Search Results

AllTest Fentanyl Urine Test Cassette is is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides 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. For in vitro diagnostic use only.

AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and study details for the AllTest Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on the lay user study demonstrating accurate detection of fentanyl at various concentrations relative to the 1 ng/mL cutoff. The reported device performance is indicated by the percentage of correct results from the lay user study, demonstrating high accuracy across different spiked concentrations.

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: 140 lay persons participated in the study. Each participant tested one sample, resulting in 140 test results. The samples were prepared at 7 different concentrations, with 20 samples per concentration level.
   • Data Provenance: The data provenance is not explicitly stated as a country of origin for the prepared samples or participants. The study was performed "at three intended user sites," implying it was conducted specifically for this application, making it a prospective study. The samples were "spiked fentanyl into drug free-pooled urine specimens."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
   • The ground truth for the prepared samples was confirmed by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method, which serves as the gold standard for confirming drug concentrations.

3. Adjudication Method for the Test Set:

   • No adjudication method (e.g., 2+1, 3+1) was explicitly performed for the lay user results. The results are reported directly from the lay person's interpretation.
   • However, the ground truth of the samples was established by LC/MS, acting as the definitive reference.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. A traditional MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed. This device is a standalone diagnostic test, not an AI-powered image analysis tool. The lay user study focused on the device's performance when used by individuals with no special training.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Yes, in essence, the "algorithm" is the test cassette itself. The lay user study is testing the standalone performance of the device when used by a lay person, without expert intervention or interpretation during the test execution. The accuracy of the device's output is directly assessed against the LC/MS confirmed concentrations.

6. The Type of Ground Truth Used:

   • The ground truth for the test samples was LC/MS confirmation. This is a highly reliable and recognized analytical method for determining drug concentrations.

7. The Sample Size for the Training Set:

   • The document does not provide details about a specific "training set" for the device itself or any underlying machine learning model. This is an immunoassay device, not typically requiring a training set in the context of AI/ML. The analytical performance (sensitivity, specificity, etc.) would have been established through laboratory studies, but specific training set details for those are not given here. The document states: "See analytical performance in predicate K231698," implying that foundational analytical characteristics were established elsewhere.

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

   • As no specific "training set" for an AI/ML model is mentioned, this question is not directly applicable. For the analytical performance mentioned, it would typically be established using known, precisely prepared samples with confirmed concentrations (similar to the LC/MS confirmation for the lay user study samples).

Ask a specific question about this device