Search Results

This in vitro method is intended to quantitatively measure valproic acid, an anticonvulsant drug, in human serum or plasma (heparin) using Syva EMIT Valproic Acid Assay on a Technicon Immuno-1 system. Measurements of valproic acid are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

Not Found

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

K964442 Valproic Acid Method for Bayer Technicon Immuno 1 System

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided information, the acceptance criteria are implicitly defined by the performance of the predicate device (Syva EMIT® Valproic Acid Assay) and the demonstration of equivalent or better performance by the Immuno 1 Valproic Acid method.

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

• Sample Size for Test Set: 50
• Data Provenance: Not specified, but the study compares the Immuno 1 method with the Syva EMIT® Valproic Acid Assay using a COBAS FARA II Instrument. The source of the human serum or plasma samples is not mentioned (e.g., country of origin). The study appears to be a prospective comparison study conducted by Bayer Corporation.

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

This type of device (in vitro diagnostic for drug measurement) does not typically rely on human expert interpretation for ground truth. The "ground truth" in this context is the measurement obtained from a recognized, established, and previously cleared method (the predicate device). Therefore, this question is not applicable to this study.

4. Adjudication Method for the Test Set

This question is not applicable as the comparison is between two analytical methods, not involving human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable. This is an in vitro diagnostic device for quantitative measurement of a drug, not an image-based or interpretation-based AI system that would involve human readers.

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

Yes, the study describes the standalone performance of the Immuno 1 Valproic Acid method by comparing its measurements to those of the predicate device. There is no human-in-the-loop component for the measurement itself, as it is an automated assay.

7. The Type of Ground Truth Used

The "ground truth" in this study is the measurements obtained from the predicate device, the Syva EMIT® Valproic Acid Assay, performed on a COBAS FARA II Instrument. The immunoassay results from the predicate serve as the reference standard against which the new device's performance is compared for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not provided in the summary. For an in vitro diagnostic device like this, there isn't a "training set" in the same sense as machine learning models. Instead, methods are developed and validated through a series of experiments. The presented data is likely from a validation study.

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

Since a "training set" in the machine learning sense is not explicitly mentioned or applicable, the method for establishing its ground truth is not provided. If an analytical method development phase involved internal optimization, the "ground truth" would have likely been established through reference materials, spiked samples, or comparison to established gold-standard analytical methods (e.g., GC-MS or HPLC), but this detail is not in the provided document. The current submission focuses on the performance comparison for substantial equivalence.

Ask a specific question about this device