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The ARCHITECT iValproic Acid assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of valproic acid, an anticonvulsant drug, in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used in monitoring levels of valproic acid to help ensure appropriate therapy.

The ARCHITECT iValproic Acid Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of valproic acid in human serum or plasma.

The ARCHITECT iValproic Acid assay is a one-step STAT immunoassay for the quantitative measurement of valproic acid in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antivalproic acid coated paramagnetic microparticles, and valproic acid acridiniumlabeled conjugate are combined to create a reaction mixture. The anti-valproic acid coated microparticles bind to valproic acid present in the sample and to the valoroic acid acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is mcasured as relative light units (RLUs). An indirect relationship exists between the amount of valproic acid in the sample and the RLUs detected by the ARCHITECT i System optics.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the ARCHITECT iValproic Acid assay:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size used for the clinical performance study (test set) or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions that clinical performance demonstrated substantial equivalency with a correlation coefficient of 0.986.

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

The provided text does not include information on experts, ground truth establishment, or their qualifications for the clinical performance study. This type of information is typically not required for an immunoassay 510(k) where the comparison is against an existing, legally marketed device. The "ground truth" in this context would likely be the measurements from the predicate device itself.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method. This is expected as the study is a comparison between two quantitative assays, not a study involving subjective interpretations that would require adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is a quantitative immunoassay meant for direct measurement, not an imaging device or diagnostic tool that involves human readers interpreting results in a comparative effectiveness setting. The study focused on the analytical performance of the new assay compared to a predicate device.

6. Standalone Performance

The clinical performance summary describes the standalone performance of the ARCHITECT iValproic Acid assay by demonstrating its correlation with the predicate AxSYM Valproic Acid assay. The correlation coefficient of 0.986 directly reflects the algorithm's (immunoassay's) performance in measuring valproic acid.

7. Type of Ground Truth Used

The "ground truth" for the clinical performance study was the measurements obtained from the legally marketed predicate device, the AxSYM Valproic Acid assay. The study aimed to show substantial equivalency of the new device's measurements to those of the predicate device.

8. Sample Size for the Training Set

The provided text does not specify a sample size for the training set. Immunoassay development typically involves extensive internal validation and optimization, but the regulatory submission focuses on the performance of the final assay.

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

The provided text does not detail how ground truth was established for a training set. For an immunoassay, training would involve optimizing reagents, protocols, and calibration curves using known concentrations or reference materials. The "ground truth" for these processes would be the expected or known concentrations of valproic acid in standards and controls used during development and calibration, rather than expert consensus on patient data.

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The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid in human serum or plasma on Roche automated clinical chemistry analyzers. Measurements muman serain of paintine were used in the diagnosis and treatement of valproic acid overdose and in monitoring the levels of valproic acid to help ensure appropriate therapy.

The ONLINE TDM Valproic Acid assay is for the quantitative determination of valproic acid in human serum or plasma on Roche automated clinical chemistry analyzers. The proposed labeling indicates the Roche Hitachi 911, 912, 917 and Modular P analyzers can be used with the Roche ONLINE TDM Valproic Acid reagent kits. The assay is based on a homogeneous enzyme immunoassay technique used for the quantitative analysis of valproic acid (free and protein-bound) in human serum or plasma. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the sample can be measured in terms of enzyme activity. Active enzyme converts oxidized nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that is measured spectrophotometrically. Endogenous serum G6PDH does not interfere because the coenzyme functions only with the bacterial (Leuconostoc mesenteroids) enzyme employed in the assay.

This submission describes the Roche ONLINE TDM Valproic Acid assay, an in-vitro diagnostic device. As such, the concept of "acceptance criteria" and "study" in the context of imaging devices or algorithms with human interpretation is not directly applicable in the same way.

Instead, for this device, the "acceptance criteria" are based on demonstrating substantial equivalence to a predicate device (Roche COBAS INTEGRA Valproic Acid, K951595) through performance characteristics typically evaluated for quantitative assays.

Here's an analysis based on the provided text, reinterpreting the questions for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this in-vitro diagnostic, "acceptance criteria" are implied by acceptable ranges for analytical performance characteristics that demonstrate substantial equivalence to the predicate. The study aimed to show that the new device's performance aligns with or is comparable to the predicate.

Note: The document doesn't explicitly state numerical acceptance criteria, but rather implies that the results should be "acceptable" and comparable to the predicate device to establish substantial equivalence. For precision, the values are compared directly. For method comparison, linearity, high correlation, and a near-zero intercept with a slope near one are generally expected.

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

• Precision Studies:
  • The sample size per control level for precision studies is not explicitly stated in the summary table. It only shows "Mean", "SD", and "CV%", which are derived from multiple measurements.
  • Data provenance is not specified (e.g., country of origin, retrospective/prospective).
• Method Comparison Study:
  • N=54 samples were used for the comparison between ONLINE TDM Valproic Acid and COBAS FP Valproic acid.
  • N=207 samples were used for the predicate comparison against COBAS FARA II (this is the predicate device's historical comparison, not the new device's).
  • Data provenance is not specified (e.g., country of origin, retrospective/prospective). The samples are human serum or plasma.

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

This type of information is not applicable for this device. For an in-vitro diagnostic assay that measures a chemical concentration, the "ground truth" is typically established by reference methods or highly accurate analytical techniques, not by expert consensus or interpretation of images. The comparison is made against the predicate device, which itself has an established accuracy.

4. Adjudication Method for the Test Set

This is not applicable for this type of in-vitro diagnostic device. Adjudication typically refers to resolving discrepancies between multiple human readers or between human readers and an AI, which is not relevant here.

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 is not applicable for this device. This assay is a standalone chemical measurement device, not an imaging device or an AI designed to assist human readers.

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

Yes, the studies presented are effectively standalone performance studies of the device (the "algorithm" being the assay's chemical reaction and detection system). The reported precision and method comparison data reflect the performance of the device itself, without human interpretation as part of the measurement outcome.

7. The Type of Ground Truth Used

The "ground truth" in this context is the measurement obtained from the predicate device (COBAS FP Valproic acid) or, indirectly, from a well-established reference method or a previously validated assay against which the predicate itself was compared (e.g., COBAS FARA II in the predicate's comparison). The goal is to show agreement with an already accepted method for quantifying valproic acid.

8. The Sample Size for the Training Set

This is not applicable as this is not a machine learning or AI-based device that requires a training set in the conventional sense. The "training" of the assay involves optimizing its chemical reagents and reaction conditions, which is part of the assay development process, not a data-driven training set for an algorithm.

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

This is not applicable as there is no "training set" for an algorithm in this context.

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This in vitro method is intended to quantitatively measure the antiepileptic drug valproic acid in human serum and plasma on the Bayer ADVIA® IMS systems. Measurements of valproic acid are used to aid in monitoring therapeutic levels of valproic acid to ensure appropriate therapy and in the treatment of valproic acid overdose.
The Bayer ADVIA IMS Valproic Acid method is for in vitro diagnostic use to measure the antiepileptic drug valproic acid in human serum and plasma. Measurements of valproic acid (2-propylpentanoic acid) are used as an aid in the diagnosis and treatment of valproic acid overdose, and in monitoring therapeutic levels of valproic acid to ensure appropriate therapy.

Not Found

1. Acceptance Criteria and Reported Device Performance

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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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The Roche ONLINE TDM Valproic Acid assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of valproic acid in human serum or plasma on automated clinical chemistry analyzers. Valproic acid is primarily used in the treatment of petit mal seizures and other generalized and partial complex seizures.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with valproic acid and rapidly aggregate in the presence of a valproic acid antibody solution. When a sample containing valproic acid is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formulation is inhibited. Thus, a classic inhibition curve with respect to valproic acid concentration is obtained, with the maximum rate of aggregation at the lowest valproic acid concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

The provided text describes the Roche ONLINE Valproic Acid Assay. Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section. However, the comparison to the predicate device and the discussion of "acceptable results" imply that performance characteristics aligning with or improving upon the predicate device's performance serve as the de facto acceptance criteria.

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

• Sample Size for Method Comparison:
  • N = 75 for comparison against Roche Valproic Acid II Assay.
  • N = 77 for comparison against Abbott TDx Valproic Acid Assay.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the document. The study involves comparing a new assay to existing predicate assays, which are themselves considered established methods for measuring valproic acid. Ground truth, in this context, is implicitly defined by the results of the predicate devices.

4. Adjudication Method for the Test Set:

This information is not provided in the document. Given the nature of a quantitative immunoassay comparison, typical adjudication methods used in image interpretation or diagnostic agreement studies (like 2+1 or 3+1) are not directly applicable. The "adjudication" is essentially the statistical comparison between the new assay's results and the predicate assay's results.

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 is not applicable to this device. The Roche ONLINE Valproic Acid Assay is an in vitro diagnostic reagent system for quantitative determination, not an AI-assisted diagnostic tool that aids human readers.

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

The device itself is a standalone assay (reagent system run on automated clinical chemistry analyzers); there is no "human-in-the-loop" performance in its direct function. The performance described (precision, method comparison) reflects the algorithm's (assay's) standalone accuracy and reproducibility.

7. The Type of Ground Truth Used:

The ground truth for the performance evaluation was the results obtained from the legally marketed predicate devices, specifically:

• Roche Valproic Acid II Assay (K930734)
• Abbott TDx Valproic Acid Assay

These predicate devices are assumed to provide accurate measurements of valproic acid.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device is a chemical immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the computational sense. The "development" of the assay would involve chemical formulation and optimization, not algorithmic training on data.

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

This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

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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).

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The SERADYN QMS™ / MULTIGENT™ VALPROIC ACID assay is used for the quantitation of valproic acid in human serum or plasma on the Abbott AEROSET® System. Valproic acid is a broad-spectrum anticonvulsant drug used solely or in combination with other anticonvulsant drugs for the treatment of absence seizures. It also has demonstrated effectiveness in the management of generalized tonic-clonic and myoclonic seizures, as well as atypical absence, simple and complex partial and mixed grand mal and petit mal seizures. The capability of treating many types of seizures with a single anticonvulsant has resulted in the wide-spread use of valproic acid, particularly in children in whom tonic-clonic and myclonic seizures are most prevalent. Valproic acid has proven effective in the treatment of many patients otherwise refractory to other anticonvulsant treatments. Most patients receiving valproic acid do not develop a tolerance to its anticonvulsant effects. Monitoring serum valproic acid levels combined with other clinical data can provide the physician with useful information to aid in adjusting patient dosage and achieving optimal therapeutic effect while avoiding useless sub-therapeutic or harmful toxic dosage levels.

The Seradyn QMS™ / MULTIGENT™ Valproic Acid Assay is a homogeneous Particle Enhanced Turbidimetric Immunoassay used for the quantitation of valproic acid in serum or plasma. The assay is intended for use on the Abbott AEROSET® System, using the Seradyn QMS™ / MULTIGENT™ Valproic Acid Calibrators. The reagent system components are 1) Valproic acid coated microparticle reagent, and 2) the antibody reagent which consists of a mouse monoclonal antibody specific for valproic acid. The technology is based on competition between the valproic acid in the sample and valproic acid coated onto the microparticles, for the antibody-binding sites of the anti-Valproic Acid antibody reagent. In the absence of valproic acid in the sample, the specific antibody in the antibody reagent binds the valoroic acid on the particle, and results in rapid agglutination of the microparticles. In the presence of valproic acid in the sample, the valproic acid in the sample competes for antibody binding sites of the specific antibody in the antibody reagent, and partially inhibits the agglutination of the microparticles. The rate of agglutination (turbidity) is directly proportional to the rate in absorbance change of incident light and is measured spectrophotometrically by the Abbott AEROSET® System at a wavelength of 604 nm. A six level Seradyn QMS™ / MULTIGENT™ Valproic Acid Calibrator set, with known valproic acid concentrations is used to quantitate the assay. An internal concentrationdependent calibration curve is generated by the AEROSET® System, by measuring the rate of absorbance change of each calibrator level. Maximum absorbance rate is at the lowest valproic acid concentration and the lowest absorbance rate at the highest valproic acid concentration. By monitoring the change in rate of a specimen with unknown valproic acid concentration, and comparing to the internal calibration curve, a sample's concentration can readily be obtained and reported as valproic acid concentration in either ug/mL or umol/L.

Here's a breakdown of the Seradyn QMS™/MULTIGENT™ Valproic Acid assay's acceptance criteria and the studies performed to demonstrate its performance:

1. Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance for Test Set

• Specificity (Cross-Reactivity): Each substance was tested in triplicate using control sera and spiked samples. The precise number of unique control sera or spiked samples is not specified beyond "control sera and spiked samples."
• Accuracy by Recovery: Tested at three different concentrations of valproic acid added to human serum. The number of samples for each concentration is not specified beyond "human serum."
• Sensitivity (Least Detectable Dose): Not explicitly stated, derived from statistical analysis of low concentration measurements.
• Accuracy & Linearity by Dilution: A 150.0 µg/mL VPA Calibrator was diluted to 80%, 60%, 20%, 10%, and 2.5%. Each diluted sample, as well as the undiluted calibrator, was analyzed in duplicate.
• Precision: A tri-level human serum-based commercial control was assayed in duplicate twice a day for twenty days. This means 80 measurements (3 levels * 2 duplicates/day * 20 days / 3 levels = 80 measurements per sample level).
• Method Comparison: 53 clinical specimens. Data provenance is not specified (e.g., country of origin, retrospective/prospective), but they are "clinical specimens," suggesting they are from real patients.
• Interfering Substances: For each interferent (bilirubin, hemoglobin, Intralipid), a human serum pool containing valproic acid was tested with and without the interferent. The interferent concentrations were tested twice (n=2 in the table).
• HAMA Interference: A normal human serum pool (control), and HAMA type 1 and HAMA type 2 samples were spiked with valproic acid. Each sample was assayed in duplicate.

Data Provenance: The studies appear to be laboratory-based analytical performance studies conducted by the device manufacturer (Seradyn, Inc.). The document does not specify countries of origin for samples or whether data was retrospective or prospective, but the nature of the tests suggests prospective analytical validation.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is an in-vitro diagnostic test for quantifying a chemical compound (valproic acid) in patient samples. The "ground truth" for the test set is established by known concentrations of valproic acid in controls, calibrators, or spiked samples, or by comparison to a legally marketed predicate device (Abbott AxSYM® Valproic Acid assay) which itself has established analytical accuracy. It does not involve human interpretation like in medical imaging.

4. Adjudication Method for Test Set

Not applicable for chemical assays. Ground truth is established by the known concentrations of calibrators, controls, or by direct comparison to a reference method or predicate device, not by expert consensus or adjudication.

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

Not applicable. This is an automated in-vitro diagnostic assay for quantitative measurement. It does not involve human readers interpreting cases or AI assistance in human interpretation.

6. Standalone (Algorithm Only) Performance

Yes, the studies reported are for the standalone analytical performance of the Seradyn QMS™/MULTIGENT™ Valproic Acid assay on the Abbott AEROSET® System. There is no human-in-the-loop performance described for this type of device.

7. Type of Ground Truth Used

The ground truth for the analytical validation studies was primarily established by:

• Known concentrations: For accuracy (recovery, linearity by dilution), precision, and sensitivity, valproic acid concentrations were either precisely known (e.g., calibrators, spiked samples).
• Comparison to a predicate device: For method comparison, the results were compared against the Abbott AxSYM® Valproic Acid assay, which is a legally marketed device cleared under K941615, establishing the "truth" for equivalency.

8. Sample Size for the Training Set

Not applicable. This device is an analytical assay, not an AI/ML model that undergoes a "training set" development phase in the conventional sense. Its performance is based on the inherent chemical and optical properties of the reagents and the instrument, which are developed and optimized through traditional analytical chemistry and engineering principles, not machine learning.

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

Not applicable, as there is no "training set" in the context of AI/ML for this type of chemical assay. The assay's "calibration" is performed using a six-level Seradyn QMS™/MULTIGENT™ Valproic Acid Calibrator set with known valproic acid concentrations. An internal concentration-dependent calibration curve is generated by the AEROSET System using these calibrators. This is standard practice for quantitative analytical assays.

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The Randox Laboratories Ltd. Valproic Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. inthunotational with valproic acid which, in the presence of valproic acid antibody solution, rapidly agglutinate. When a sample containing valproic acid is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of valproic acid in the sample. By aggraination the change in scattered light as a change in absorbance, a concentration curve can montoning the onling in absorbance is inversely proportional to the concentration of valbroic acid in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of valproic acid wse or overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers r noo must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

The Randox Laboratories Ltd. Valproic Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. inthunotational with valproic acid which, in the presence of valproic acid antibody solution, rapidly agglutinate. When a sample containing valproic acid is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of valproic acid in the sample. By aggraination the change in scattered light as a change in absorbance, a concentration curve can montoning the onling in absorbance is inversely proportional to the concentration of valbroic acid in the sample.

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance in the format you've outlined.

The document is an FDA 510(k) clearance letter for the Randox Valproic Acid Test Kit. It confirms that the device has been found substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Here's what I can extract and why I cannot complete most of your request:

What can be extracted:

• Device Name: Valproic Acid Test Kit
• Intended Use: "An in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. Measurements obtained by this device are used in the diagnosis and treatment of valproic acid use or overdose and in monitoring levels of valproic acid to ensure appropriate therapy."
• Mechanism of Action: Latex-enhanced immunoturbidimetric assay.

Why most of your request cannot be fulfilled from this document:

This 510(k) clearance letter does not include the actual study data, acceptance criteria, or performance data that were submitted by Randox Laboratories to the FDA. It is the FDA's response to that submission, stating that clearance has been granted.

Therefore, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics (e.g., accuracy, precision, linearity, limits of detection/quantification) or the acceptance criteria used for those metrics.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: An MRMC study is typically for imaging devices or those requiring human interpretation. This is an in-vitro diagnostic assay for a chemical measurement, so an MRMC study is highly unlikely to have been performed or relevant. The document does not mention it.
6. If a standalone performance (i.e. algorithm only without human-in-the loop performance) was done: As an in-vitro diagnostic kit, its performance is inherently standalone by the laboratory instrument, but the specific validation study details are not provided.
7. The type of ground truth used: Not mentioned. For an assay quantifying a substance, the "ground truth" would typically be established by a reference method (e.g., GC-MS) or highly accurate known concentrations.
8. The sample size for the training set: Not mentioned. (For an assay, "training set" might refer to data used during assay development and optimization, rather than a machine learning training set).
9. How the ground truth for the training set was established: Not mentioned.

To obtain the information you are looking for, you would typically need to review the actual 510(k) submission document or a summary thereof, which often includes the detailed study reports and performance data. This FDA clearance letter is merely the official notification of market clearance.

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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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