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510(k) Data Aggregation
(169 days)
OTF
The ARK™ Gabapentin Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of gabapentin in human serum or plasma on automated clinical chemistry analyzers. Gabapentin concentrations can be used as an aid in management of patients treated with gabapentin.
The ARKTM Gabapentin Calibrator is intended for use in calibration of the ARK Gabapentin Assay.
The ARKTM Gabapentin Control is intended for use in quality control of the ARK Gabapentin Assay.
The ARK Gabapentin Assay is a homogeneous immunoassay based on competition between drug in the specimen and gabapentin 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 Gabapentin Assay consists of reagents R1 anti-gabapentin polyclonal antibody with substrate and R2 gabapentin labeled with bacterial G6PDH enzyme. The ARK Gabapentin Calibrator consists of a six-level set to calibrate the assay, and the ARK Gabapentin Control consists of a three-level set used for quality control of the assay.
ARK Gabapentin products contain ≤0.09% sodium azide. As a precaution, affected plumbing should be flushed adequately with water to mitigate the potential accumulation of explosive metal azides. No special handling is required regarding other assay components.
Here's a summary of the acceptance criteria and study findings for the ARK™ Gabapentin Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Limit of Quantitation (LOQ) | ≤20% CV with ±15% recovery | 0.75 µg/mL (demonstrated acceptable inter-assay precision and recovery) |
| Recovery / Accuracy | Not explicitly stated as a defined criterion (implied by typical assay validation standards that recovery should be close to 100% within a certain range). | Mean percent recovery: 100.9% across concentrations from 1.0 to 40.0 µg/mL. |
| Linearity | Percent difference between predicted 1st and 2nd order regressed values of ±10%, or ±15% for concentrations ≤ 1.0 µg/mL. | Linear relationship demonstrated between 0.75 and 48.0 µg/mL. All points met the ±10% or ±15% (for lower concentrations) difference criteria. (e.g., 0.75 µg/mL: 12.0% difference; 1.0 µg/mL: 8.4% difference; all others below 2.2% difference up to 48 µg/mL). |
| Assay Range | Not explicitly stated as an acceptance criterion for the range itself, but the device performance defines the reportable range. | 0.75 to 40.0 µg/mL. |
| Method Comparison (Correlation) | Implied by the use of Passing-Bablok regression: a slope close to 1, y-intercept close to 0, and a high correlation coefficient (r²) indicating strong agreement with reference methods. | Study 1 (LC-MS/MS): Slope 0.96 (0.92 to 0.99), y-intercept -0.06 (-0.28 to 0.18), r² 0.96 (0.95 to 0.97). |
| Study 2 (HPLC): Slope 1.08 (1.03 to 1.13), y-intercept -0.08 (-0.35 to 0.25), r² 0.97 (0.95 to 0.98). | ||
| Study 3 (LC-MS/MS): Slope 1.13 (1.08 to 1.17), y-intercept 0.31 (0.06 to 0.52), r² 0.98 (0.97 to 0.99). | ||
| Precision |
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