Search Results

The Alinity o Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay intended for the qualitative and/or semiquantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL (0.700 umol/L) on the Alinity c analyzer.

The assay is intended to be used in laboratories and provides a rapid analytical screening procedure to detect benzodiazepines in human urine. This assay is calibrated against oxazepam. This product is intended to be used by trained professionals only.

The semiquantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Tandem Mass Spectrometry (LC- MS/MS) or permitting laboratories to establish quality control procedures.

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) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/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. For In Vitro Diagnostic Use Only.

The Alinity c Benzodiazepines Reagent Kit is a homogeneous enzyme immunoassay with liquid ready to-use reagents. The assay uses a specific antibody that can detect most benzodiazepines and their metabolites in urine. The assay is based on competition between a drug labeled with glucose-6- phosphate dehydrogenase (G6PDH), and free sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the specific antibody binds the druq labeled with G6PDH and causes a decrease in enzyme activity. In the presence of free drug occupies the antibody binding sites, allowing the drug bound G6PDH to interact with the substrate, resulting in enzyme activity. This phenomenon creates a direct relationship between the drug concentration in urine and enzyme activity is determined spectrophotometrically at 340 nm by measuring the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.

Benzodiazepines are sedative-hypnotic drugs, which are subject to abuse. Benzodiazepines are include a wide variety of drugs such as alprazolam, diazepam, lorazepam, oxazepam, and triazolam. They are absorbed and metabolized at different rates, resulting in various psychoactive effects. Baselt describes the metabolism and toxicology of numerous benzodiazepines, including alprazeoam, chlordiazepoxide, clobazam, clorazepate, diazepan, estazolam, flunitrazepam, halazepam, medazepam, midazolam, nitrazepam, oxazepam, prazepam, quazepam, temazepam, and triazolam.

The Alinity c Benzodiazepines Reagent Kit is a first-line device, which may be used by medical personnel, along with clinical observations, as an aid for indicating Benzodiazeoine abuse through detection of benzodiazepines or their metabolites in urine

The document provided is a 510(k) Premarket Notification for an in vitro diagnostic device, the Alinity c Benzodiazepines Reagent Kit. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria for an AI model.

Therefore, many of the requested details regarding AI model acceptance criteria, ground truth establishment, expert adjudication, MRMC studies, and training/test set sample sizes for an AI study are not present in this document. This document describes the performance characteristics of a laboratory immunoassay, which is a chemical assay, not an AI or software algorithm that interprets images or complex data.

However, based on the provided text, I can extract the following information relevant to the device's analytical performance and its comparison to a predicate, which serves as a form of "acceptance criteria" for a diagnostic kit:

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

The document doesn't explicitly state "acceptance criteria" in a typical table format for an AI model's performance metrics (e.g., sensitivity, specificity, AUC with predefined thresholds). Instead, it describes the performance observed and compares it to a predicate device, often noting if they are "identical" or "substantially equivalent." The performance data presented are for specific analytical studies of the reagent kit.

Here's an attempt to structure the performance characteristics as reported, which act as the evidence for "acceptance" (i.e., substantial equivalence):

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size:

  • Accuracy and Method Comparison: The document states that the Alinity c Benzodiazepines Reagent Kit demonstrated "equivalent performance" when compared to LC-MS/MS, yielding "positive agreement was 100.00%, negative agreement was 96.96%, and overall agreement was 98.41%". While percentages are given, the absolute number of samples used for this accuracy study is not explicitly stated in the provided text.
  • Accuracy by Recovery and Dilution Linearity: A "series of samples" were analyzed, but the specific number is not stated.
  • Precision (Within-Laboratory and Reproducibility): The percentages of correctly read samples are given, but the underlying number of samples/tests performed is not explicitly stated.
  • On-Board Reagent Stability: "one lot" was used, but the number of tests or samples is not explicitly stated.

• Data Provenance (country of origin, retrospective/prospective): Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as this is an in vitro diagnostic (IVD) chemical assay, not an AI product requiring expert review of medical images or data for ground truth. The ground truth for chemical assays is typically established by a reference method.

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

Not applicable, as this is an IVD chemical assay, not an AI product. Ground truth is established by a reference method.

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:

Not applicable, as this is an IVD chemical assay, not an AI product involving human readers.

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

The device (Alinity c Benzodiazepines Reagent Kit) is a standalone diagnostic test (specifically, an enzyme immunoassay) that provides results without human interpretation of raw assay data. The results (qualitative or semiquantitative determination of benzodiazepine presence) are generated by the Alinity c analyzer using the reagent kit. This is inherently a "standalone" analytical performance.

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

For the Accuracy and Method Comparison study, the reference method (ground truth) used was Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS). This is explicitly stated: "The Alinity c Benzodiazepines Reagent Kit demonstrated equivalent performance on the Alinity c analyzer when compared to the reference LC-MS/MS". The document also mentions GC/MS or LC-MS/MS as the "preferred confirmatory method" in the Indications for Use.

8. The sample size for the training set:

Not applicable. This is an IVD chemical assay; there is no "training set" in the context of machine learning model development. The assays are developed and validated using a different process than AI models.

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

Not applicable, as there is no training set for an AI model. For the chemical assay, "ground truth" for development and validation would involve well-characterized samples and reference methods like LC-MS/MS. The calibrators and controls for the assay are stated to contain Oxazepam and are traceable to a commercial source with 98% purity.

Ask a specific question about this device