(169 days)
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No
The device description and performance studies detail a standard enzyme immunoassay for quantitative determination of gabapentin. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance metrics.
No.
This device is an immunoassay intended for the quantitative determination of gabapentin levels in human serum or plasma to aid in the management of patients treated with gabapentin. It is a diagnostic test, not a therapeutic device that provides treatment.
Yes.
The device is intended for the quantitative determination of gabapentin in human serum or plasma to aid in the management of patients treated with gabapentin, which is a diagnostic purpose.
No
The device is a homogeneous enzyme immunoassay, which involves chemical reagents and reactions to measure gabapentin levels. This is a laboratory assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of gabapentin in human serum or plasma". This involves testing biological specimens (serum or plasma) outside of the body (in vitro).
- Purpose: The results are used "as an aid in management of patients treated with gabapentin". This indicates a medical purpose related to patient care.
- Device Description: The description details a "homogeneous enzyme immunoassay" which is a common type of in vitro diagnostic test. It also describes reagents, calibrators, and controls, which are typical components of IVD kits.
- Performance Studies: The document includes performance studies like Limit of Quantitation, Recovery, Linearity, Method Comparison, and Precision, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a predicate device (K083799; ARKTM Topiramate Assay) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the 510(k) submission process for IVDs.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OTF, DLJ, LAS
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Routine clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Limit of Quantitation (LOQ): The LOQ was determined to be 0.75 ug/mL.
Recovery: Accuracy (analytical recovery) was performed by adding concentrated gabapentin drug into human serum negative for gabapentin. The mean percent recovery was 100.9%.
Linearity: A linear relationship was demonstrated between 0.75 and 48.0 µg/mL.
Assay Range: The range of the assay is 0.75 to 40.0 µg/mL.
Method Comparison:
- Study 1: Comparison with LC-MS/MS. Number of Samples: 183. Slope: 0.96 (0.92 to 0.99). y-intercept: -0.06 (-0.28 to 0.18). Correlation Coefficient (r2): 0.96 (0.95 to 0.97).
- Study 2: Comparison with HPLC. Number of Samples: 64. Slope: 1.08 (1.03 to 1.13). y-intercept: -0.08 (-0.35 to 0.25). Correlation Coefficient (r2): 0.97 (0.95 to 0.98).
- Study 3: Comparison with LC-MS/MS. Number of Samples: 49. Slope: 1.13 (1.08 to 1.17). y-intercept: 0.31 (0.06 to 0.52). Correlation Coefficient (r2): 0.98 (0.97 to 0.99).
Precision: Determined using CLSI/NCCLS Protocol EPS-A2. Each level was assayed in quadruplicate twice a day for 20 days (N=160 for each). Acceptance criteria:
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.
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510(k) SUMMARY
NOV 2 3 2010
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K101574.
| 807.92 (a)(1): Name: | ARK Diagnostics, Inc. | ||
|---|---|---|---|
| Address: | 1190 Bordeaux Drive | ||
| Sunnyvale, CA 94089 | |||
| Owner Operator Number: | 10027663 | Establishment Registration: | 3005755244 |
| Phone: | (408) 747-0700 | ||
| FAX: | (408) 747-0783 | ||
| Contact: | Kenneth C. Kasper, PhD – (408) 747-0708 | ||
| Executive Director of Quality and Regulatory Affairs |
Date prepared: November 23, 2010
807.92 (a)(2): Device name- trade name and common name, and classification
| Trade name: | ARKTM Gabapentin Assay
ARKTM Gabapentin Calibrator
ARKTM Gabapentin Control |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Common Name: | Homogeneous Enzyme Immunoassay |
| Classification: | 21 CFR 862.3350 NWM Diphenylhydantoin Test System; Class II
(21 CFR 862.3200 DLJ, 21 CFR 862.3280 LAS) |
807.92 (a)(3): Identification of the legally marketed predicate device
ARKTM Topiramate Assay ARK™ Topiramate Calibrator ARK™ Topiramate Control
K083799 (bundled)
Image /page/0/Picture/11 description: The image contains a black circle on a white background. The circle is located on the left side of the image. The circle is solid black and has a smooth edge. The rest of the image is white.
ARK Diagnostics, Inc. - 510(k) Summary ARK Gabapentin Assay
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807.92 (a)(4): Device Description
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.
807.92 (a)(5): Intended Use / Indications for Use
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.
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807.92 (a)(6): Technological Similarities and Differences to the Predicate
SUBSTANTIAL EQUIVALENCE COMPARATIVE CHART
| Characteristic | Device | Predicate |
|---|---|---|
| ARK™ Gabapentin Assay | ARK™ Topiramate Assay K083799 | |
| Intended Use | The ARK™ Gabapentin Assay is intended | |
| for the quantitative determination of | ||
| gabapentin in human serum or plasma on | ||
| automated clinical chemistry analyzers. | The ARK™ Topiramate Assay is intended | |
| for the quantitative determination of | ||
| topiramate in human serum or plasma on | ||
| automated clinical chemistry analyzers. | ||
| Indications for Use | Gabapentin concentrations can be used as an | |
| aid in management of patients treated with | ||
| gabapentin. | The results obtained are used in the diagnosis | |
| and treatment of topiramate overdose and in | ||
| monitoring levels of topiramate to help | ||
| ensure appropriate therapy. | ||
| Sample | Serum or plasma | Serum or plasma |
| Methodology | Homogenous enzyme immunoassay (EIA) | Homogenous enzyme immunoassay (EIA) |
| Reagent Components | Two (2) reagent system: | Two (2) reagent system: |
| Anti- gabapentin Antibody/Substrate | ||
| Reagent (R1) containing rabbit polyclonal | ||
| antibodies to gabapentin, glucose-6- | ||
| phosphate, nicotinamide adenine | ||
| dinucleotide, bovine serum albumin, sodium | ||
| azide, and stabilizers | Anti-topiramate Antibody/Substrate Reagent | |
| (R1) containing rabbit polyclonal antibodies | ||
| to an epitope of topiramate, glucose-6- | ||
| phosphate, nicotinamide adenine | ||
| dinucleotide, bovine serum albumin, | ||
| preservatives, and stabilizers | ||
| Enzyme Reagent (R2) containing gabapentin | ||
| labeled with bacterial G6PDH, buffer, bovine | ||
| serum albumin, sodium azide, and stabilizers | Enzyme Reagent (R2) containing topiramate | |
| epitope labeled with bacterial G6PDH, | ||
| buffer, bovine serum albumin, preservatives, | ||
| and stabilizers | ||
| Platform required | Automated clinical chemistry analyzer | Automated clinical chemistry analyzer |
| Accessory reagents | Calibrators (six levels) and controls (three | |
| levels) | Calibrators (six levels) and controls (three | |
| levels) | ||
| Testing | ||
| environment | Routine clinical laboratory | Routine clinical laboratory |
| Reagent condition | ||
| and storage | Liquid, 2-8° C | Liquid, 2-8° C |
Comparison between the ARK™ Gabapentin Assay and the ARK™ Topiramate Assay
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ARK Diagnostics, Inc. - 510(k) Summary ARK Gabapentin Assay
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807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data
Limit of Quantitation (LOQ)
The LOQ of the ARK Gabapentin Assay was determined according to CLSI EP17-A and is defined as the lowest concentration for which acceptable inter-assay precision and recovery is observed (≤20% CV with ±15% recovery). The LOQ was determined to be 0.75 ug/mL.
Recovery
Accuracy (analytical recovery) was performed by adding concentrated gabapentin drug into human serum negative for gabapentin. A stock concentrate of highly pure gabapentin was added volumetrically to human serum negative for gabapentin, representing drug concentrations across the assay range. Six replicates of each sample were assayed on an automated clinical chemistry analyzer. The results were averaged and compared to the target concentration and percent recovery calculated. Results are shown below.
| % Recovery = 100 X Mean recovered concentration | |
|---|---|
| Theoretical concentration |
| Theoretical
Concentration
(µg/mL) | Mean Recovered
Concentration
(µg/mL) | Percent
Recovery |
|-----------------------------------------|--------------------------------------------|---------------------|
| 1.0 | 0.99 | 98.5 |
| 2.0 | 2.07 | 103.3 |
| 3.5 | 3.55 | 101.3 |
| 9.0 | 8.98 | 99.7 |
| 16.0 | 16.03 | 100.2 |
| 22.0 | 22.00 | 100.0 |
| 28.0 | 27.85 | 99.5 |
| 35.0 | 35.59 | 101.7 |
| 40.0 | 41.49 | 103.7 |
Mean percent recovery: 100.9%
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Linearitv
Linearity studies were performed as suggested in CLSI/NCCLS Protocol EP6-A. A 48.0 µg/mL serum sample was prepared and dilutions were made proportionally with human serum negative for gabapentin. Gabapentin concentrations ranged from 0.75 to 48.0 µg/mL. Linearity at specific dilutions was considered acceptable if the percent difference was ±10% between the predicted 1st and 2nd order regressed values or ±15% ≤ 1.0 µg/mL. A linear relationship was demonstrated between 0.75 and 48.0 µg/mL. Results are shown below.
| Theoretical
(µg/mL) | Results
(ug/mL) | 1st Order
Predicted
Results | 2nd Order
Predicted
Results | % Difference |
|------------------------|--------------------|-----------------------------------|-----------------------------------|--------------|
| 0.75 | 0.73 | 0.76 | 0.85 | 12.0 |
| 1.0 | 1.0 | 1.0 | 1.1 | 8.4 |
| 2.4 | 2.4 | 2.4 | 2.4 | 2.2 |
| 3.2 | 3.3 | 3.2 | 3.2 | 1.1 |
| 4.8 | 4.9 | 4.8 | 4.8 | 0.0 |
| 8.0 | 8.0 | 8.0 | 7.9 | -0.7 |
| 12.0 | 11.9 | 12.0 | 11.9 | -0.9 |
| 24.0 | 23.6 | 23.9 | 23.8 | -0.6 |
| 32.0 | 31.8 | 31.9 | 31.8 | -0.3 |
| 40.0 | 39.7 | 39.8 | 39.9 | 0.2 |
| 48.0* | 48.1 | 47.8 | 48.1 | 0.6 |
*Concentration exceeds the reportable limit.
Assay Range
The range of the assay is 0.75 to 40.0 µg/mL. Report results below this range as 40.0 µg/mL or above the analyzer-specific upper LOQ established in your laboratory.
Specimens testing initially above the assay range may be diluted in Calibrator A and retested. Multiply the assay result by the dilution factor to obtain the concentration of gabapentin in the undiluted specimen. A dilution factor of 4 is suggested.
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Method Comparison
Correlation studies were performed using CLSI/NCCLS Protocol EP9-A2. Results from the ARK Gabapentin Assay were compared with results from three study sites using high performance liquid chromatography - mass spectrometry methods (LC-MS/MS, Study 1), HPLC (Study 2) and LC-MS/MS (Study 3).
Study 1
Gabapentin concentrations by LC-MS/MS ranged 1.0 to 39.0 µg/mL. ARK gabapentin values ranged 0.6 to 34.4 ug/mL Results of the Passing-Bablok23 regression analysis for the study are shown below (with 95% confidence limits).
| Slope | 0.96 | (0.92 to 0.99) |
|---|---|---|
| y-intercept | - 0.06 | (-0.28 to 0.18) |
| Correlation Coefficient (r2) | 0.96 | (0.95 to 0.97) |
| Number of Samples | 183 |
Image /page/5/Figure/5 description: This image is a scatter plot comparing two different methods of measuring Gabapentin levels. The x-axis represents the LC-MS/MS method, while the y-axis represents the ARK Gabapentin Assay, both measured in micrograms per milliliter. The plot includes two lines: one representing the identity line and another representing the Passing & Bablok fit, with the equation (-0.06 + 0.96x).
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Study 2
Gabapentin concentrations by HPLC ranged from 1.8 to 29.4 µg/mL. ARK gabapentin values ranged 1.6 to 32.6 µg/mL. Results of the Passing-Bablok35 regression analysis for the study are shown below (with 95% confidence limits).
| Slope | 1.08 | (1.03 to 1.13) |
|---|---|---|
| y-intercept | -0.08 | (-0.35 to 0.25) |
| Correlation Coefficient ( $r^2$ ) | 0.97 | (0.95 to 0.98) |
| Number of Samples | 64 |
Image /page/6/Figure/3 description: The image is a scatter plot comparing two different assays for Gabapentin. The x-axis represents the results from Study 2: HPLC (µg/mL), while the y-axis represents the results from the ARK Gabapentin Assay (µg/mL). The plot includes a line of identity and a Passing & Bablok fit line, with the equation (-0.08 + 1.08x) displayed. The data points are clustered around the lines, indicating a correlation between the two assays.
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Study 3
Gabapentin concentrations by LC-MS/MS ranged 1.4 to 29.6 µg/mL. ARK gabapentin values ranged 1.6 to 32.6 µg/mL. Results of the Passing-Bablok25 regression analysis for the study are shown below (with 95% confidence limits).
| Slope | 1.13 | (1.08 to 1.17) |
|---|---|---|
| y-intercept | 0.31 | (0.06 to 0.52) |
| Correlation Coefficient (r²) | 0.98 | (0.97 to 0.99) |
| Number of Samples | 49 |
Image /page/7/Figure/3 description: This image is a scatter plot comparing two different assays for Gabapentin. The x-axis represents the LC-MS/MS assay in micrograms per milliliter, while the y-axis represents the ARK Gabapentin Assay, also in micrograms per milliliter. The plot includes a line of identity and a Passing & Bablok fit line, which is represented by the equation y = 0.31 + 1.13x. The data points are clustered around the lines, indicating a correlation between the two assays.
Image /page/7/Picture/4 description: The image shows a black circle in the upper left corner. Below the circle, the text "ARK Diagnos" is visible. The text is in a simple, sans-serif font and appears to be part of a larger document or logo.
ARK Diagnostics, Inc. – 510(k) Summary ARK Gabapentin Assay
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Precision
Precision was determined as described in CLSI/NCCLS Protocol EPS-A2. Tri-level controls and three human serum pooled specimens containing gabapentin were used in the study. Each level was assayed in quadruplicate twice a day for 20 days. Each of the runs per day was separated by at least two hours. The within run, between day, total SD, and percent CVs were calculated. Results are shown below. Acceptance criteria: