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The FaStep™ Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed 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 FaStep™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each FaStep™ Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

The provided text is a 510(k) summary for the FaStep™ Fentanyl Rapid Test Device (Urine), an in vitro diagnostic device. It details the device's technical specifications and performance characteristics through analytical and lay-user studies. It does not describe a clinical study comparing human readers with and without AI assistance (MRMC study), nor does it involve the use of AI. Therefore, the information typically associated with acceptance criteria and studies for AI-powered devices, such as specific performance metrics like AUC, sensitivity, specificity for diagnostic accuracy in a clinical setting, or expert consensus and adjudication methods for ground truth, is not directly applicable or present in this document.

However, I can extract the relevant information from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria, adapting to the context of a rapid diagnostic test.

Here’s the breakdown based on the provided text, focusing on the analytical and lay-user performance of the rapid immunoassay:

Acceptance Criteria and Device Performance (Adapted for a Rapid Diagnostic Test)

The primary performance evaluation in this document centers around the device's ability to accurately detect fentanyl in urine at a specific cut-off concentration (1.0 ng/mL) under various conditions. The "acceptance criteria" are implied by the desired accuracy rates at and around this cut-off, as demonstrated in the precision and lay-user studies.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set (Precision Study): For each concentration level, 60 tests were performed (2 tests/day for 10 days per device lot, across 3 lots). Thus, for each concentration, 180 total tests (60x3) were conducted across the three lots combined. The document mentions urine samples were "prepared by spiking fentanyl in negative samples." This suggests a controlled laboratory setting.
• Test Set (Lay-User Study): 140 lay persons participated, each testing one blind-labeled sample. A total of 140 samples were tested (20 per concentration level for 7 levels).
• Test Set (Method Comparison Study): 82 unaltered clinical samples (42 negative and 40 positive) were used.
• Data Provenance: The document does not explicitly state the country of origin for the samples or if they were retrospective or prospective patient samples. However, the use of "spiked" samples and "unaltered clinical samples" suggests a mix, likely from a laboratory and potentially local clinical collection. The "Method Comparison Study" description implies retrospective use of clinical samples ("unaltered clinical samples").

3. Number of Experts and Qualifications for Ground Truth:

• For Precision, Interference, Specificity Studies: The ground truth for these analytical studies was established by preparing samples with known concentrations of fentanyl or interfering substances, verified by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate and accepted laboratory method for quantification, rather than relying on human experts for reading.
• For Method Comparison Study: Ground truth was established by LC/MS results.
• For Lay-User Study: Ground truth for the spiked samples was established by LC/MS.

4. Adjudication Method for the Test Set:

• For the analytical studies (precision, interference, specificity), the ground truth was concentrations confirmed by LC/MS, so an 'adjudication' in the human-reader sense is not applicable. The device's result (positive/negative) was compared directly to the LC/MS confirmed concentration.
• For the method comparison study, the results of the FaStep device were compared against LC/MS results. The "Discordant Results" table shows where the device result did not match the LC/MS result, demonstrating the instances where reconciliation (if any) might happen in a real-world scenario, but no formal adjudication process between human readers is described for this specific device.

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

• No, an MRMC comparative effectiveness study was NOT done. This document describes the performance of a rapid diagnostic test (an immunoassay), not an AI algorithm assisting human readers in interpreting medical images or data. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. Standalone Performance:

• Yes, a standalone performance study was done. The entire analytical performance section (Precision, Interference, Specificity, Effect of Urine Specific Gravity and pH) and the lay-user study demonstrate the performance of the device itself without human intervention in terms of interpretation beyond visual reading of the test line. The device autonomously produces a "positive" or "negative" line.

7. Type of Ground Truth Used:

• The primary ground truth used for performance validation was LC/MS (Liquid Chromatography/Mass Spectrometry) confirmed concentrations. This is a highly accurate chemical analytical method considered the gold standard for drug detection and quantification in biological samples.

8. Sample Size for the Training Set:

• Not applicable in the context of an immunoassay device. This device is a chemical immunoassay, not a machine learning or AI algorithm that requires a "training set" to learn. The device's components and design are established during manufacturing, not through machine learning.

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

• Not applicable. As explained above, this device does not utilize a training set in the AI/machine learning sense.

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