ARK Methotrexate Assay
K163359 · Ark Diagnostics, Inc. · LAO · Aug 18, 2017 · TX
Device Facts
| Record ID | K163359 |
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| Device Name | ARK Methotrexate Assay |
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| Applicant | Ark Diagnostics, Inc. |
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| Product Code | LAO · TX |
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| Decision Date | Aug 18, 2017 |
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| Decision | SESE |
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| Submission Type | Special |
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| Device Class | Class U |
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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.
Device Story
ARK Methotrexate Assay; homogeneous enzyme immunoassay; measures methotrexate levels in human serum/plasma; used on automated clinical chemistry analyzers; clinical laboratory setting; operated by laboratory technicians; provides quantitative concentration results; assists clinicians in therapeutic drug monitoring and overdose management; modification involves adding assay compatibility to a new cleared analyzer; fundamental scientific technology remains unchanged.
Clinical Evidence
Bench testing only. Verification and validation activities performed to confirm performance on the new analyzer platform; results demonstrate substantial equivalence to the predicate.
Technological Characteristics
Homogeneous enzyme immunoassay; liquid-stable reagents; automated clinical chemistry analyzer platform; quantitative measurement; no change to fundamental scientific technology.
Indications for Use
Indicated for the quantitative determination of methotrexate in human serum or plasma to monitor drug levels and ensure appropriate therapy. Contraindicated for specimens from patients who have received glucarpidase (carboxypeptidase G2) as a high dose methotrexate rescue therapy.
Predicate Devices
- ARK Methotrexate Assay (k111904)
Submission Summary (Full Text)
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SPECIAL 510(k): Device Modification OIR Decision Summary
To: THE FILE
RE: k163359
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the ARK Methotrexate Assay.
1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
ARK Methotraxate Assay (k111904)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
This change was to add a cleared assay to a new cleared analyzer.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use, physical characteristics, and performance studies of the ARK Methotrexate Assay.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
