sizes for this internal development are not usually disclosed in 510(k) summaries, nor is there a formal "training set" in the context of clinical validation as with AI models. The samples mentioned (132 for correlation) are for performance validation.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is described in the provided document, the method for establishing its ground truth is also not applicable or not specified. The focus of the 510(k) summary is on demonstrating performance against predicate devices using a validation set.
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