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The Abbott Aeroset® Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma on the Abbott Aeroset® System.

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990.

Syva Company is submitting the Premarket Notification, 510(k) on behalf of Abbott Laboratories to convey Abbott's intention to commercially market an in vitro diagnostic reagent test kit for the analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay is a homogenous enzyme assay intended for use in quantitative analysis of theophylline in human serum or plasma. The Abbott Aeroset® Theophylline Assay and calibrators has been found to be equivalent to the predicate device: Emit® 2000 Theophylline Assay (K913123) with regard to intended use, assay sample, and overall performance characteristics.

The Abbott Aeroset Theophylline Assay is a homogeneous enzyme immunoassay intended for the quantitative analysis of theophylline in human serum or plasma. The assay is intended to be substantially equivalent to the Emit 2000 Theophylline Assay (K913123).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document describes performance for two key areas: comparative analysis and precision. It establishes that "excellent correlation" and "acceptable" precision are the acceptance criteria, comparing the Abbott Aeroset Theophylline Assay to the predicate device, the Emit® 2000 Theophylline Assay (K913123).

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The document mentions "comparative analysis" and "Precision study" but does not provide the number of samples or subjects used in these studies.
• Data Provenance: Not explicitly stated. There is no mention of the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

• Not applicable for this type of in vitro diagnostic device (immunoassay). The "truth" is established by the reference method (predicate device) and analytical measurements, not by expert consensus on visual interpretation.

4. Adjudication Method for the Test Set

• Not applicable. The quantitative nature of the assay and comparison to a predicate device does not involve adjudication by experts.

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

• Not applicable. This is an in vitro diagnostic device, not an imaging or diagnostic interpretation aid that would involve human readers.

6. Standalone Performance Study

• Yes, a standalone performance study was done in the sense that the Abbott Aeroset Theophylline Assay's performance (precision) was evaluated independently. However, its primary "standalone" claim is substantial equivalence to a predicate device, meaning its performance is considered acceptable if it correlates well with the established predicate. The precision study evaluates the device's inherent variability.

7. Type of Ground Truth Used

• Predicate Device/Reference Method: For the comparative analysis, the "ground truth" or reference was the Emit® 2000 Theophylline Assay (K913123). This is a legally marketed predicate device with established performance.
• Analytical Measurement: For the precision study, inherent analytical measurements of samples at different concentrations were used to determine the variability (%CV).

8. Sample Size for the Training Set

• Not applicable. This device is an immunoassay reagent kit, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of the assay is inherent in its chemical and biological design, and its calibration is part of its routine use rather than an external training phase for an algorithm.

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

• Not applicable, as there is no "training set" in the context of a machine learning algorithm. The assay's performance characteristics, including its analytical range and accuracy, are established through internal validation studies by the manufacturer and comparison to a predicate device, as described.

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