Enzyme Immunoassay, Methotrexate
Enzyme immunoassay for methotrexate is a laboratory test method used to measure serum levels of methotrexate, a chemotherapy and immunosuppressive agent requiring careful monitoring due to its narrow therapeutic window. This device is currently unclassified by the FDA, meaning it has not been assigned to Class 1, 2, or 3 and its regulatory pathway has not been fully determined. The product code is LAO, with no regulation number assigned and no medical specialty designation recorded. No special flags such as implant, life sustaining, or third-party review eligibility apply.
Basic Information
- Product Code
- LAO
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K233454 | ONLINE TDM Methotrexate | Feb 20, 2024 | Substantially Equivalent | Roche Diagnostics Operations |
| K232017 | ARK Methotrexate II Assay | Dec 20, 2023 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K163359 | ARK Methotrexate Assay | Aug 18, 2017 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K111904 | ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN | Oct 18, 2011 | Substantially Equivalent | Ark Diagnostics, Inc. |
| K932615 | TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II | Jul 14, 1993 | Substantially Equivalent | Abbott Laboratories |
| K884744 | ACA DU PONT METHOTREXATE (MTHO) METHOD | Jan 30, 1989 | Substantially Equivalent | E.I. Dupont DE Nemours & Co., Inc. |
| K833634 | EMIT & METHOFREXATE ASSAY | Dec 22, 1983 | Substantially Equivalent | Syva Co. |
| K830398 | TDX METHOTREXATE | Mar 10, 1983 | Substantially Equivalent | Abbott Laboratories |
| K811459 | EMIT-AND METHOTREXATE ASSAY | Jun 09, 1981 | Substantially Equivalent | Syva Co. |
| K781381 | EMIT METHATREXATE ASSAY | Oct 10, 1978 | Substantially Equivalent | Dade Behring, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.