(115 days)
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) | <10% total CV | Sample 1 (2.4 µg/mL): 4.2% CVSample 2 (10.2 µg/mL): 2.7% CVSample 3 (40.2 µg/mL): 3.2% CV |
| Interfering Substances | Measurement of topiramate resulted in ≤10% error | All tested substances (e.g., Albumin, Bilirubin, Cholesterol, Hemoglobin) at clinically high concentrations resulted in ≤10% error. |
| Metabolites (Cross-Reactivity) | Measurement of topiramate resulted in ≤10% error | 9-Hydroxy-topiramate at 40.0 µg/mL resulted in 8.6% error for low topiramate and 3.2% error for high topiramate. |
| Drug Interference | Measurement of topiramate resulted in ≤10% error | All tested co-administered drugs (e.g., Acetaminophen, Carbamazepine, Phenobarbital, Valproic Acid) at high concentrations resulted in ≤10% error. |
| Anticoagulants | No significant difference between serum and plasma recovery | Results indicated no significant difference between serum and plasma recovery. |
| Calibration Curve Stability | Not explicitly stated as acceptance criteria, but reported. | Effective up to 49 days. |
| Reagent On-board Stability | Not explicitly stated as acceptance criteria, but reported. | Effective for up to 60 days. |
2. Sample Size Used for the Test Set and Data Provenance
- Accuracy: Not explicitly stated as a "test set" in the traditional sense. Samples were human serum negative for topiramate, spiked with known topiramate concentrations. Six replicates were performed for each concentration. Data provenance is implied to be laboratory-generated through spiking.
- Linearity: A 60.0 µg/mL serum sample was prepared and proportionally diluted with human serum negative for topiramate. Topiramate concentrations ranged from 0.6 to 60.0 µg/mL. Data provenance is laboratory-generated.
- Method Comparison: 113 samples.
- Data Provenance: Not explicitly stated for this particular study (e.g., country of origin, retrospective/prospective). However, given the context of a 510(k) for an in vitro diagnostic, these samples would typically come from patients, likely collected retrospectively or prospectively for method validation purposes.
- Precision: Tri-level controls were used. Each level was assayed in quadruplicate, twice a day for 20 days (N=160 for each level). Data provenance is laboratory-generated.
- Interfering Substances: Samples were human serum with known levels of topiramate (approximately 5 and 20 µg/mL) spiked with high concentrations of various interfering substances. Data provenance is laboratory-generated.
- Metabolites: Samples were human serum with known levels of topiramate spiked with 9-hydroxy-topiramate. Data provenance is laboratory-generated.
- Drug Interference: Samples were normal human serum with known levels of topiramate (approximately 5 and 20 µg/mL) spiked with high concentrations of various drug compounds. Data provenance is laboratory-generated.
- Anticoagulants: Not explicitly detailed, but implied to involve testing serum and plasma samples containing topiramate. Data provenance is laboratory-generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is an in vitro diagnostic device for quantitative determination of a drug in serum/plasma. The "ground truth" for the test set (e.g., known concentrations for accuracy, reference method results for method comparison) is established through analytical techniques, not expert adjudication of images or clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this device performance is assessed through analytical measurements against known concentrations or a reference method, not through expert adjudication in the context of diagnostic interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices where human readers interpret cases, and the AI's impact on their performance is evaluated. This device is an automated in vitro diagnostic assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are all standalone validations of the analytical performance of the ARK Topiramate Assay. The device is intended for quantitative determination on automated clinical chemistry analyzers, meaning it operates without direct human-in-the-loop interpretation of its primary output.
7. The Type of Ground Truth Used
The ground truth used for these studies includes:
- Known Reference Concentrations: For accuracy and linearity studies, serum samples were spiked with precisely measured, highly pure topiramate to create samples with known theoretical concentrations.
- Reference Method Results: For the method comparison study, results from the ARK Topiramate Assay were compared against a "commercially available FPIA Immunoassay." The results from this predicate method served as the reference or ground truth for comparison.
- Known Spiked Levels: For interference, metabolite, and drug interference studies, known quantities of the interfering substance, metabolite, or drug were added to samples with known topiramate concentrations.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a predefined assay, not the development or training of a machine learning algorithm. Therefore, there is no "training set" in the context of an AI/ML device. The reagents are pre-formulated for the immunoassay.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as point 8.
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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 AssayARKTM Topiramate CalibratorARKTM 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 |
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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.
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807.92 (a)(6): Technological Similarities and Differences to the Predicate
SUBSTANTIAL EQUIVALENCE COMPARATIVE CHART
| Characteristic | Device | Predicate |
|---|---|---|
| Intended Use | ARK™ Topiramate AssayThe ARK™ Topiramate Assay is intendedfor the quantitative determination oftopiramate in human serum or plasma onautomated clinical chemistry analyzers. | Seradyn QMS® Topiramate K070645The Seradyn QMS® Topiramate Assay isintended for the quantitative determination oftopiramate in human serum or plasma onautomated clinical chemistry analyzers. |
| Indications for Use | The results obtained are used in the diagnosisand treatment of topiramate overdose and inmonitoring levels of topiramate to helpensure appropriate therapy. | The results obtained are used in the diagnosisand treatment of topiramate overdose and inmonitoring levels of topiramate to helpensure appropriate therapy. |
| Sample | Serum or plasma | Serum or plasma |
| Methodology | Homogenous enzyme immunoassay (EIA) | Homogenous particle-enhancedturbidometric immunoassay (particleagglutination) (PETIA) |
| ReagentComponents | Two (2) reagent system:Anti-topiramate Antibody/Substrate Reagent(R1) containing rabbit polyclonal antibodiesto topiramate, glucose-6-phosphate,nicotinamide adenine dinucleotide, bovineserum albumin, preservatives, and stabilizersEnzyme Reagent (R2) containing topiramateepitope labeled with bacterial G6PDH,buffer, bovine serum albumin, preservatives,and stabilizers | Two (2) reagent system:Anti-topiramate Antibody Reagent (R1) inbuffers containing protein stabilizers withsodium azideTopiramate-coated Microparticle Reagent(R2) in buffer containing surfactant asstabilizers with sodium azide |
| Platform required | Automated clinical chemistry analyzer | Automated clinical chemistry analyzer |
| Accessory reagents | Calibrators (six levels) 0.0 to 60.0 µg/mLand controls (three levels) | Calibrators (six levels) 0.0 to 32.0 µg/mLand controls (three levels) |
| Testingenvironment | Routine clinical laboratory | Routine clinical laboratory |
| Reagent conditionand 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 tested4x/day or 8x/dayfor 20 days) | Sample 1N 160mean 2.4SD 0.10%CV 4.3Sample 2N 160mean 10.2SD 0.28%CV 2.7 | Sample 1N 80mean 2.94SD 0.12%CV 4.22Sample 2N 80mean 10.14SD 0.34%CV 3.37 |
| Characteristic | Device | Predicate |
| ARK™ Topiramate Assay | Seradyn QMS® Topiramate K070645 | |
| Accuracy-recovery | Percent recoveries from the testing (in sixreplicates) of samples spiked between 1.5and 55.0 µg/mL were all within 10% of theirtheoretical levels | Percent recoveries from the testing (intriplicate) of samples spiked between 1.28and 32.00 µg/mL were all within 10% oftheir theoretical levels |
| MethodComparison (eachassay compared toa commercially-available FPIAimmunoassay | No of samples: 113Range of samples: 1.5 µg/mL to 53.4 µg/mLSlope: 0.99y-intercept: - 0.17correlation coefficient (r²): 0.99 | No of samples: 148Range of samples: 1.56 µg/mL to 30.72 µg/mLSlope: 0.962y-intercept: 0.228correlation coefficient (r²): 0.986 |
| Interferingsubstances | A series of biological substances and co-administered drugs were tested for potentialinterference at two levels (approx. 5 and 20µg/mL) of topiramate. The resultsdemonstrated a ≤ 10% difference betweenthe control samples and the challengedsamples. | A series of biological substances and co-administered drugs were tested for potentialinterference at two levels (approx. 5 and 20µg/mL) of topiramate. The resultsdemonstrated a ≤ 10% difference betweenthe control samples and the challengedsamples. |
Comparison between the ARK™ Topiramate Assay and the Seradyn QMS® Topiramate Assay
ARK Diagnostics, Inc. -- 510(k) Summary, Rev. 4
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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 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
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| TheoreticalConcentration(µg/mL) | Mean RecoveredConcentration(µg/mL) | PercentRecovery |
|---|---|---|
| 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 OrderPredictedResults | 2nd OrderPredictedResults | % Difference(AcceptanceCriteria: ±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 |
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Assay Range
The range of the assay is 1.5 to 54.0 ug/mL. Report results below this range as <1.5 ug/mL or below the analyzer-specific lower LOQ established in your laboratory. Report results above 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: <10% total CV.
| Within Run | Between Day | Total | ||||||
|---|---|---|---|---|---|---|---|---|
| Sample | N | Mean(µg/mL) | SD | CV(%) | SD | CV(%) | SD | CV(%) |
| 1 | 160 | 2.4 | 0.08 | 3.4 | 0.05 | 2.0 | 0.10 | 4.2 |
| 2 | 160 | 10.2 | 0.24 | 2.4 | 0.14 | 1.4 | 0.28 | 2.7 |
| 3 | 160 | 40.2 | 1.19 | 2.9 | 0.64 | 1.6 | 1.29 | 3.2 |
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Interfering Substances
Interference studies were conducted using CLSI/NCCLS Protocol EP7-A2 as a guideline. Clinically high concentrations of the following potentially interfering substances in serum with known levels of topiramate (approximately 5 and 20 ug/mL) were evaluated. Each sample was assayed using the ARK Topiramate Assay, along with a serum control of topiramate. Measurement of topiramate resulted in ≤10% error in the presence of interfering substances at the levels tested.
| InterferingSubstance | InterferentConcentration |
|---|---|
| Albumin | 12 g/dL |
| Bilirubin | 60 mg/dL |
| Cholesterol | 301 mg/dL |
| Gamma-Globulin | 10 g/dL |
| Hemoglobin | 1000 mg/dL |
| Heparin | 200 units/mL |
| Rheumatoid Factor | 1000 IU/mL |
| Triglycerides | 1105 mg/dL |
| Uric Acid | 25 mg/dL |
Metabolites
ARK Topiramate Assay serum and plasma results are unlikely to be affected by metabolism of topiramate drug, since plasma levels of metabolites are usually not clinically significant. The following metabolite was tested for crossreactivity. Measurement of topiramate resulted in ≤ 10% error in the presence of 9-Hydroxy-topiramate at the level tested.
| Metabolite | MetaboliteConc.(µg/mL) | PercentCross-Reactivity | PercentInterference | ||
|---|---|---|---|---|---|
| LowTopiramate | HighTopiramate | LowTopiramate | HighTopiramate | ||
| 9-Hydroxy-topiramate | 40.0 | 1.2 | 1.6 | 8.6 | 3.2 |
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Drug Interference
Topiramate-selective antibody did not crossreact with other anti-epileptic or coadministered drugs tested. A high concentration of each compound was spiked into normal human serum with known levels of topiramate (approximately 5 and 20 µg/mL) and assayed along with a serum control of topiramate. Measurement of topiramate resulted in ≤ 10% error in the presence of drug compounds at the levels tested.
Data are representative of performance on automated clinical chemistry analyzers. Each laboratory is responsible for verification of performance using instrument parameters established for their analyzer.
| Compound | Concentration(µg/mL) | Compound | Concentration(µg/mL) |
|---|---|---|---|
| Acetaminophen | 50 | Levitiracetam | 200 |
| Acetozolamide | 50 | Methysergide | 100 |
| Alprazolam | 20 | Metoprolol | 100 |
| Amitriptyline | 10 | Nadolol | 150 |
| Acetylsalicylic acid | 100 | Naproxen | 600 |
| Atenolol | 50 | Nimodipine | 100 |
| Caffeine | 100 | Nortriptyline | 10 |
| Carbamazepine | 100 | Oxcarbazepine | 50 |
| Chlorthalidone | 100 | Phenelzine | 15 |
| Clonazepam | 50 | Phenobarbital | 40 |
| Clorazepate | 20 | Phenytoin | 50 |
| Diazepam | 50 | Primidone | 100 |
| Dichlorphenamide | 40 | Protriptyline | 20 |
| Ethosuxamide | 500 | Salicylic Acid | 750 |
| Famotidine | 50 | Sulfanilamide | 2000 |
| Felbamate | 500 | Tiagabine | 200 |
| Flurazepam | 20 | Tolbutamide | 750 |
| Furosemide | 10 | Valproic Acid | 200 |
| Gabapentin | 100 | Verapamil | 100 |
| Hydrochlorothiazide | 60 | Vigabatrin | 150 |
| Ibuprofen | 500 | Zonisamide | 200 |
| Lamotrogine | 100 |
{8}------------------------------------------------
Anticoagulants
Studies were conducted to determine the performance characteristics of the assay for both serum and plasma samples containing topiramate.
The results indicate that there is no significant difference between the recovery of topiramate in serum or plasma.
On-Board Stability
Calibration Curve Stability: A stored calibration was effective up to 49 days based on supporting data.
Reagent on-board stability: Reagents were effective when stored with caps after transfer to analyzer specific reagent containers for up to 60 days based on supporting data.
807.92 (b)(3): Conclusions from Nonclinical Testing
As summarized above, the ARK Topiramate Assay, the ARK Topiramate Calibrator and the ARK Topiramate Control are substantially equivalent to the Seradyn QMS® Topiramate Assay system. The ARK test system was shown to be safe and effective for its intended use based on performance studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
''
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 18 2009
ARK Diagnostics. Inc. c/o Mr. Johnny Valdez President 1190 Bordeaux Drive Sunnyvale, CA 94089
Re: K083799
Trade name: ARK Topiramate Assay, ARK Topiramate Calibrator, ARK Topiramate Control Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenylhydantoin Test System Regulatory Class: Class II Product Code: NWM, DLJ, LAS Dated: April 3, 2009 Received: April 6, 2009
Dear Mr. Valdez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807);, labeling (21 CFR Parts 801 and 809): medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of
{10}------------------------------------------------
Page - 2
substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
AC
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(K) Number (if known): K083799
Device Name:
ARKTM Topiramate Assay ARKTM Topiramate Calibrator ARKTM Topiramate Control
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 Assay.
The ARK™ Topiramate Control is intended for use in quality control of the ARK Topiramate Assay.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083799
§ 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.