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The Emit® 2000 Valproic Acid Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of valproic acid in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of valproic acid overdose or in monitoring levels of valproic acid to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.

The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.

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

The provided document, K011947, is a 510(k) summary for the Emit® 2000 Valproic Acid Assay. It describes a modified assay that is primarily a packaging change compared to a predicate device. The core assay performance characteristics are stated to be the same as the predicate device. This is a crucial point, as much of the performance data relies on the equivalence to the predicate.

Given this context, the document does not explicitly state specific numerical acceptance criteria for the modified device's performance, nor does it detail a standalone study generating new performance metrics for this specific modified version. Instead, the submission relies on the assertion that the "assay performance characteristics" are identical to the predicate device. Therefore, the "reported device performance" for the modified device is implicitly assumed to be the same as the predicate.

The document focuses on substantiating that the packaging changes do not alter performance.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, specific numerical acceptance criteria for the modified device's analytical performance (e.g., accuracy, precision, linearity) are not explicitly stated in this 510(k) summary. The submission argues for substantial equivalence based on the modified device having the "same operating principles, design, manufacturing materials, method of manufacture, assay performance characteristics and intended use as the predicate device." Therefore, the de facto acceptance criteria are that the modified device's performance is demonstrably unchanged from the predicate device due to the packaging modifications, or that it continues to meet the performance established for the predicate.

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

The 510(k) summary does not provide details for a specific test set with sample sizes for the modified device's performance. The submission is based on the premise that the assay capabilities are identical to the predicate. The "study" here is more of a comparison of device characteristics rather than a new performance study.

• Sample Size for Test Set: Not specified, as no new performance study data is presented for the modified device itself.
• Data Provenance: Not applicable in the context of new performance data for the modified device. The "data" refers to the established equivalence of the components and the assay principles.

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

Not applicable. This device is an in-vitro diagnostic (IVD) assay for measuring a specific analyte concentration. Ground truth for such assays is typically established through a reference method or validated calibrators, not through human expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD assay measuring an analyte, there is no "adjudication method" in the sense of expert review for ambiguous cases. Performance is typically assessed through analytical validation (e.g., linearity, precision, accuracy against reference methods).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for devices involving human interpretation (e.g., medical imaging devices). This is an IVD assay, not requiring human interpretation of complex outputs.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in an implicit sense. The "device" (the reagents) functions as an automated system on an analyzer. The intent of the submission is to demonstrate that the reagents themselves perform identically to the predicate reagents, without human intervention affecting the analytical result. The performance of the predicate device would have been established as a standalone analytical system.

7. The Type of Ground Truth Used

For the predicate device (and by extension, the modified device), the ground truth for Valproic Acid concentration would typically be established by:

• Reference Methods: Such as Gas Chromatography-Mass Spectrometry (GC-MS) or High-Performance Liquid Chromatography (HPLC), which are highly accurate and precise methods for determining drug concentrations.
• Certified Reference Materials/Calibrators: Solutions with known, traceable concentrations of Valproic Acid.

8. The Sample Size for the Training Set

No "training set" in the machine learning sense is described or applicable. This is a chemical assay, not an AI/ML algorithm. The assay's "design" is based on established biochemical principles (enzyme immunoassay).

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

Not applicable, as there is no training set in the context of an AI/ML algorithm. The "ground truth" for the development of such an assay would refer to the validation of its analytical characteristics using reference methods and certified calibrators, as mentioned in point 7.

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