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510(k) Data Aggregation
(469 days)
NWM
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay based on competition between drug in the specimen and lacosamide labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly related to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Lacosamide Assay consists of reagents R1 anti-lacosamide polyclonal antibody with substrate and R2 lacosamide labeled with bacterial G6PDH enzyme.
The provided text describes the ARK Lacosamide Assay, a homogeneous enzyme immunoassay for quantitative determination of lacosamide in human serum. This device is intended for monitoring lacosamide levels to ensure appropriate therapy. The substantial equivalence is demonstrated through comparative testing against a predicate device (ARKTM Topiramate Assay, K083799) and various performance characteristic studies.
Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LoQ) | Acceptable inter-assay precision (1.00 µg/mL) or ≤0.20 µg/mL (for ≤1.00 µg/mL) between 1st and 2nd order regressed values. | Linear relationship demonstrated between 0.40 and 25.00 µg/mL (y = 0.9998x - 0.0170). Differences within acceptable limits. |
| Precision (Total CV) | ≤10% total CV | For controls and human serum samples, total CVs ranged from 3.9% to 4.5%. |
| Interfering Substances | Measurement of lacosamide resulted in ≤10% error | All tested interfering substances resulted in ≤10% error (recoveries ranging from 95.8% to 103.5%). |
| Specificity (O-Desmethyl Metabolite) | Not clinically significant ( |
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(168 days)
NWM
The ARK™ Zonisamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of zonisamide in human serum or plasma samples on automated clinical chemistry analyzers. Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.
The ARK™ Zonisamide Calibrator is intended for use in calibration of the ARK Zonisamide Assay.
The ARK™ Zonisamide Control is intended for use in quality control of the ARK Zonisamide Assav.
The ARK Zonisamide Assay is a homogeneous immunoassay based on competition between drug in the specimen and zonisamide labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Zonisamide Assay consists of reagents R1 anti-zonisamide polyclonal antibody with substrate and R2 zonisamide labeled with bacterial G6PDH enzyme. The ARK Zonisamide Calibrator consists of a six-level set to calibrate the assay, and the ARK Zonisamide Control consists of a three-level set used for quality control of the assay.
Here's a breakdown of the acceptance criteria and the study details for the ARK Zonisamide Assay, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Test/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | 0.90) with predicate device | r² = 0.93 (0.91 to 0.95 95% CI) |
| Precision (Total CV) |
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(115 days)
NWM
The ARK™ Topiramate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers. The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
The ARK™ Topiramate Calibrator is intended for use in calibration of the ARK Topiramate Assav.
The ARKTM Topiramate Control is intended for use in quality control of the ARK Topiramate Assay.
The ARK Topiramate Assay is a homogeneous immunoassay based on competition between drug in the specimen and topiramate epitope labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for binding to the antibody reagent. As the latter binds antibody, enzyme activity decreases. In the presence of drug from the specimen, enzyme activity increases and is directly proportional to the drug concentration. Active enzyme converts the coenzyme nicotinamide adenine dinucleotide (NAD) to NADH that is measured spectrophotometrically as a rate of change in absorbance. Endogenous serum G6PDH does not interfere with the results because the coenyzme NAD functions only with the bacterial enzyme used in the assay.
The ARK Topiramate Assay consists of reagents R1 anti-topiramate polyclonal antibody with substrate and R2 topiramate epitope labeled with bacterial G6PDH enzyme. The ARK Topiramate Calibrator consists of a six-level set to calibrate the assay, and the ARK Topiramate Control consists of a three-level set used for quality control of the assay.
Here's a breakdown of the acceptance criteria and the studies that prove the device meets them, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | ≤20% CV with ±15% recovery | 1.5 µg/mL |
| Accuracy (Analytical Recovery) | Percent recoveries within 10% of theoretical levels | All reported values from 1.5 µg/mL to 55.0 µg/mL were within 10% of theoretical (e.g., 95.6% to 107.1% recovery). Example: 1.5 µg/mL recovered 95.6%, 55.0 µg/mL recovered 107.1%. |
| Linearity | Percent difference ≤ ±10% between predicted 1st and 2nd order regressed values | Demonstrated linearity between 1.2 and 54.0 µg/mL. Max % Difference outside this range was -18.14% at 0.6 µg/mL. All values within 1.2-54.0 µg/mL were within ±10%. |
| Assay Range | Not explicitly stated as acceptance criteria, but defined as output. | 1.5 µg/mL to 54.0 µg/mL |
| Precision (Total CV) |
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(70 days)
NWM
The Seradyn QMS® Topiramate assay is intended for the quantitative determination of topiramate in human serum or plasma on automated clinical chemistry analyzers.
The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy.
The Seradyn QMS® Topiramate assay is a homogeneous particle-enhanced turbidimetric immunoassay. The assay is based on competition between drug in the sample and drug coated onto a micronariticle for antibody binding sites of the topiramate antibody reagent. The topiramate-coated micropariticle peagent is rapidly agglutinated in the presence of the anti-topiramate antibody reagent and in the abserved of any competing drug in the sample. The rate of absorbance change is measured photometrically. When a smale containing topiramate is added, the agglutination reaction is partially inhibited, slowing down the rate of absorbance change. A concentration-dependent classic agglutination inhibition curve can be obtained with maximum rate of agglutination at the lowest topiramate concentration and the lowest agglutination rate at the highest topiramate concentration.
The assay consists of reagents R1: anti-topiramate polyclonal antibody and R2: topiramate-ooated microparticles. A six-level set of Seradyn QMS® Topiramate Cali three-level set of Seradyn QMS® Topiramate Controls is used for quality control of the assay.
Here's an analysis of the Seradyn QMS® Topiramate assay based on the provided 510(k) summary, structured to address your specific points:
Seradyn QMS® Topiramate Assay Study Analysis
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Recovery) | 100 ± 10% | Mean Percent Recovery: 104.6%. Individual recoveries ranged from 101.5% to 109.9%. All concentrations (3.20 to 32.00 µg/mL) met the acceptance criteria. |
| Linearity | Percent Difference: ±10% | All measured concentrations (1.5 to 35 µg/mL) showed a percent difference from the predicted result well within ±10% (ranging from -0.25% to 0.10%). |
| Sensitivity (LOQ) | ≤20% CV; recovery ± 15% | 1.5 µg/mL (Claimed in package insert). Specific data for LOQ meeting these criteria is not directly presented in the table, but the claim is based on observed acceptable inter-assay precision and recovery. |
| Assay Range | Based on Accuracy, Linearity, and Sensitivity (LOQ) | 1.5 to 32.0 µg/mL (Claimed reportable range). |
| Precision (Total CV) | 10% error: Ibuprofen, Phenytoin, Tiagabine. This implies the device does not meet the criteria for these specific drugs. | |
| Interferences (Anticoagulants) | No significant difference in recovery between serum and plasma samples | "No significant difference between the recovery of topiramate in serum or plasma. The collection tubes evaluated show no adverse effects on the recovery of topiramate." (Qualitative claim). |
| Calibration Curve Stability | N/A (implicit: stable for claimed period) | Supported for a period of 27 days. |
| Reagent On-Board Stability | N/A (implicit: stable for claimed period) | Supported for 60 days. |
| Method Comparison | Excellent correlation with predicate | N = 148, Slope = 0.962, y-intercept = 0.228, R² = 0.986. The report states: "Results show excellent correlation between the two assays." (Qualitative interpretation of quantitative results). |
2. Sample Size for the Test Set and Data Provenance:
- Accuracy: 12 concentrations for recovery study, each analyzed in triplicate (total of 36 measurements).
- Linearity: 9 concentrations, number of replicates not specified.
- Sensitivity (LOQ): Not specified directly, but implies multiple measurements around the LOQ value to determine CV and recovery.
- Precision: 3 controls, N=80 for each (total 240 measurements for precision components).
- Method Comparison: N = 148 patient samples.
- Interference (Endogenous & HAMA): Not explicitly stated, but for each interferent, samples with two known topiramate levels (approx. 5 and 20 µg/mL) were assayed.
- Interference (Co-Administered Drugs): Not explicitly stated, but for each compound, normal human serum with two known topiramate levels (approx. 5 and 20 µg/mL) was assayed.
- Interference (Anticoagulants): Not explicitly stated, but implied comparison of serum and plasma.
Data Provenance: The document does not specify the country of origin of the data. The studies are described as clinical testing, but it's common for these types of in vitro diagnostic studies to use banked or commercially sourced human serum/plasma samples, often without explicit geographical tags in 510(k) summaries. All studies appear to be prospective in the sense that they were designed experiments to evaluate the new device's performance against predefined criteria or a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This device is an in vitro diagnostic (IVD) assay for quantitative determination of a drug concentration. The "ground truth" here is the actual concentration of topiramate in the samples. This is typically established through:
- Reference materials: For linearity and accuracy by recovery, known concentrations are prepared by precise dilution of a high calibrator.
- Reference method/predicate device: For method comparison, the predicate Innofluor® Topiramate assay serves as the reference for comparison of patient sample results.
Therefore, no human experts were used to establish the "ground truth" in the way they would be for image analysis or disease diagnosis. The "ground truth" is defined by laboratory standards, precise dilutions, and the established performance of a reference or predicate method.
4. Adjudication Method for the Test Set:
Not applicable, as the ground truth is quantitative (actual concentration) and not based on human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging where multiple human readers interpret cases, and AI assistance might impact their performance. For a quantitative IVD assay, the performance is measured directly by analytical metrics (accuracy, precision, linearity, etc.) and comparison to a predicate device or reference method, not by human reader performance.
6. Standalone Performance:
Yes, the studies described (Accuracy, Linearity, Sensitivity, Precision, Specificity, Interferences, Stability) evaluate the algorithm's entire workflow (reagent interaction, measurement, and result calculation) standalone, without human-in-the-loop performance influencing the primary measurements. The assay quantifies topiramate concentration directly.
7. Type of Ground Truth Used:
- Known concentrations: For Accuracy by Recovery, Linearity, Sensitivity studies. These are prepared laboratory standards.
- Predicate device results: For Method Comparison, the results from the Seradyn Innofluor® Topiramate assay (K970510) on patient samples serve as the comparison point.
- Laboratory-spiked samples: For interference studies, known amounts of interferent and topiramate are added to serum samples.
8. Sample Size for the Training Set:
The document does not provide a sample size for a "training set." This assay is a homogeneous particle-enhanced turbidimetric immunoassay (PETIA), which is a chemical reaction-based method, not a machine learning or AI algorithm that typically requires a large "training set" of data in the common sense. The "development" or "optimization" of the assay would involve various experiments, but these are not usually referred to as a "training set" in the context of conventional IVD development. The calibration of the device uses a six-level set of Seradyn QMS® Topiramate Calibrators, but this is for operational calibration, not model training.
9. How the Ground Truth for the Training Set Was Established:
As noted above, the concept of a "training set" with established ground truth as in AI/ML is not directly applicable to this type of chemical immunoassay. The "ground truth" for calibrators and controls used in assay development and validation would be established through highly accurate reference methods, gravimetric/volumetric preparation, and traceability to established standards for the analyte (topiramate).
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(191 days)
NWM
The QMS Zonisamide assay is intended for the quantitative determination of zonisamide in human serum or plasma on automated clinical chemistry analyzers.
Zonisamide concentrations can be used as an aid in management of patients treated with zonisamide.
The QMS® Zonisamide Calibrator set is intended for use in calibration of the QMS Zonisamide assay.
The QMS® Zonisamide Control set is intended for use in quality control of the QMS Zonisamide assay.
The QMS Zonisamide assay system is a homogeneous assay utilizing particle agglutination technology and is based on the competitive binding principle.
The assay consists of reagents R1: anti-Zonisamide rabbit polyclonal antibody and R2: Zonisamidecoated microparticles. A six-level set of QMS® Zonisamide Calibrators (A through F) is used to calibrate the assay. A three-level set of QMS® Zonisamide Controls (1 through 3) is used for quality control of the assay.
The provided text describes the QMS® Zonisamide assay, a homogeneous particle-enhanced turbidimetric immunoassay for the quantitative determination of zonisamide in human serum or plasma. The information focuses on demonstrating its substantial equivalence to a legally marketed predicate device (Innofluor® Phenytoin) through performance testing.
Here's an analysis of the acceptance criteria and the studies performed, formatted as requested:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Study Goal | Reported Device Performance |
|---|---|---|
| Accuracy and Linearity | To evaluate the accuracy and linearity of the assay | Demonstrated accuracy and linearity based on NCCLS guideline EP6. |
| Sensitivity | Analytical Sensitivity (Least Detectable Dose - LDD) | 1.0 µg/mL |
| Functional Sensitivity (Limit of Quantitation - LOQ) | 3.0 µg/mL | |
| Assay Range | Reportable range for the assay | 3.0 to 50.0 µg/mL (Package insert claim based on Accuracy, Linearity, and Sensitivity data) |
| Method Comparison | Correlation with another method (implicit: to show agreement with a recognized method) | Correlation studies conducted using NCCLS Guideline EP9 (no specific correlation values provided in the summary). |
| Precision | To evaluate the precision performance of the assay | Precision study performed using NCCLS guideline EP5 (no specific precision values provided in the summary). |
| Specificity | No significant cross-reactivity with major metabolites (NAZ and SMAP) | No significant cross-reactivity for NAZ and SMAP. |
| Interferences | No significant cross-reactivity with common interfering substances/drugs | Of 26 drugs tested, none showed cross-reactivity. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes used for the test sets in the accuracy, linearity, method comparison, precision, specificity, or interference studies.
Regarding data provenance:
- The studies were conducted using well-established NCCLS guidelines, implying standardized laboratory testing.
- The method comparison used "patient samples," suggesting a clinical context, but no specifics about country of origin or whether it was retrospective or prospective are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are primarily analytical performance studies of a quantitative assay, where the "ground truth" for assay accuracy and calibration would typically be established by reference methods or gravimetric preparation of standards, not by human expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and therefore, not provided. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., image analysis, clinical diagnosis) where there might be inter-reader variability. For an automated quantitative assay, the "ground truth" is typically determined by objective reference methods or precise measurements, not by expert consensus adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve significant human interpretation (e.g., radiologists reading images) and the AI's impact on human performance. The QMS® Zonisamide assay is a quantitative determination assay performed on automated clinical chemistry analyzers, not an interpretive diagnostic tool requiring human readers in that sense.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are inherently standalone performance tests of the assay. The QMS® Zonisamide assay is a laboratory test system designed to provide quantitative results directly from automated analyzers. The reported performance metrics (accuracy, linearity, sensitivity, precision, specificity, interferences) evaluate the device's capability to accurately and reliably measure zonisamide concentrations without direct human interpretation influencing the measurement outcome.
7. The Type of Ground Truth Used
The ground truth for this type of quantitative assay would typically be established through:
- Reference Methods / Gravimetric Standards: For accuracy and linearity, highly precise and accurate reference methods or gravimetrically prepared standards with known zonisamide concentrations would be used.
- Known Concentrations: For sensitivity, specificity, and interference studies, samples with precisely known concentrations of zonisamide, metabolites, or interfering substances would be utilized.
- Patient Samples: For method comparison studies, the "ground truth" would be the results obtained from an established comparative method on actual patient samples.
The document does not explicitly detail the exact methods used for establishing ground truth for each study but implies standard laboratory practices using "patient samples" for method comparison and reference to NCCLS guidelines for other analytical performance.
8. The Sample Size for the Training Set
This information is not applicable and therefore, not provided. The QMS® Zonisamide assay is a biochemical immunoassay, not a machine learning or AI algorithm that requires a separate "training set" in the context of supervised learning. The assay's performance is driven by its reagent formulation, reaction kinetics, and instrument calibration, not by an algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an immunoassay. The chemical and biological principles of the assay itself, along with the manufacturing and quality control of the reagents and calibrators, establish its analytical performance capabilities.
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