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The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices are qualitative lateral flow immuno-chromatographic competitive urinary rapid in vitro diagnostic (IVD) qualitative assays for detection of Benzodiazepines drugs, and metabolites (BZD) in human urine at the NIDA (National Institute of Drug Abuse) cut-off of 300 ng BZD/ml. The cut-off for both LiveSure™ Test Card and Test Strip device methods has been set at 300 ng BZD drug/ml based upon calibration using the parent benzodiazepine/BZD drug, and using Oxazepam standards with a GC/MS method for the quantitation of all the Oxazepam standard and urine test solutions. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe Biotech LiveSure™ BZD Screen Tests for BZD provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA recommends gas chromatography/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The Pan Probe Biotech LiveSure™ Benzodiazepines Screen Test Card and Test Strip (i.e., LiveSure™ BZD Screen Tests) devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug conjugate competes with any Benzodiazepine (BZD) drugs, analogs or metabolites that may be present in test urine samples for limited specific antibody binding sites. LiveSure™ Benzodiazepines devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is pre-labeled with specific monoclonal antibody from mouse directed against BZD drugs. The Test Strip and Test Card consists of a membrane absorbent pad having a gold-probe-conjugate pre-labeled with specific monoclonal antibody from mouse that is directed against BZD drugs, and a chromatographic membrane pre-coated with a chemically modified Benzodiazepine (Oxazepam) drug-conjugate as a capture reagent. The Test region of each device has been layered with a Benzodiazepine [Oxazepam] drug-conjugate as a 1st capture reagent, while the Process Control region has been pre-coated with a 2nd anti-mouse antibody reagent derived from goat. A pink colored anti-BZD monoconal antibody-colloidal gold conjugate pad is placed to the right of a test strip. In the absence of BZD drugs, analogs or metabolites in urine, pink colored antibody-colloidal gold conjugates move chromatographically along with the urinary samples on the membrane by capillary action. Antibody-colloidal gold conjugate binds to BZD-drug conjugate, forming an antibody-antigen complex. This antibody-BZD-drug conjugate appears as second visible pink colored band and captured reagent at the test region. Any BZD drugs, analogs or metabolites that are present in a sample urine act as antigens, competing with BZD-drug conjugate at the test band region for limited BZD-antibody binding sites on antibody-colloidal gold conjugate. When a sufficient concentration of urinary BZD drugs, analogs or metabolites are present, these analytes block the limited antibody binding sites. This blockage-binding prevents attachment of pink colored antibody-colloidal gold conjugate at the BZD-drug conjugate zone located at the test band region. To serve as a procedural control, a pink colored band in a control region will always appear, regardless of the presence of BZD in urine samples. Thus, negative urine samples produces two pink colored bands, while positive urine samples produce only one pink colored band.

Let's break down the acceptance criteria and study details for the LiveSure™ Benzodiazepines Screen Tests based on the provided 510k submission.

Acceptance Criteria and Device Performance

The provided document describes the performance of the LiveSure™ Benzodiazepines Screen Test Card and Test Strip devices compared to a predicate device (EMIT® II Assay) and a gold standard (GC/MS). While "acceptance criteria" isn't explicitly listed in a numbered format, the submission implies acceptance based on agreement rates and accuracy compared to these benchmarks, particularly around the NIDA/SAMHSA cut-off.

Here's a table summarizing the implied acceptance criteria and reported performance:

Study Details

The submission describes a clinical testing study that supports the device's performance.

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

   • Sample Size: 387 urine samples.
   • Data Provenance: The independent clinical testing was performed at an "external reference laboratory," suggesting the data is derived from a clinical setting, presumably in the country where the external reference laboratory operates (not explicitly stated, but typically assumed to be the US for a 510k submission). The data is retrospective, as existing urine samples were tested.

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

   • The document does not explicitly state the number of experts or their qualifications for establishing the ground truth. However, the ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is an analytical laboratory method, not a human expert interpretation.

3. Adjudication method for the test set:

   • Not applicable. The ground truth was established by quantitative GC/MS, an objective analytical method, not by expert consensus requiring adjudication.

4. 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:

   • No. This is a rapid qualitative immunoassay for drug screening, not an AI-assisted diagnostic device that would typically involve a multi-reader, multi-case study. The device is read visually by a professional, and its performance is compared to lab-based methods.

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

   • Yes, in a sense. The LiveSure™ devices are "standalone" in that they provide a qualitative visual result directly from the sample without further human interpretation beyond reading the positive/negative bands. Their performance was evaluated as such. The "human-in-the-loop" is the professional interpreting the visual bands.

6. The type of ground truth used:

   • GC/MS quantitative positive results and GC/MS negative results. GC/MS is widely considered the "gold standard" for confirmatory drug testing due to its high specificity and sensitivity.

7. The sample size for the training set:

   • The submission does not explicitly mention a separate "training set" or its size. The "in-house testing" against the EMIT® II Assay might represent an internal validation or development phase, but it's not detailed as a distinct training set for a machine learning model, which is not applicable here. The primary performance data relies on the 387 clinical samples.

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

   • Not applicable, as a distinct training set (in the context of machine learning) is not described. For any internal development or optimization, the ground truth would likely also be established using GC/MS or similar validated methods, but this is not specified.

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