(469 days)
Not Found
No
The device description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies focus on standard analytical validation metrics for an immunoassay.
No
This device is an in vitro diagnostic (IVD) assay designed to measure lacosamide levels, not to treat a condition. While the measurements are used to help ensure appropriate therapy, the assay itself is not a therapeutic intervention.
Yes
The device quantitatively determines lacosamide levels in human serum, with the measurements used for "monitoring levels of lacosamide to help ensure appropriate therapy," which is a diagnostic purpose to guide treatment.
No
The device is a homogeneous enzyme immunoassay, which is a laboratory test kit consisting of chemical reagents (R1 and R2). This is a hardware-based diagnostic assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states the device is for the "quantitative determination of lacosamide in human serum". This involves testing a biological sample (human serum) outside of the body (in vitro) to obtain diagnostic information (monitoring drug levels to help ensure appropriate therapy).
- Device Description: The description details a "homogeneous enzyme immunoassay" which is a common method used in in vitro diagnostics to measure substances in biological samples.
- Sample Type: The assay is performed on "human serum".
- Purpose: The measurements are used in "monitoring levels of lacosamide to help ensure appropriate therapy," which is a diagnostic purpose related to patient treatment.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
Product codes (comma separated list FDA assigned to the subject device)
NWM
Device Description
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay based on competition between drug in the specimen and lacosamide 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 related 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 coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Lacosamide Assay consists of reagents R1 anti-lacosamide polyclonal antibody with substrate and R2 lacosamide labeled with bacterial G6PDH enzyme.
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
Clinical Laboratories; Prescription Use Only
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, sample size, AUC, MRMC, standalone performance, key results)
- Limit of Quantitation (LoQ): The LoQ for the ARK Lacosamide Assay was determined to be 0.40 ug/mL, with acceptable inter-assay precision (1.00 µg/mL, or ≤0.20 µg/mL for concentrations ≤1.00 µg/mL.
- Method Comparison (Passing-Bablok): Slope: 1.01 (0.99 to 1.04), y-intercept: 0.03 (-0.10 to 0.15), Correlation Coefficient (r2): 0.98 (0.98 to 0.99).
- Precision: Total CV ≤10% (observed range 3.9% to 4.5%).
- Interfering Substances: ≤10% error.
- Specificity: O-Desmethyl lacosamide metabolite cross-reactivity
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name.
August 5, 2021
ARK Diagnostics, Inc. Thomas Houts Director, Quality Regulatory and Planning 48089 Fremont Boulevard Fremont, CA 94538
Re: K201089
Trade/Device Name: ARK Lacosamide Assay Regulation Number: 21 CFR 862.3350 Regulation Name: Diphenylhydantoin test system Regulatory Class: Class II Product Code: NWM Dated: October 28, 2020 Received: November 19, 2020
Dear Thomas Houts:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201089
Device Name ARK Lacosamide Assay
Indications for Use (Describe)
ARK Lacosamide Assay:
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5: 510(k) SUMMARY
This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is K201089.
| 807.92 (a)(1): Name: | ARK Diagnostics, Inc. |
|---|---|
| Address: | 48089 Fremont Blvd |
| Fremont, CA 94538 USA | |
| Owner Operator Number: | 10027663 |
| Establishment Registration: | 3005755244 |
| Phone: | (510) 270-6270 |
| FAX: | (510) 270-6298 |
| Contact: | Thomas Houts, Ph.D. |
| Director, Quality, Regulatory and Planning | |
| Email: tom@arkt-dm.com | |
| Direct phone: 510-270-6296 |
Date Prepared: April 22, 2020
807.92 (a)(2): Device name - trade name and common name, and classification
| Trade Name: | ARK Lacosamide Assay |
|---|---|
| ------------- | ---------------------- |
Common Name: Homogeneous Enzyme Immunoassay
Classification:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NWM | Class II | 862.3350 | |
| Diphenylhydantoin Test System | Toxicology | ||
| (91) |
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807.92 (a)(3): Identification of the legally marketed predicate device
Predicate Device Name: ARKTM Topiramate Assay Predicate 510(k) Number: K083799
807.92 (a)(4): Device Description
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay based on competition between drug in the specimen and lacosamide 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 related 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 coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Lacosamide Assay consists of reagents R1 anti-lacosamide polyclonal antibody with substrate and R2 lacosamide labeled with bacterial G6PDH enzyme.
Summary and Explanation of Test
Lacosamide (Vimpat®, UCB, Inc.) [(R)-2-acetamido-N-benzyl-3-methoxypropionamide] is indicated for adjunctive therapy of partial-onset seizures in patients ≥17 years.
807.92 (a)(5): Intended Use / Indications for Use
ARK Lacosamide Assay
The ARK Lacosamide Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of lacosamide in human serum on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of lacosamide to help ensure appropriate therapy.
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807.92 (a)(6): Technological Similarities and Differences to the Predicate
SUBSTANTIAL EQUIVALENCE COMPARATIVE TABLES
Predicate Device Candidate Device Characteristic ARKTM Topiramate Assay (K083799) ARK™ Lacosamide Assay The ARK Topiramate The ARK Lacosamide is Assay is Assay a a homogeneous enzyme immunoassay intended homogeneous enzyme immunoassay Intended Use the quantitative determination intended for the quantitative determination of for of topiramate in human serum or plasma on lacosamide in human serum on automated automated clinical chemistry analyzers. clinical chemistry analyzers. The results obtained are used in the diagnosis The measurements obtained are used in Indications for and treatment of topiramate overdose and in monitoring levels of lacosamide to help monitoring levels of topiramate to help Use ensure appropriate therapy. ensure appropriate therapy. Sample Matrix Human serum or plasma Human serum Two (2) reagent system: Two (2) reagent system: Anti-topiramate Antibody/Substrate Reagent Anti-lacosamide Antibody/Substrate Reagent (R1) containing rabbit polyclonal antibodies (R1) containing rabbit polyclonal antibodies glucose-6-phosphate, topiramate、 lacosamide、 glucose-6-phosphate, to to nicotinamide adenine dinucleotide, boyine Reagent nicotinamide adenine dinucleotide, bovine Components serum albumin, preservatives, and stabilizers serum albumin, sodium azide, and stabilizers Enzyme Reagent (R2) containing topiramate Enzyme Reagent (R2) containing lacosamide epitope labeled with bacterial G6PDH, labeled with bacterial G6PDH. buffer. bovine serum albumin, sodium azide, and buffer, bovine serum albumin, preservatives, and stabilizers stabilizers Methodology Homogeneous Enzyme Immunoassay (EIA) Same Platform Same Automated Clinical Chemistry Analyzer Required User Clinical Laboratories; Prescription Use Only Same Environment Liquid - Ready to use Reagents Form Same 2-8° C until expiration date Storage Same Analyte Topiramate Lacosamide
Comparison between the ARK™ Lacosamide Assay and the ARK™ Topiramate Assay
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807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data
The following performance characteristics were obtained on the Beckman Coulter AU680® automated clinical chemistry analyzer.
Limit of Quantitation (LoQ)
The LoQ for the ARK Lacosamide Assay was determined to be 0.40 ug/mL, and may depend on analyzer-specific performance. The LoQ was determined according to CLSI EP17-A2 and is defined as the lowest concentration for which acceptable inter-assay precision (24.00 µg/mL) may be assayed by dilution of the specimen into the measurement range for a quantitative result or otherwise reported as detected above the measurement range. Multiply the assay result by the dilution factor to obtain the concentration of lacosamide in the undiluted specimen.
Recovery
Analytical recovery throughout the measurement range was performed by adding concentrated lacosamide drug into human serum negative for lacosamide. A certified stock concentrate of highly pure lacosamide was added volumetrically to human serum negative for lacosamide, representing drug concentrations across the assay range. Two analytical runs of three replicates of each sample were assaved on an automated clinical chemistry analyzer. The results of the six replicates of each sample were averaged and compared to the target concentration and percent recovery calculated. Recovery at all samples tested was within ±10% of the expected sample concentration.
| Theoretical
Concentration
(µg/mL) | Mean Recovered
Concentration
(µg/mL) | Percent
Recovery (%) |
|-----------------------------------------|--------------------------------------------|-------------------------|
| 0.40 | 0.36 | 90.4 |
| 0.50 | 0.47 | 93.3 |
| 1.00 | 1.04 | 104.2 |
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| Theoretical
Concentration
(µg/mL) | Mean Recovered
Concentration
(µg/mL) | Percent
Recovery (%) |
|-----------------------------------------|--------------------------------------------|-------------------------|
| 3.00 | 3.07 | 102.3 |
| 6.00 | 6.15 | 102.6 |
| 9.00 | 8.92 | 99.1 |
| 15.00 | 14.42 | 96.1 |
| 20.00 | 21.15 | 105.8 |
Linearity
Linearity studies were performed as suggested in CLSI EP06-A. A 30.00 ug/mL lacosamide serum sample was prepared and dilutions were made proportionally with human serum negative for lacosamide. Two analytical runs of three replicates of each sample were assayed on an automated clinical chemistry analyzer. The results of the six replicates of each sample were averaged. The data were analyzed using linear regression as well as non-linear fitted polynomial regression. Linearity at specific dilutions was considered acceptable if the percent difference was ±10% between the predicted 1st and 2nd order regressed values at concentrations >1.00 µg/mL, or ≤0.20 µg/mL at concentrations ≤1.00 µg/mL. A linear relationship was demonstrated between 0.40 and 25.00 µg/mL (y = 0.9998x - 0.0170).
| Nominal
(µg/mL) | Measured
Results
(µg/mL) | 1st Order
Predicted
Results | 2nd Order
Predicted
Results | Difference |
|--------------------|--------------------------------|-----------------------------------|-----------------------------------|-------------|
| 0.00 | 0.00 | -0.02 | -0.08 | NA |
| 0.40 | 0.36 | 0.38 | 0.33 | -0.05 µg/mL |
| 1.50 | 1.55 | 1.48 | 1.45 | -2.0 % |
| 3.00 | 2.95 | 2.98 | 2.98 | 0.0 % |
| 6.00 | 5.83 | 5.98 | 6.02 | 0.7 % |
| 9.00 | 8.91 | 8.98 | 9.05 | 0.7 % |
| 12.00 | 12.01 | 11.98 | 12.05 | 0.6 % |
| 15.00 | 15.02 | 14.98 | 15.04 | 0.4 % |
| 18.00 | 18.11 | 17.98 | 18.01 | 0.2 % |
| 21.00 | 21.41 | 20.98 | 20.97 | -0.1 % |
| 25.00 | 24.55 | 24.98 | 24.87 | -0.4 % |
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Method Comparison
Method comparison studies were performed using CLSI EP09-A3 as a guideline. Method comparison was conducted with 150 unaltered, human serum specimens that are not individually identifiable. Results from the ARK Lacosamide Assay were compared with results from LC-MS/MS. The lacosamide concentrations ranged from 0.65 µg/mL to 23.50 µg/mL. Results of the Passing-Bablok regression analysis are shown below (with 95% confidence limits).
| Slope | 1.01 | (0.99 to 1.04) |
|---|---|---|
| y-intercept | 0.03 | (-0.10 to 0.15) |
| Correlation Coefficient (r2) | 0.98 | (0.98 to 0.99) |
| Number of Samples | 150 |
Image /page/8/Figure/3 description: This image is a scatter plot comparing ARK Lacosamide Assay and LC-MS/MS measurements, both in micrograms per milliliter. The x-axis represents LC-MS/MS values ranging from 0 to 25, while the y-axis represents ARK Lacosamide Assay values in the same range. A cluster of data points forms a strong positive correlation, closely aligned with a blue trend line, indicating agreement between the two measurement methods. The data suggests a linear relationship between the two assays.
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Precision
Precision was determined as described in CLSI EP05-A3. Tri-level controls and three samples of lacosamide in pooled human serum were used in the study. Data were collected on a single analyzer over twenty (20) non-consecutive days. Two (2) calibrations were performed according to requirements for quality control. 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: ≤10% total CV.
| Sample | N | Mean
(µg/mL) | Within Run | | Between Day | | Total | |
|------------------------|-----|-----------------|------------|-----------|-------------|-----------|-------|-----------|
| | | | SD | CV
(%) | SD | CV
(%) | SD | CV
(%) |
| ARK Lacosamide Control | | | | | | | | |
| LOW | 160 | 1.55 | 0.049 | 3.1 | 0.049 | 3.1 | 0.070 | 4.5 |
| MID | 160 | 7.13 | 0.202 | 2.8 | 0.204 | 2.9 | 0.287 | 4.0 |
| HIGH | 160 | 14.94 | 0.450 | 3.0 | 0.445 | 3.0 | 0.664 | 4.4 |
| Human Serum | | | | | | | | |
| LOW | 160 | 1.49 | 0.045 | 3.0 | 0.037 | 2.5 | 0.058 | 3.9 |
| MID | 160 | 7.10 | 0.175 | 2.5 | 0.217 | 3.1 | 0.283 | 4.0 |
| HIGH | 160 | 15.18 | 0.456 | 3.0 | 0.432 | 2.8 | 0.657 | 4.3 |
Interfering Substances
Interference studies were conducted using CLSI EP07-A3 as a guideline. Clinically high concentrations of the following potentially interfering substances in serum with known levels of lacosamide (2.0 and 15.0 µg/mL) were evaluated. Two analytical runs of three replicates of each sample (6 replicates total) were assayed using the ARK Lacosamide Assay, along with a serum control of lacosamide. The mean results of lacosamide were calculated and the percentage recovery relative to the serum control mean result was determined. Measurement of lacosamide resulted in ≤10% error in the presence of interfering substances at the levels tested.
| Percentage Recovery (%) | |||
|---|---|---|---|
| Interfering | |||
| Substance | Interferent | ||
| Concentration | 2.0 µg/mL | ||
| Lacosamide | 15.0 µg/mL | ||
| Lacosamide | |||
| Albumin | 12 g/dL | 99.8 | 101.7 |
| Bilirubin - conjugated | 70 mg/dL | 97.3 | 96.5 |
| Bilirubin - unconjugated | 70 mg/dL | 101.1 | 98.3 |
| Cholesterol | 620 mg/dL | 95.8 | 100.1 |
| Gamma-Globulin | 12 g/dL | 103.5 | 98.5 |
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| Percentage Recovery (%) | |||
|---|---|---|---|
| Interfering | |||
| Substance | Interferent | ||
| Concentration | 2.0 µg/mL | ||
| Lacosamide | 15.0 µg/mL | ||
| Lacosamide | |||
| Hemoglobin | 1000 mg/dL | 101.0 | 101.6 |
| Rheumatoid Factor | 1000 IU/mL | 97.3 | 96.8 |
| Triglycerides | 1000 mg/dL | 97.9 | 96.2 |
| Uric Acid | 30 mg/dL | 102.5 | 96.6 |
Specificity
Lacosamide is eliminated primarily from the systemic circulation by renal excretion and biotransformation. After oral and intravenous administration, approximately 95% of lacosamide administered is recovered in the urine and less than 0.5% in the feces. The major compounds excreted are unchanged lacosamide (approximately 40% of the dose), its O-desmethyl metabolite (approximately 30%), and a structurally unknown polar fraction (~20%). The plasma circulating levels of the major human metabolite, O-desmethyl-lacosamide, is approximately 10% of that of lacosamide. This metabolite has no known pharmacological activity.
The crossreactivity of O-desmethyl lacosamide metabolite (5.0 ug/mL or 30.0 ug/mL) in the ARK Lacosamide Assay was not clinically significant (