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1. For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System to quantitatively measure valproic acid (VALP) concentration in human serum and plasma. Serum or plasma valproic acid measurements are used in the diagnosis and treatment of valproic acid overdose and in monitoring levels of valproic acid to ensure appropriate therapy.
2. For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 12 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of valproic acid (VALP).
3. For in vitro diagnostic use only. VITROS TDM Performance Verifier is an assayed control used to monitor performance of ACET, CRBM, DGXN, PHBR, PHYT and VALP on VITROS Chemistry Systems.

The VITROS Chemistry Products VALP Reagent, VITROS Chemistry Products Calibrator Kit 12, and the VITROS Chemistry Products TDM Performance Verifiers are combined by the VITROS 5,1 FS Chemistry System to perform the VITROS VALP assay. VITROS Chemistry Products VALP Reagent is a dual chambered package containing ready-to-use liquid reagents that are used in a two-step reaction to quantitatively measure valproic acid.

VITROS Chemistry Products Calibrator Kit 12 and TDM Performance Verifiers are packaged and sold separately.

VITROS Chemistry Products Calibrator Kit 12 is a liquid ready to use calibrator set for valproic acid. Each kit contains one bottle each of six (6) levels. The level 1 bottle (zero level) contains 5 milliliters. The level 2 through 6 bottles each contain 2 milliliters.

VITROS Chemistry Products TDM Performance Verifier I, II and III are liquid ready to use controls with assaved values published for each lot. The controls are prepared from bovine serum with therapeutic drugs and preservatives added. The product is sold in separate kits of Level I, II and III. Each kit contains 6 vials (2 mL each).

Here's an analysis of the provided text regarding the acceptance criteria and study for the VITROS Chemistry Products VALP Assay.

It's important to note that this document is a 510(k) summary, which provides a high-level overview. Detailed performance data and acceptance criteria are typically found in the full 510(k) submission, not fully detailed in this summary.

Based on the provided text, the primary "acceptance criterion" for this device is substantial equivalence to a predicate device. This is a regulatory pathway for medical devices in the US, where a new device is deemed safe and effective if it can be shown to be at least as safe and effective as a legally marketed device (the predicate).

1. Table of Acceptance Criteria and Reported Device Performance

Note on Performance Verifiers: For the TDM Performance Verifiers, the acceptance criterion was "identical in intended use, base matrix, storage and handling and instructions for use" to previously cleared verifiers, with the only difference being the addition of valproic acid as a constituent.

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

• Sample Size: The document explicitly states "patient samples" were used for the correlation study to the predicate device. However, the specific number of patient samples is not provided in this 510(k) summary.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document refers to "patient samples," implying clinical samples. It is a retrospective analysis in the sense that the samples are collected and then tested with both the new device and the predicate device.

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

• Not Applicable (N/A) / Not Specified: For this type of chemical assay (quantitatively measuring a substance like valproic acid), "ground truth" is typically established by comparative measurement against a well-accepted, often reference standard, method or a legally marketed predicate device. The concept of "experts establishing ground truth" as it applies to subjective interpretations (e.g., radiologists reading images) is not directly relevant here. The predicate device itself serves as the benchmark.

4. Adjudication Method for the Test Set

• Not Applicable (N/A) / None: Adjudication methods like 2+1 or 3+1 are used for subjective assessments where multiple readers might disagree (e.g., medical image interpretation). For a quantitative chemical assay comparing results to a predicate device, such an adjudication method is not used. The comparison is direct and numerical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: An MRMC study is not relevant for this type of quantitative chemical assay. These studies are typically performed for devices that involve human interpretation of complex data (e.g., imaging devices) to assess the impact of AI on human reader performance. This device is an automated chemical analyzer.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, implicitly: This device is an automated in vitro diagnostic (IVD) assay designed to provide a quantitative result without human subjective interpretation influencing the measurement itself. The "algorithm" here is the chemical reaction and detection process performed by the VITROS 5,1 FS Chemistry System. The comparison study to the predicate device demonstrates its standalone performance. The results (concentration of valproic acid) are then used by clinicians for diagnosis and treatment.

7. The Type of Ground Truth Used

• Predicate Device Measurement / Commmercially Available Assay: The ground truth for evaluating the VITROS VALP assay was essentially the measurements obtained from the SYVA® Emit® 2000 Valproic Acid Assay, which is a legally marketed and established device (the predicate). The study established the relationship between the new device's readings and the predicate device's readings using patient samples. The term "ground truth" in this context refers to the accepted standard for measuring valproic acid.

8. The Sample Size for the Training Set

• Not applicable / Not specified: This document describes a traditional in vitro diagnostic device, not an AI/Machine Learning device that typically has a distinct "training set." The performance characteristics (precision, linearity, specificity, correlation) are established through analytical studies and clinical sample testing, not through an iterative machine learning training process with a dedicated training set. The development of such an assay involves extensive R&D and validation, but not in the "training set" sense common in AI.

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

• Not applicable / Not specified: As explained in point 8, the concept of a "training set" with established ground truth in the context of machine learning does not directly apply to this traditional IVD device. The "truth" in development would stem from reference methods, internal standards, and established analytical chemistry principles during assay design and optimization.

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