ONLINE TDM Methotrexate
FDA 510(k) K233454 · Roche Diagnostics Operations
510(k) numberK233454
Submission
- Device name
- ONLINE TDM Methotrexate
- Applicant
- Roche Diagnostics Operations
Indianapolis, IN, US - Received
- October 20, 2023
- Decision date
- February 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LAO – Enzyme Immunoassay, Methotrexate
- Device class
- Unclassified
Other 510(k)s with product code LAO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232017 | ARK Methotrexate II AssayLAO · Traditional | Ark Diagnostics, Inc. | 12/20/2023SE |
| K163359 | ARK Methotrexate AssayLAO · Special | Ark Diagnostics, Inc. | 08/18/2017SE |
| K111904 | Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…LAO · Traditional | Ark Diagnostics, Inc. | 10/18/2011SE |
| K932615 | Tdx(R)/Tdx(R)Flx(R)Mehtotrexate IILAO · Traditional | Abbott Laboratories | 07/14/1993SE |
| K884744 | Aca du Pont Methotrexate (Mtho) MethodLAO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/30/1989SE |
| K833634 | Emit & Methofrexate AssayLAO · Traditional | Syva Co. | 12/22/1983SE |
| K830398 | TDX MethotrexateLAO · Traditional | Abbott Laboratories | 03/10/1983SE |
| K811459 | Emit-And Methotrexate AssayLAO · Traditional | Syva Co. | 06/09/1981SE |
| K781381 | Emit Methatrexate AssayLAO · Traditional | Dade Behring, Inc. | 10/10/1978SE |
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| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | 10/11/2013SE |
| K131029 | Accu-Chek Aviva Plus Test StripNBW · Special | 08/09/2013SE |
| K121610 | Cobas C 501 Tina-Quant HBA1CDX GEN.3 AssayPDJ · Traditional | 08/08/2013SE |
| K113072 | Tina-Quant Albumin GEN.2DCF · Traditional | 05/14/2012SE |
Questions and answers
When was ONLINE TDM Methotrexate cleared by the FDA?
ONLINE TDM Methotrexate (K233454) received a 510(k) decision of Substantially Equivalent on February 20, 2024, 123 days after the submission was received.
What is the product code of K233454?
The FDA product code is LAO – Enzyme Immunoassay, Methotrexate, a Unclassified device.