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510(k) K233454

ONLINE TDM Methotrexate by Roche Diagnostics Operations — Product Code LAO

K233454 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Operations for the device "ONLINE TDM Methotrexate". The FDA issued a decision of Substantially Equivalent on February 20, 2024. The device falls under product code LAO (Enzyme Immunoassay, Methotrexate), a Class U device. Roche Diagnostics Operations has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2024
Date Received
October 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Methotrexate
Device Class
Class U
Regulation Number
Review Panel
TX
Submission Type

Other clearances by Roche Diagnostics Operations

  • K241220 — Tina-quant Lipoprotein(a) Gen.2 Molarity (January 24, 2025)
  • K163633 — cobas HbA1c Test, cobas b 101 system (July 28, 2017)
  • K131366 — ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM (October 11, 2013)
  • K131029 — ACCU-CHEK AVIVA PLUS TEST STRIP (August 9, 2013)
  • K121610 — COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY (August 8, 2013)
  • K113072 — TINA-QUANT ALBUMIN GEN.2 (May 14, 2012)

Other clearances for product code LAO

  • K232017 — ARK Methotrexate II Assay (December 20, 2023)
  • K163359 — ARK Methotrexate Assay (August 18, 2017)
  • K111904 — ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, A (October 18, 2011)
  • K932615 — TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II (July 14, 1993)
  • K884744 — ACA DU PONT METHOTREXATE (MTHO) METHOD (January 30, 1989)
  • K833634 — EMIT & METHOFREXATE ASSAY (December 22, 1983)
  • K830398 — TDX METHOTREXATE (March 10, 1983)
  • K811459 — EMIT-AND METHOTREXATE ASSAY (June 9, 1981)
  • K781381 — EMIT METHATREXATE ASSAY (October 10, 1978)

FDA data resources