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The ARCHITECT i Theophylline assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of theophylline in human serum or plasma on the ARCHITECT i System with STAT protocol capability. Theophylline is used in the treatment of bronchospasm associated with bronchial asthma, chronic bronchitis and pulmonary emphysema. The measurements obtained are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to help ensure appropriate therapy.

The ARCHITECT i Theophylline Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of theophylline in human serum and plasma.

The ARCHITECT iTheophylline assay is a one-step STAT immunoassay for the quantitative determination of theophylline in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex.

Sample, anti-theophylline coated paramagnetic microparticles, and theophylline acridinium-labeled conjugate are combined to create a reaction mixture. The antitheophylline coated microparticles bind to theophylline present in the sample and to the theophylline acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of theophylline in the sample and the RLUs detected by the ARCHITECT / System optics.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document provided does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics like precision, linearity, and interference. Instead, it uses the phrase "substantially equivalent" to a predicate device (AxSYM® Theophylline II) as the primary measure of a successful evaluation.

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

The document does not explicitly state the sample size used for the test set in the clinical performance study. It only mentions the "non-clinical performance data" and "clinical performance" without specifying the number of samples or patients involved.

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

This information is not applicable and not provided in the document. The "ground truth" for a quantitative diagnostic test like theophylline measurement is typically established by comparison to a reference method (in this case, the predicate device results), not by expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used when subjective interpretations are involved, such as in imaging studies. For a quantitative immunoassay, the comparison is directly with the results of the predicate method.

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 type of study is relevant for evaluating human interpretation with and without AI assistance, which is not the nature of this submission for a fully automated immunoassay.

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

Yes, the performance described is a standalone (algorithm only) performance. The ARCHITECT i Theophylline assay is an automated chemiluminescent microparticle immunoassay, meaning its performance is evaluated directly without human interpretation influencing the measurement itself. The comparison is between the new automated system and the existing automated predicate system.

7. The Type of Ground Truth Used

The "ground truth" or reference standard used for comparison was the results obtained from the AxSYM® Theophylline II assay. This is a legally marketed predicate device, and the new device's performance is gauged by its correlation and equivalence to this established method.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an immunoassay like this, the development process (which could be considered analogous to "training") would involve various experiments for reagent optimization, calibration curve fitting, and assay parameter setting, but these are generally not referred to as a "training set" in the same way as machine learning models. The performance assessment is against clinical samples or spiked samples, but the number of these used for initial method development versus final validation is not detailed.

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

Since a "training set" in the machine learning sense is not explicitly discussed, the concept of establishing ground truth for it is also not addressed. The development of the assay itself would rely on established laboratory practices, analytical standards, and potentially comparison to existing reference methods during its initial R&D phase, leading to the optimized assay parameters and reagents that are then validated against the predicate device.

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