Search Results

Valproic Acid (VPA) Reagent, in conjunction with the SYNCHRON® Systems Drug Calibrator 1 set, is intended for the quantitative determination of valproic acid concentration in human serum or plasma on SYNCHRON Systems.

Valproic Acid is an anticonvulsant drug. It is indicated for the treatment of absence (petite mal), generalized tonic-clinic and myoclonic seizures. Valproic Acid therapy is monitored for suspected inadequate dose or toxicity.

Valproic Acid Reagent is used to measure the valproic acid concentration by a particle enhanced turbidimetric inhibition immunoassay method.

The SYNCHRON Systems VPA Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4A/4PRO. CX5/5CE/5A/5PRO, CX7/7RTS/7Δ/7PRO, CX9ALX/9PRO) and SYNCHRON LX (LX20/PRO/LXi) Systems. The reagent kit contains two 100-test cartridges, and is packaged separately from the associated calibrators.

The provided document is a 510(k) premarket notification for a medical device: SYNCHRON® Systems Valproic Acid Reagent. This document is a regulatory submission to the FDA and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the level of detail regarding device performance studies, acceptance criteria, and ground truth establishment typically found in a research paper or a more comprehensive study report.

Based on the information provided, here's what can be extracted and what is explicitly not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states "updated performance claims (equivalency, precision) in the product inserts" and "Performance data from validation testing supports equivalency." However, it does not provide a specific table of acceptance criteria or detailed results of device performance against such criteria. It implies that these details would be found in the product inserts.

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

The document mentions "validation testing" but does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided. For clinical chemistry assays like valproic acid, "ground truth" is typically established by reference methods or validated laboratory measurements, not by expert consensus in the same way it would be for imaging diagnostics.

4. Adjudication Method for the Test Set:

This information is not applicable or provided. Adjudication methods are usually relevant for expert-based assessments, not for quantitative chemical assays where measurements are compared to reference standards.

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

MRMC studies are primarily relevant for diagnostic imaging interpretation or other scenarios involving human readers. This is a chemical reagent for a laboratory instrument, so an MRMC study is not applicable and therefore not mentioned.

6. Standalone Performance Study:

The document implies standalone performance testing as part of "validation testing" and updating "performance claims" (equivalency, precision). However, it does not detail the specifics of such a study, including its design or explicit results that would constitute "standalone performance." It primarily focuses on demonstrating equivalence to the previous version of the device rather than a ground-up standalone evaluation documented here.

7. Type of Ground Truth Used:

For this type of device (a quantitative reagent for valproic acid), the "ground truth" would typically be established by a reference method for valproic acid measurement, or by comparing results to a legally marketed predicate device (which is explicitly what this 510(k) references and compares against). The document states the modification "claims substantial equivalence to the Beckman Coulter SYNCHRON Systems VPA Reagent currently in commercial distribution, FDA 510(k) Number K961256." This comparison to a predicate device serves as the basis for establishing performance and "ground truth" in the context of a 510(k). No pathology or outcomes data is mentioned as ground truth.

8. Sample Size for the Training Set:

This information is not explicitly provided. For chemical reagents, "training sets" are not typically discussed in the same way as for machine learning algorithms. Instead, method development and optimization would involve various samples, but a specific "training set" size isn't usually reported in this context.

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

This information is not provided or applicable as "training set" ground truth in a machine learning sense. The "ground truth" for optimizing the reagent (if one were to call it a training phase) would involve comparing early formulations' results against a reference method or established values for known samples.

In summary:

This document is a regulatory submission focused on substantiating equivalence due to a modification of an already legally marketed device. It does not provide the detailed scientific study report typically associated with demonstrating performance against specific acceptance criteria for a novel device. The core of the submission is the "Comparison to the Predicate" based on an "ingredient change to the reagent formulation, optimization of the operating parameters on the LX instrument platform, and updated performance claims (equivalency, precision) in the product inserts." The study proving the device meets acceptance criteria is implied to be the "validation testing" that "supports equivalency," but the specifics of that testing are not included in this summary.

Table: Acceptance Criteria and Reported Device Performance (Based on available information)

Missing Information:

• Sample sizes for any testing.
• Data provenance (country, retrospective/prospective).
• Number and qualifications of experts for ground truth (not applicable for this device type).
• Adjudication method (not applicable for this device type).
• MRMC study (not applicable for this device type).
• Detailed standalone performance results (beyond a general statement of "equivalency" and "updated claims").
• Specific, quantifiable acceptance criteria for equivalency and precision.
• Details on ground truth establishment for "validation testing" samples (e.g., specific reference method used).
• Training set size and ground truth establishment (not explicitly applicable for this type of device development).

Ask a specific question about this device