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The QuickScreen™ Benzodiazepines Test is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine. The cutoff concentration for this test is 200 ng/ml. This assay is intended for professional use.

The QuickScreen Benzodiazepines Test is an in-vitro diagnostic screen that provides a qualitative detection of benzodiazepines in urine. It is intended for professional use only.

An invitro diagnostic test for the qualitative detection of amphetamine, cocaine, methamphetamine, opiates, PCP, benzodiazepines, barbiturates, methadone and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse. It is intended for professional use only.

Immunoassay for the qualitative detection of Benzodiazepines in urine

The QuickScreen™ Benzodiazepines Test, like many commercially available oxycodone screening test kits, qualitatively measures the presence of benzodiazepines by visual color sandwich one step immunoassay technology. These devices rely on the basic immunochemical sandwich assay principle of recognition of specific antibody / target analyte / antibody / complexes.

The Phamatech QuickScreen™ Benzodiazepines Test (Models 9025, 9026, 9027T, 9153 and 9195X) is a rapid, qualitative immunoassay for the detection of benzodiazepines in urine, with a cutoff concentration of 200 ng/ml. The device's performance was evaluated through a clinical sample correlation study and a blind labeled spiked study.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The document mentions "clinical sample correlation study" and "blind labeled spiked study" but does not provide the exact number of samples used in either study.
• Data Provenance: The document states "Laboratory studies, using clinical specimens," which implies the data is from prospective clinical samples. The country of origin is not specified but given the manufacturer (Phamatech, San Diego, California, USA) and the FDA filing, it's highly likely to be from the USA.

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

• This information is not provided in the document. The study compared the device's performance against "predicate devices," suggesting the predicate device's results were used as the reference or "ground truth," rather than expert adjudication of the samples themselves.

4. Adjudication Method for the Test Set

• None explicitly described in terms of expert adjudication. The study design indicates a comparison to "predicate devices," implying the results generated by these established devices served as the reference standard.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a qualitative immunoassay for drug detection, where the reading is typically a direct visual interpretation (e.g., presence or absence of a line) and not subject to the same kind of reader variability or interpretation as imaging studies.
• Therefore, the effect size of how much human readers improve with AI vs without AI assistance is not applicable to this type of device.

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

• Yes, the performance reported is inherently standalone. The QuickScreen™ Benzodiazepines Test is a single-step immunoassay that provides a visual qualitative result. The reported 97.9% correlation is the performance of the device itself (algorithm/assay only) when compared to predicate devices. There is no "human-in-the-loop" aspect to its core diagnostic function; the human merely reads the visual output.

7. The Type of Ground Truth Used

• The ground truth used was the results from predicate devices. The study achieved a "97.9% correlation when compared to the predicate devices." This implies that the performance of existing, legally marketed benzodiazepine screening tests was used as the reference standard against which the QuickScreen™ Benzodiazepines Test was evaluated.

8. The Sample Size for the Training Set

• This information is not provided in the document. As an immunoassay, the device itself doesn't typically undergo "training" in the sense of machine learning algorithms. Its design and manufacturing are established, and then its performance is validated.

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

• This information is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" with established ground truth. Its performance characteristics are inherent to its chemical and biological design.

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