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The ACS:180 and ADVIA Centaur Theophylline 2 Immunoassays are competitive, chemiluminescence immunoassay for the quantitative determination of theophylline in human serum and plasma for use on the automated analyzer manufactured by Bayer Corporation. Theophylline (1,3-dimethylxanthine) is a potent bronchodilator and is very important in the treatment of asthma. Monitoring a patient's theophylline level is very important in reducing the risks of over or under-medication resulting from the wide inter-patient variation in theophylline absorption, metabolism and excretion. The ACS and ADVIA Centaur Theophylline 2 immunoassays are used as an aid to monitor a patient's theophylline level.

The ACS and ADVIA Centaur Theophylline 2 are competitive chemiluminescence immunoassays are intended for the quantitative determination of theophylline in human serum and plasma. Theophylline in the patient sample, calibrators, standards and controls competes with acridinium ester-labeled theophylline in the Lite Reagent for a limited amount of monoclonal mouse anti-theophylline antibody, which is covalently coupled to paramagnetic particles in the Solid Phase. Following incubation, unreacted acridinium esterlabeled theophylline and unreacted theophylline from the sample are washed from the reaction mixture. The chemiluminescence of the reacted, labeled theophylline is measured in a luminometer. The measured chemiluminescence is inversely proportional to the quantity of theophylline in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bayer Diagnostics Theophylline 2 Immunoassays:

Acceptance Criteria and Device Performance Study for Bayer Diagnostics Theophylline 2 Immunoassays

The submission describes the substantial equivalence of the new ACS and ADVIA Centaur Theophylline 2 Immunoassays to the predicate ACS Theophylline assay. The primary method for demonstrating this equivalence is through method comparison studies, which establish correlation between the new devices and the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implied by the "substantial equivalence" claim and the reported correlation results, which generally aim for a high correlation coefficient (close to 1) and slopes close to 1 with intercepts close to 0, indicating strong agreement between methods.

Interpretation: All reported correlation coefficients are 0.99, demonstrating excellent agreement. The slopes are close to 1 (0.94, 1.00, 1.05) and intercepts are relatively small (-0.24, -0.9, 1.36), indicating that the new assays perform very similarly to the predicate and to each other.

2. Sample Size and Data Provenance

• Sample Size for Test Set: N = 138 for each comparison.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be human serum and plasma samples based on the intended use.

3. Number of Experts and Qualifications for Ground Truth

• This type of immunoassay study typically does not involve human experts to establish "ground truth" in the way, for example, an imaging study would for disease diagnosis.
• The "ground truth" or reference standard for comparison in this context is the predicate device's performance (ACS Theophylline Assay, K951169). The assumption is that the predicate device's measurements are a reliable reference.

4. Adjudication Method

• None applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where multiple experts independently review cases to establish a consensus ground truth, often for subjective assessments or complex diagnoses. This is not relevant for an immunoassay comparison study where numerical values are being compared.

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

• No. An MRMC study is not mentioned and would not be applicable to an immunoassay device. MRMC studies are used to evaluate the impact of human readers (e.g., radiologists, pathologists) on diagnostic accuracy, often with and without AI assistance. This device is a standalone diagnostic test that produces a quantitative result.

6. Standalone (Algorithm Only) Performance

• Yes. This entire study evaluates the standalone performance of the new immunoassay devices. They are designed to provide quantitative results directly from serum or plasma samples. There is no human-in-the-loop performance component described; the devices measure theophylline levels directly.

7. Type of Ground Truth Used

• Comparison to a Predicate Device's Measurements: The ground truth for this evaluation is defined by the measurements obtained from the existing, legally marketed ACS Theophylline Assay (predicate device K951169). The study seeks to prove that the new devices provide equivalent measurements to this established predicate.

8. Sample Size for Training Set

• Not explicitly stated/not applicable in this context. Immunoassays, by their nature, are typically developed and optimized during formulation and manufacturing, and then validated through performance studies like method comparisons. The term "training set" is more commonly associated with machine learning algorithms. While there would have been internal development and validation during the assay optimization phase, it's not described as a "training set" in the context of this 510(k) submission.

9. How Ground Truth for Training Set was Established

• Not applicable/Not described. As mentioned above, the concept of a "training set ground truth" as used in machine learning is not directly applicable here. The "ground truth" in the validation study refers to the results from the established predicate device. For the development and initial calibration of the new assays, it would typically involve using reference materials with known concentrations of theophylline.

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