(115 days)
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No
The device description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML techniques. The performance studies focus on standard analytical validation methods for quantitative assays.
No.
This device is an in vitro diagnostic (IVD) assay designed to measure topiramate levels in human serum or plasma. It is used to monitor drug levels and in the diagnosis/treatment of topiramate overdose, which supports therapeutic decisions rather than directly providing therapy.
Yes
The text explicitly states under "Intended Use / Indications for Use" that "The results obtained are used in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy." This indicates its role in diagnosing a medical condition (topiramate overdose).
No
The device is a homogeneous enzyme immunoassay, which is a laboratory test kit consisting of chemical reagents (R1 and R2), calibrators, and controls. These are physical components used in a clinical chemistry analyzer, not software.
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 topiramate in human serum or plasma." This involves testing biological specimens (serum or plasma) outside of the body (in vitro).
- Purpose: The results are used "in the diagnosis and treatment of topiramate overdose and in monitoring levels of topiramate to help ensure appropriate therapy." This directly relates to providing information for medical diagnosis and treatment decisions.
- Device Description: The description details a "homogeneous enzyme immunoassay," which is a common type of in vitro diagnostic test.
- Components: The device includes "reagents," "calibrator," and "control," which are standard components of IVD kits used for performing tests and ensuring accuracy.
- Performance Studies: The document includes performance studies like "Accuracy," "Linearity," "Method Comparison," and "Precision," which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device(s): The mention of predicate devices with K numbers (K070645, K970509, K970517) indicates that this device is being compared to previously cleared IVD devices.
All of these factors strongly indicate that the ARK™ Topiramate Assay, Calibrator, and Control are intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
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.
Product codes
NWM, DLJ, LAS
Device Description
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.
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
Not Found
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
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Summary of Performance Studies
Nonclinical testing:
Limit of Quantitation (LOQ): The LOQ of the ARK Topiramate 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 (often considered ≤20% CV with ±15% recovery). The LOQ was determined to be 1.5 ug/mL.
Accuracy (analytical recovery): Performed by adding concentrated topiramate drug into human serum negative for topiramate across the assay range. Six replicates of each sample were assayed on an automated clinical chemistry analyzer. Percent recoveries from the testing (in six replicates) of samples spiked between 1.5 and 55.0 µg/mL were all within 10% of their theoretical levels.
Linearity: Linearity studies were performed as suggested in CLSI/NCCLS Protocol EP6-A. A 60.0 µg/mL serum sample was prepared and dilutions were made proportionally with human serum negative for topiramate. Topiramate concentrations ranged from 0.6 to 60.0 ug/mL. Linearity at specific dilutions was considered acceptable if the percent difference was ±10% between the predicted 158 and 2nd order regressed values. A linear relationship was demonstrated between 1.2 and 54.0 ug/mL.
Assay Range: The range of the assay is 1.5 to 54.0 ug/mL.
Method Comparison: Correlation studies were performed using CLSI/NCCLS Protocol EP9-A2. Results (113 samples, range 1.5 µg/mL to 53.4 µg/mL) from the ARK Topiramate assay were compared with results from a commercially available FPIA Immunoassay. Passing-Bablok regression analysis showed a slope of 0.99, y-intercept of -0.17, and correlation coefficient (r²) of 0.99.
Precision: Determined as described in CLSI/NCCLS Protocol EP5-A2. Tri-level controls containing topiramate were used. Each level of control was assayed in quadruplicate twice a day for 20 days (N=160). Acceptance criteria was
§ 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.
0
510(k) SUMMARY
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 K083799.
ARK Diagnostics, Inc. 807.92 (a)(1): Name:
1190 Bordeaux Drive Address: Sunnyvale, CA 94089
Owner Operator Number: 10027663
| 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: April 14, 2009
807.92 (a)(2): Device name- trade name and common name, and classification
| Trade name: | ARKTM Topiramate Assay
ARKTM Topiramate Calibrator
ARKTM Topiramate 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
| Seradyn QMS® Topiramate Assay | K070645 |
|---|---|
| Seradyn QMS® Topiramate Calibrator | K970509 INNOFLUOR |
| Seradyn QMS® Topiramate Control | K970517 INNOFLUOR |
1
807.92 (a)(4): Device Description
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.
807.92 (a)(5): Intended Use / Indications for Use
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.
2
807.92 (a)(6): Technological Similarities and Differences to the Predicate
SUBSTANTIAL EQUIVALENCE COMPARATIVE CHART
| Characteristic | Device | Predicate |
|---|---|---|
| Intended Use | ARK™ Topiramate Assay | |
| The ARK™ Topiramate Assay is intended | ||
| for the quantitative determination of | ||
| topiramate in human serum or plasma on | ||
| automated clinical chemistry analyzers. | Seradyn QMS® Topiramate K070645 | |
| The Seradyn QMS® Topiramate Assay is | ||
| intended for the quantitative determination of | ||
| topiramate in human serum or plasma on | ||
| automated clinical chemistry analyzers. | ||
| Indications for Use | 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 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 particle-enhanced |
| turbidometric immunoassay (particle | ||
| agglutination) (PETIA) | ||
| Reagent | ||
| Components | Two (2) reagent system: | |
| Anti-topiramate Antibody/Substrate Reagent | ||
| (R1) containing rabbit polyclonal antibodies | ||
| to topiramate, glucose-6-phosphate, | ||
| nicotinamide adenine dinucleotide, bovine | ||
| serum albumin, preservatives, and stabilizers |
Enzyme Reagent (R2) containing topiramate
epitope labeled with bacterial G6PDH,
buffer, bovine serum albumin, preservatives,
and stabilizers | Two (2) reagent system:
Anti-topiramate Antibody Reagent (R1) in
buffers containing protein stabilizers with
sodium azide
Topiramate-coated Microparticle Reagent
(R2) in buffer containing surfactant as
stabilizers with sodium azide |
| Platform required | Automated clinical chemistry analyzer | Automated clinical chemistry analyzer |
| Accessory reagents | Calibrators (six levels) 0.0 to 60.0 µg/mL
and controls (three levels) | Calibrators (six levels) 0.0 to 32.0 µg/mL
and controls (three levels) |
| Testing
environment | Routine clinical laboratory | Routine clinical laboratory |
| Reagent condition
and storage | Liquid, 2-8° C | Liquid, 2-8° C |
| Assay Range | 1.5 µg/mL to 54.0 µg/mL | 1.5 µg/mL to 32.0 µg/mL |
| Total Precision
(each sample tested
4x/day or 8x/day
for 20 days) | Sample 1
N 160
mean 2.4
SD 0.10
%CV 4.3
Sample 2
N 160
mean 10.2
SD 0.28
%CV 2.7 | Sample 1
N 80
mean 2.94
SD 0.12
%CV 4.22
Sample 2
N 80
mean 10.14
SD 0.34
%CV 3.37 |
| Characteristic | Device | Predicate |
| | ARK™ Topiramate Assay | Seradyn QMS® Topiramate K070645 |
| Accuracy-recovery | Percent recoveries from the testing (in six
replicates) of samples spiked between 1.5
and 55.0 µg/mL were all within 10% of their
theoretical levels | Percent recoveries from the testing (in
triplicate) of samples spiked between 1.28
and 32.00 µg/mL were all within 10% of
their theoretical levels |
| Method
Comparison (each
assay compared to
a commercially-
available FPIA
immunoassay | No of samples: 113
Range of samples: 1.5 µg/mL to 53.4 µg/mL
Slope: 0.99
y-intercept: - 0.17
correlation coefficient (r²): 0.99 | No of samples: 148
Range of samples: 1.56 µg/mL to 30.72 µg/mL
Slope: 0.962
y-intercept: 0.228
correlation coefficient (r²): 0.986 |
| Interfering
substances | A series of biological substances and co-
administered drugs were tested for potential
interference at two levels (approx. 5 and 20
µg/mL) of topiramate. The results
demonstrated a ≤ 10% difference between
the control samples and the challenged
samples. | A series of biological substances and co-
administered drugs were tested for potential
interference at two levels (approx. 5 and 20
µg/mL) of topiramate. The results
demonstrated a ≤ 10% difference between
the control samples and the challenged
samples. |
Comparison between the ARK™ Topiramate Assay and the Seradyn QMS® Topiramate Assay
ARK Diagnostics, Inc. -- 510(k) Summary, Rev. 4
3
807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data
Limit of Quantitation (LOQ)
The LOO of the ARK Topiramate 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 (often considered ≤20% CV with ±15% recovery). The LOQ was determined to be 1.5 ug/mL.
Accuracy
Accuracy (analytical recovery) was performed by adding concentrated topiramate drug into human serum negative for topiramate. A stock concentrate of highly pure topiramate was added volumetrically to human serum negative for topiramate, 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
4
| Theoretical
Concentration
(µg/mL) | Mean Recovered
Concentration
(µg/mL) | Percent
Recovery |
|-----------------------------------------|--------------------------------------------|---------------------|
| 1.5 | 1.4 | 95.6 |
| 2.0 | 2.7 | 106.7 |
| 4.0 | 4.2 | 104.2 |
| 5.0 | 5.3 | 106.0 |
| 6.0 | 6.4 | 106.7 |
| 10.0 | 10.4 | 103.8 |
| 15.0 | 15.5 | 103.4 |
| 30.0 | 30.8 | 102.6 |
| 45.0 | 47.3 | 105.0 |
| 55.0 | 58.9 | 107.1 |
Linearity
Linearity studies were performed as suggested in CLSI/NCCLS Protocol EP6-A. A 60.0 µg/mL serum sample was prepared and dilutions were made proportionally with human serum negative for topiramate. Topiramate concentrations ranged from 0.6 to 60.0 ug/mL. Linearity at specific dilutions was considered acceptable if the percent difference was ±10% between the predicted 158 and 2nd order regressed values. A linear relationship was demonstrated between 1.2 and 54.0 ug/mL. Results are shown below.
| Estimated Value
(µg/mL) | Results
(µg/mL) | 1st Order
Predicted
Results | 2nd Order
Predicted
Results | % Difference
(Acceptance
Criteria: ±10%) |
|----------------------------|--------------------|-----------------------------------|-----------------------------------|------------------------------------------------|
| 0.6 | 0.5 | 0.56 | 0.46 | -18.14 |
| 1.2 | 1.0 | 1.19 | 1.10 | -7.42 |
| 1.8 | 1.7 | 1.83 | 1.75 | -4.16 |
| 2.4 | 2.4 | 2.46 | 2.40 | -2.60 |
| 3.0 | 3.0 | 3.09 | 3.04 | -1.68 |
| 3.6 | 3.7 | 3.73 | 3.69 | -1.09 |
| 4.2 | 4.4 | 4.36 | 4.33 | -0.68 |
| 4.8 | 4.9 | 4.99 | 4.98 | -0.38 |
| 5.4 | 5.8 | 5.63 | 5.62 | -0.15 |
| 6.0 | 6.3 | 6.26 | 6.26 | 0.02 |
| 12.0 | 12.9 | 12.60 | 12.68 | 0.64 |
| 18.0 | 18.9 | 18.94 | 19.06 | 0.66 |
| 24.0 | 25.5 | 25.28 | 25.41 | 0.53 |
| 30.0 | 31.4 | 31.61 | 31.72 | 0.33 |
| 36.0 | 37.9 | 37.95 | 37.99 | 0.11 |
| 42.0 | 44.8 | 44.29 | 44.23 | -0.14 |
| 48.0 | 50.7 | 50.63 | 50.43 | -0.39 |
| 54.0 | 56.5 | 56.96 | 56.60 | -0.65 |
| 60.0 | 62.3 | 63.30 | 62.73 | -0.91 |
5
Assay Range
The range of the assay is 1.5 to 54.0 ug/mL. Report results below this range as 54.0 µg/mL or above the analyzer-specific upper LOQ established in your laboratory.
Method Comparison
Correlation studies were performed using CLSI/NCCLS Protocol EP9-A2. Results from the ARK Topiramate assay were compared with results from a commercially available FPIA Immunoassay. The topiramate concentrations ranged from 1.5 µg/mL to 53.4 µg/mL. Results of the Passing-Bablok regression analysis for the study are shown below.
| Slope | 0.99 |
|---|---|
| y-intercept | -0.17 |
| Correlation Coefficient (r²) | 0.99 |
| Number of Samples | 113 |
Precision
Precision was determined as described in CLSI/NCCLS Protocol EP5-A2. Tri-level controls containing topiramate were used in the study. Each level of control 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: