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The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy.

This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Theophylline Test Kit is an in vitro diagnostic reagent for the quantitative determination of theophylline in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Latex particles are coated with theophylline which, in the presence of theophylline antibody solution, rapidly agglutinate. When a sample containing theophylline is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agdutination is inversely dependent on the concentration of theophylline in the sample. By monitoring the change in scattered light as a change in absorbance, a concentration curve can be obtained. The actual change in absorbance is inversely proportional to the concentration of theophylline in the sample.

This document is an FDA 510(k) clearance letter for the Randox Laboratories Ltd. Theophylline Test Kit. It lacks the kind of detailed study information you requested for Artificial Intelligence/Machine Learning (AI/ML) powered medical devices. The document refers to a "Theophylline Test System" which is an in vitro diagnostic reagent, not an AI/ML device. Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

However, I can provide the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain acceptance criteria or detailed performance data in a table format. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary regulatory hurdle for 510(k) submissions.

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

Not applicable/Not provided. This is an in vitro diagnostic test for a chemical compound, not an imaging/AI device requiring patient data in the typical sense for an AI model.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. For this type of in vitro diagnostic test, the "ground truth" would be established through analytical validation methodologies, not expert consensus on patient data.

4. Adjudication Method

Not applicable.

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

Not applicable. This is not an AI/ML device, and MRMC studies are typically used for evaluating the impact of AI assistance on human readers interpreting medical images.

6. Standalone (Algorithm Only) Performance Study

The device itself is a standalone in vitro diagnostic test. Its performance would be evaluated through analytical studies (e.g., accuracy, precision, linearity, interference) rather than "algorithm only" performance in the context of AI. The document itself does not contain this detailed performance study data, but rather the FDA's decision based on such submissions.

7. Type of Ground Truth Used

For this type of in vitro diagnostic device, the "ground truth" would be established through:

• Reference Methods: Comparison to established, highly accurate analytical methods for theophylline quantification.
• Known Concentrations: Testing samples with known, precise concentrations of theophylline.
• Clinical Correlation: Demonstrating that the test results correlate with actual patient conditions related to theophylline levels.

The specific "ground truth" for the studies submitted for this 510(k) is not detailed in this clearance letter.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses a "training set" in the conventional sense.

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

Not applicable.

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