(261 days)
Not Found
No
The device description and performance studies focus on a homogeneous enzyme immunoassay and standard analytical performance characteristics, with no mention of AI or ML.
No
The device is an in vitro diagnostic assay used for quantitative determination of methotrexate in human serum or plasma to monitor drug levels. It does not directly treat or cure a disease.
Yes
The device is described as an "enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma" and its measurements are "used in monitoring levels of methotrexate to help ensure appropriate therapy." This indicates it is used to measure a substance in the body for the purpose of monitoring a medical condition or treatment, which falls under the definition of a diagnostic device.
No
The device description clearly outlines a homogeneous enzyme immunoassay consisting of chemical reagents (R1 and R2), calibrators, controls, and a dilution buffer. These are physical components, not software. The assay is intended to be run on automated clinical chemistry analyzers, which are also hardware.
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 for the "quantitative determination of methotrexate in human serum or plasma". This indicates that the device is used to test specimens taken from the human body.
- Device Description: The description details a "homogeneous enzyme immunoassay" that uses reagents to measure a substance (methotrexate) in a biological sample. This is a characteristic of an in vitro diagnostic test.
- Specimen Type: The assay is designed to be used with "human serum or plasma", which are biological specimens.
- Purpose: The measurements obtained are used "in monitoring levels of methotrexate to help ensure appropriate therapy," which is a clinical purpose related to patient care.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety or suitability of a transfusion or transplantation, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy.
Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate Assay.
Product codes
LAO
Device Description
The ARK Methotrexate Assay is a homogeneous immunoassay based on competition between drug in the specimen and Methotrexate 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 coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Methotrexate Assay consists of reagents R1 anti-Methotrexate polyclonal antibody with substrate and R2 Methotrexate labeled with bacterial G6PDH enzyme. The ARK Methotrexate Calibrator consists of a six-level set to calibrate the assay, and the ARK Methotrexate Control consists of a six-level set used for quality control of the assay (tri-level calibration range set and tri-level high range set). The ARK Methotrexate Dilution Buffer is equivalent to zero calibrator (Calibrator A).
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
Validation and verification activities were performed which included analytical performance studies to ensure that the performance of the ARK Methotrexate Assay as used on the Beckman Coulter AU680 analyzer is substantially equivalent to the performance of the assay as used on the Roche/Hitachi 917 analyzer (K111904). The following performance characteristics were evaluated:
- Limit of Blank
- Limit of Detection
- Limit of Quantitation
- Recovery
- Linearity
- Accuracy (Method Comparison)
- Precision
- Specificity
- Cross-reactivity
- Carry-over
- Dilution Recovery
- On-board Stability
The pre-determined Pass/Fail acceptance criteria were met for all of the above performance studies.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ARK DIAGNOSTICS, INC. CHERRY MUN MANAGER, QUALITY AND REGULATORY AFFAIRS 48089 FREMONT BOULEVARD FREMONT CA 94538
Re: K163359
Trade/Device Name: ARK Methotrexate Assay Regulation Name: Unclassified, 510(k) required Product Code: LAO Dated: July 18, 2017 Received: July 19, 2017
Dear Cherry Mun:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number
1
(800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Special 510(k) Summary
This summary of safety and effectiveness information for the ARK™ Methotrexate Assay System on the Beckman Coulter AU680 automated clinical chemistry analyzer is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K163359.
| 807.92 (a)(1): Name: | ARK Diagnostics, Inc. |
|---|---|
| Address: | 48089 Fremont Blvd. |
| Fremont, CA 94538 | |
| Owner Operator Number: | 10027663 |
| Establishment Registration: | 3005755244 |
| Phone: | (510) 270-6270 |
| Fax: | (510) 270-6298 |
| Contact: | Cherry Mun – (510) 270-6288 |
| Manager, Quality and Regulatory Affairs |
Date Prepared: August 15, 2017
807.92 (a)(2): Device name – trade name and common name, and classification
| Trade Name: | ARK™ Methotrexate Assay |
|---|---|
| Common Name: | Homogeneous Enzyme Immunoassay |
| Classification: | 21 CFR 862 Clinical Chemistry Test System - |
| Toxicology (91); Test Code LAO; Enzyme | |
| Immunoassay, Methotrexate Pre-Amendment | |
| Device, Unclassified |
3
807.92 (a)(3): Identification of the legally marketed predicate device
Performance of the ARK Methotrexate Assay was established on the Roche/Hitachi 917 analyzer in the original 510(k) (K111904).
807.92 (a)(4): Device Description
The ARK Methotrexate Assay is a homogeneous immunoassay based on competition between drug in the specimen and Methotrexate 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 coenzyme NAD functions only with the bacterial enzyme used in the assay.
The ARK Methotrexate Assay consists of reagents R1 anti-Methotrexate polyclonal antibody with substrate and R2 Methotrexate labeled with bacterial G6PDH enzyme. The ARK Methotrexate Calibrator consists of a six-level set to calibrate the assay, and the ARK Methotrexate Control consists of a six-level set used for quality control of the assay (tri-level calibration range set and tri-level high range set). The ARK Methotrexate Dilution Buffer is equivalent to zero calibrator (Calibrator A).
807.92 (a)(5): Intended Use / Indications for Use
The ARK™ Methotrexate Assay is a homogeneous enzyme immunoassay intended for the quantitative determination of methotrexate in human serum or plasma on automated clinical chemistry analyzers. The measurements obtained are used in monitoring levels of methotrexate to help ensure appropriate therapy.
Specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy should not be tested with the ARK Methotrexate Assay.
4
- Modification: The purpose of this submission is for a change in the platform analyzer used in the manufacture qualification of the ARK Methotrexate Assay from the Roche/Hitachi 917 analyzer to the Beckman Coulter AU680 analyzer.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| Characteristic | Device
ARKTM Methotrexate Assay –
Beckman Coulter AU680 | Predicate
ARKTM Methotrexate Assay
– Roche/Hitachi 917 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Intended Use | The ARKTM Methotrexate Assay is
intended for the quantitative
determination of methotrexate in human
serum or plasma on automated clinical
chemistry analyzers. | Same |
| Indications for
Use | The measurements obtained are used in
monitoring levels of methotrexate to
help ensure appropriate therapy. | Same |
| Sample | Serum or plasma | Same |
| Methodology | Homogenous enzyme immunoassay
(EIA) | Same |
| Reagent
Components | Two (2) reagent system:
Anti-Methotrexate Antibody/Substrate
Reagent (R1) containing rabbit
polyclonal antibodies to Methotrexate,
glucose-6-phosphate, nicotinamide
adenine dinucleotide, bovine serum
albumin, preservatives, and stabilizers
Enzyme Reagent (R2) containing
Methotrexate labeled with bacterial
G6PDH, buffer, bovine serum albumin,
preservatives, and stabilizers | Same |
| Platform Required | Automated clinical chemistry analyzer | Same |
| Accessory
Reagents | Calibrators (six levels) and controls (six
levels) in a synthetic matrix; Dilution
Buffer | Same |
| Testing
Environment | Routine clinical laboratory | Same |
| Reagent
Condition and
Storage | Liquid, 2-8° C | Same |
SUBSTANTIAL EQUIVALENCE COMPARATIVE CHART
5
807.92 (b)(1) and 807.92 (b)(2): Brief Description of Nonclinical and Clinical Data
Validation and verification activities were performed which included analytical performance studies to ensure that the performance of the ARK Methotrexate Assay as used on the Beckman Coulter AU680 analyzer is substantially equivalent to the performance of the assay as used on the Roche/Hitachi 917 analyzer (K111904). The following performance characteristics were evaluated:
- Limit of Blank ●
- Limit of Detection
- Limit of Quantitation
- Recovery ●
- Linearity
- Accuracy (Method Comparison)
- Precision
- . Specificity
- Cross-reactivity
- Carry-over ●
- Dilution Recovery ●
- On-board Stability .
The pre-determined Pass/Fail acceptance criteria were met for all of the above performance studies.
807.92 (b)(3): Conclusions from Nonclinical Testing
The ARK Methotrexate Assay System (including the ARK Methotrexate Calibrator, ARK Methotrexate Control and ARK Methotrexate Dilution Buffer) as applied on the Beckman Coulter AU680 automated clinical chemistry analyzer is substantially equivalent to the ARK Methotrexate Assay System on the Roche/Hitachi 917 automated clinical chemistry analyzer. The ARK Methotrexate Assay System was shown to be safe and effective for its intended use based on performance studies.
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