(146 days)
No
The device description and performance studies detail a standard homogeneous enzyme immunoassay for quantitative determination of a drug. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance metrics.
No.
Explanation: This device is an in vitro diagnostic (IVD) assay designed to quantify levetiracetam levels in human serum or plasma. It is used to aid in the management of patients by providing drug concentrations, not to directly treat or modify a physiological function.
Yes
The device quantitatively determines levetiracetam concentrations, which "can be used as an aid in management of patients treated with levetiracetam," indicating its role in assessing a patient's condition to help guide medical decisions.
No
The device description clearly states it is a homogeneous enzyme immunoassay consisting of reagents (RI and R2), calibrators, and controls, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "intended for the quantitative determination of levetiracetam in human serum or plasma". This indicates that the device is used to examine specimens derived from the human body (serum or plasma) to provide information for medical purposes (management of patients treated with levetiracetam).
- Device Description: The description details a "homogeneous enzyme immunoassay" that measures the concentration of levetiracetam in a specimen. This is a common type of in vitro diagnostic test.
- Performance Studies: The document includes detailed performance studies (Accuracy, Linearity, Method Comparison, Precision, Interfering Substances, etc.) which are typical for IVD devices to demonstrate their analytical performance.
- Calibrators and Controls: The mention of "Calibrator" and "Control" kits further confirms its use in a clinical laboratory setting for performing diagnostic tests.
- Predicate Device: The listing of a "Predicate Device" (K083799 ARK™ 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 regulatory process for new IVDs.
- Intended User / Care Setting: The "Routine clinical laboratory" is a typical setting where IVD tests are performed.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARK™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetiracetam concentrations can be used as an aid in management of patients treated with levetiracetam.
The ARKTM Levetiracetam Calibrator is intended for use in calibration of the ARK Levetiracetam Assay.
The ARK™ Levetiracetam Control is intended for use in quality control of the ARK Levetiracetam Assay.
Product codes
ORI, LAS, DLJ
Device Description
The ARK Levetiracetam Assay is a homogeneous immunoassay based on competition between drug in the specimen and levetiracetam 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 Levetiracetam Assay consists of reagents RI anti-levetiracetam polyclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme. The ARK Levetiracetam Calibrator consists of a six-level set to calibrate the assay, and the ARK Levetiracetam Control consists of a three-level set used for quality control of the assay.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
STUDY TYPE: Limit of Quantitation (LOQ)
SAMPLE SIZE: Not specified.
KEY RESULTS: The LOQ was determined to be 2.0 µg/mL.
STUDY TYPE: Accuracy (analytical recovery)
SAMPLE SIZE: Not specified.
DATA SOURCE: Human serum negative for levetiracetam spiked with concentrated levetiracetam drug.
KEY RESULTS: Percent recovery values ranged from 94.6% to 105.3% for theoretical concentrations from 2.0 to 100.0 µg/mL.
STUDY TYPE: Linearity
SAMPLE SIZE: Not specified.
DATA SOURCE: Human serum negative for levetiracetam and a 100.0 µg/mL serum sample.
KEY RESULTS: A linear relationship was demonstrated between 2.0 and 100.0 µg/mL. The percent difference between 1st and 2nd order predicted values was within acceptance criteria (±10%, or ±15% below 3.0 µg/mL).
STUDY TYPE: Method Comparison (Correlation studies)
SAMPLE SIZE: 305 samples
DATA SOURCE: ARK Levetiracetam assay results compared with a reference LC/MS/MS method.
KEY RESULTS: Slope = 1.01 (95% CI: 0.99 to 1.03), y-intercept = 0.25 (95% CI: -0.24 to 0.63), Correlation Coefficient (r2) = 0.97 (95% CI: 0.96 to 0.97).
STUDY TYPE: Precision
SAMPLE SIZE: 160 replicates for each level (low, mid, high) of controls and human serum pools.
DATA SOURCE: Trilevel controls and three human serum pooled specimens containing levetiracetam.
KEY RESULTS: Total CVs for controls ranged from 3.7% to 4.5%. Total CVs for human serum samples ranged from 4.1% to 4.8%. All total CVs were
§ 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
2009 - 2 2009
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 K091653.
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: October 23, 2009
807.92 (a)(2): Device name- trade name and common name, and classification
| Trade name: | ARK™ Levetiracetam Assay |
|---|---|
| ARK™ Levetiracetam Calibrator | |
| ARK™ Levetiracetam 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
K083799 (bundled) ARKTM Topiramate Assay r ARKTM Topiramate Calibrator ARK™ Topiramate Control
ARK Diagnostics, Inc. - 510(k) Summary ARK Levetiracetam Assay
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807.92 (a)(4): Device Description
The ARK Levetiracetam Assay is a homogeneous immunoassay based on competition between drug in the specimen and levetiracetam 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 Levetiracetam Assay consists of reagents RI anti-levetiracetam polyclonal antibody with substrate and R2 levetiracetam labeled with bacterial G6PDH enzyme. The ARK Levetiracetam Calibrator consists of a six-level set to calibrate the assay, and the ARK Levetiracetam 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™ Levetiracetam Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of levetiracetam in human serum or plasma on automated clinical chemistry analyzers. Levetirations can be used as an aid in management of patients treated with levetiracetam.
The ARKTM Levetiracetam Calibrator is intended for use in calibration of the ARK Levetiracetam Assay.
The ARK™ Levetiracetam Control is intended for use in quality control of the ARK Levetiracetam Assay.
ARK Diagnostics, Inc. - 510(k) Summary ARK Levetiracetam Assay
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807.92 (a)(6): Technological Similarities and Differences to the Predicate
SUBSTANTIAL EQUIVALENCE COMPARATIVE CHART
| Characteristic | Device | Predicate |
|---|---|---|
| ARK™ Levetiracetam Assay | ARK™ Topiramate Assay K083799 | |
| Intended Use | The ARK™ Levetiracetam Assay is intended | |
| for the quantitative determination of | ||
| levetiracetam 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 | The results obtained are used in the diagnosis | |
| and treatment of levetiracetam overdose and | ||
| in monitoring levels of levetiracetam 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 enzyme immunoassay (EIA) |
| Reagent | ||
| Components | Two (2) reagent system: | |
| Anti-levetiracetam Antibody/Substrate | ||
| Reagent (R1) containing rabbit polyclonal | ||
| antibodies to levetiracetam, glucose-6- | ||
| phosphate, nicotinamide adenine | ||
| dinucleotide, bovine serum albumin, | ||
| preservatives, and stabilizers |
Enzyme Reagent (R2) containing
levetiracetam labeled with bacterial G6PDH,
buffer, bovine serum albumin, preservatives,
and stabilizers | Two (2) reagent system:
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 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™ Levetiracetam Assay and the ARK™ Topiramate Assay
ARK Diagnostics, Inc. - 510(k) Summary ARK Levetiracetam Assay
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807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data
Limit of Quantitation (LOO)
The LOQ of the ARK Levetiracetam 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 2.0 µg/mL.
Accuracy
Accuracy (analytical recovery) was performed by adding concentrated leveiracetam drug into human serum negative for levetiracetam. A stock concentrate of highly pure levetiracetam was added volumetrically to human serum negative for levetiracetam, 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.
| $% Recovery = 100 X$ | $\frac{Mean recovered concentration}{Theoretical concentration}$ |
|---|---|
| ----------------------- | ------------------------------------------------------------------ |
| Theoretical
Concentration
(µg/mL) | Mean Recovered
Concentration
(µg/mL) | Percent
Recovery |
|-----------------------------------------|--------------------------------------------|---------------------|
| 2.0 | 1.9 | 95.8 |
| 4.0 | 3.8 | 94.6 |
| 10.0 | 10.0 | 100.0 |
| 20.0 | 19.2 | 95.9 |
| 45.0 | 44.1 | 98.0 |
| 80.0 | 79.3 | 99.1 |
| 100.0 | 105.3 | 105.3 |
ARK Diagnostics, Inc. - 510(k) Summary ARK Levetiracetam Assay
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Linearity
Linearity studies were performed as suggested in CLSUNCCLS Protocol EP6-A. A 100.0 µg/mL serum sample was prepared and dilutions were made proportionally with human serum negative for levetiracetam. Levetiracetam concentrations ranged from 1.0 to 100.0 µg/mL. Linearity at specific dilutions was considered acceptable if the percent difference was ±10% between the predicted 14 and 2nd order regressed values or ±15% below 3.0 µg/mL. A linear relationship was demonstrated between 2.0 and 100.0 µg/mL. Results are shown below.
.
| Estimated Value
(µg/mL) | Results
(µg/mL) | 1st Order
Predicted
Results | 2nd Order
Predicted
Results | % Difference
(Acceptance
Criteria: ±10%) |
|----------------------------|--------------------|-----------------------------------|-----------------------------------|------------------------------------------------|
| 2.0 | 1.9 | 2.1 | 2.4 | 13.2 |
| 3.0 | 3.2 | 3.1 | 3.4 | 7.6 |
| 4.0 | 4.1 | 4.2 | 4.3 | 4.8 |
| 5.0 | 5.3 | 5.2 | 5.3 | 3.1 |
| 6.0 | 6.4 | 6.2 | 6.3 | 2.0 |
| 7.0 | 7.6 | 7.2 | 7.3 | 1.3 |
| 8.0 | 8.4 | 8.3 | 8.3 | 0.7 |
| 9.0 | 9.5 | 9.3 | 9.3 | 0.3 |
| 10.0 | 10.7 | 10.3 | 10.3 | -0.1 |
| 20.0 | 20.7 | 20.6 | 20.4 | -1.3 |
| 30.0 | 31.0 | 31.0 | 30.5 | -1.4 |
| 40.0 | 41.3 | 41.3 | 40.8 | -1.2 |
| 50.0 | 51.9 | 51.6 | 51.1 | -0.9 |
| 60.0 | 60.3 | 61.9 | 61.6 | -0.5 |
| 70.0 | 71.2 | 72.2 | 72.1 | -0.1 |
| 80.0 | 81.4 | 82.5 | 82.8 | 0.3 |
| 90.0 | 93.7 | 92.8 | 93.5 | 0.7 |
| 100.0 | 104.6 | 103.1 | 104.3 | 1.2 |
ARK Diagnostics, Inc. - 510(k) Summary ARK Levetiracetam Assay
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Assay Range
The range of the assay is 2.0 to 100.0 ug/mL. Report results below this range as 100.0 ug/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 levetiracetam in the undiluted specimen.
Method Comparison
Correlation studies were performed using CLSI/NCCLS Protocol EP9-A2. Results from the ARK Levetiracetam assay were compared with results from a reference LC/MS/MS method. The levetiracetam concentrations ranged from 2.0 ug/mL to 86.4 ug/mL. Results of the Passing-Bablok regression analysis for the study are shown below (with 95% confidence limits).
| Slope | 1.01 | (0.99 to 1.03) |
|---|---|---|
| y-intercept | 0.25 | (-0.24 to 0.63) |
| Correlation Coefficient (r2) | 0.97 | (0.96 to 0.97) |
| Number of Samples | 305 |
Image /page/5/Figure/6 description: This image is a scatter plot comparing two different assays, ARK Levetiracetam Assay and LC/MS/MS, both measured in micrograms per milliliter. The x-axis represents the LC/MS/MS assay, while the y-axis represents the ARK Levetiracetam Assay. The plot includes a line of identity and a Passing & Bablok fit line, represented by the equation y = 0.25 + 1.01x.
ARK Diagnostics, Inc. - 510(k) Summary ARK Levetiracetam Assay
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Precision
Precision was determined as described in CLSI/NCCLS Protocol EP5-A2. Trilevel controls and three human serum pooled specimens containing levetiracetam 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: