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Immunalysis Oxycodone Urine Enzyme Immunoassay:

The Immunalysis Oxycodone Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 100ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Oxycodone in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxycodone. This in-vitro device is for prescription use only.

The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.

The Immunalysis Oxycodone Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Immunalysis Oxycodone Urine Controls:

The Immunalysis Oxycodone Urine Controls are used as control materials in the Immunalysis Oxycodone Urine Enzyme Immunoassay.

Immunalysis Oxycodone Urine Calibrators:

The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Oxycodone in urine on automated clinical chemistry analyzers.

The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes recombinant monoclonal antibodies to Oxycodone, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes oxycodone derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use

The oxycodone calibrator and controls consists of a single calibrator at 100ng/mL or 300ng/mL, a control set containing a LOW control (75ng/mL or 225ng/mL) and a HIGH control (125ng/mL or 375ng/mL) and a calibrator set containing a negative calibrator, a Level 1 calibrator at 100ng/mL, a Level 2 calibrator at 300ng/mL, a Level 3 calibrator at 500ng/mL and a Level 4 calibrator at 1000ng/mL.

Here's a breakdown of the acceptance criteria and study information for the Immunalysis Oxycodone Urine Enzyme Immunoassay, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity thresholds) or specific numerical performance metrics in a readily digestible format for the Immunalysis Oxycodone Urine Enzyme Immunoassay. However, it mentions several laboratory performance studies conducted to establish "substantial equivalence" to the predicate device. These study types implicitly represent areas where the device performance was evaluated.

While no precise acceptance criteria (e.g., "sensitivity must be >95%") are given, the comparison table between the predicate and the test device indicates that the "Cutoff Levels" are identical (100ng/mL and 300ng/mL of Oxycodone). This suggests that the device's ability to accurately detect beyond these cutoffs is a key performance metric. The "Conclusion" section states the device is "safe and effective for its intended use" and "substantially equivalent" to the predicate, implying that its performance in the conducted studies met the unstated acceptance criteria for these categories.

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

The provided text does not explicitly state the sample size used for any of the test sets (Precision/Cutoff Characterization, Specificity, Interference, Linearity, Method Comparison, Stability).

The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of sample collection).

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

The provided text does not mention the use of experts to establish ground truth for the test set. For an in-vitro diagnostic device like this, ground truth is typically established through reference methods (like GC-MS or LC/MS) rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method like 2+1 or 3+1. For in-vitro diagnostic assays, adjudication methods are less common, as analytical results are compared to a more definitive reference method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in the provided text. This type of study is more relevant for imaging devices where human readers interpret results, and the AI's impact on their performance is directly measured. This device is an automated immunoassay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The studies described (Precision, Specificity, Interference, Linearity, Method Comparison, Stability) are inherent to the standalone performance of the assay itself. The immunoassay is an automated system designed to produce results, and the listed studies directly evaluate its analytical capabilities. Therefore, a standalone performance evaluation was done through these studies, as there isn't a "human-in-the-loop" component in the assay's primary function. The output is a preliminary analytical test result.

7. Type of Ground Truth Used

The ground truth used for performance evaluation is implicitly through a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS). The intended use statement explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method." This indicates that these methods serve as the gold standard for confirming oxycodone presence and concentration.

8. Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is an immunoassay, which relies on chemical reactions and optical detection, not a machine learning or AI algorithm that typically requires a distinct training set. The "assay" itself is the "algorithm" in a sense, and its formulation and optimization would precede these validation studies.

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

Since no specific "training set" for an AI or machine learning model is mentioned, the text does not describe how ground truth for a training set was established.

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