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For Sure One Step Buprenorphine Strip Test Device is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.

The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

The For Sure One Step Buprenorphine Strip Test Device consists of a chromatographic The For Barevice in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled As the test sumple no we the free drug in the specimen forming an antibody-antigen annoote) - ouslex competes with immobilized antigen conjugate in the Test complex. This one and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's a summary of the acceptance criteria and the study details for the For Sure One Step Buprenorphine Strip Test Device, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in terms of sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be implicit in the claim of substantial equivalence to the predicate device and GC/MS. The study aims to demonstrate that the device performs comparably to these methods for qualitative detection of buprenorphine in urine.

The reported device performance is described qualitatively by comparing its characteristics to the predicate device.

Note: The primary performance mentioned is the stated cutoff concentration of 10 ng/ml. The document states that a negative specimen produces two distinct color bands, and a positive specimen produces only one color band in the control area when the drug is above the detection level of 10 ng/ml. This outlines the expected visual interpretation.

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

The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts and Qualifications for Ground Truth

The provided text does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The provided text does not specify any adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted based on the provided text. The device is a "one-step strip test" with visual interpretation, and the comparison is primarily to laboratory-based methods (CEDIA assay and GC/MS).

6. Standalone Performance

Yes, a standalone performance assessment was done. The device's performance is described in terms of its ability to detect buprenorphine at a specific cutoff concentration (10 ng/ml) through a visual read. The comparison study evaluates this standalone performance relative to established methods.

7. Type of Ground Truth Used

The ground truth for comparison is primarily established by:

• Predicate Device: The CEDIA® Buprenorphine Assay (K040316).
• Confirmatory Method: Gas Chromatography/Mass Spectrometry (GC/MS) is explicitly stated as the preferred confirmatory method.

This implies that GC/MS serves as the gold standard or reference method for confirming the presence or absence of buprenorphine in samples.

8. Sample Size for the Training Set

The provided text does not specify the sample size for the training set. This is a point-of-care, visually read immunoassay device, and typically, such devices are developed/calibrated using laboratory testing rather than traditional machine learning training sets.

9. How Ground Truth for the Training Set was Established

The provided text does not explicitly describe how ground truth for a "training set" was established. Given the nature of the device (a qualitative immunoassay), the development likely involved:

• Spiking studies: Urine samples would be spiked with known concentrations of buprenorphine to determine the device's analytical sensitivity and cutoff performance.
• Comparison to reference methods: Similar to the test set, initial development and optimization would likely involve comparing the strip test results to established laboratory methods like GC/MS to confirm accuracy at various concentrations.

The mechanism of the device itself (competition with antibody sites resulting in color band formation) indicates its operational principle is based on known chemical reactions, not on learning from a "training set" in the context of AI or machine learning.

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