Emit-And Methotrexate Assay

• • Terminated Z-1618-2016 FDA Class II ·initiated 8 Mar 2016

  Siemens Healthcare Diagnostics confirmed that Syva Emit Methotrexate Application (DVMTX.1) for Dimension Vista System does not meet On-Board Stability claim of 20 hours. Testing using reagent at the end of the 20 hours On-Board Stability has shown that values of methotrexate for patient and quality control samples increased.

510(k) Number

K811459 ↗

FDA Product Code

LAO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• C-Reactive Protein Control

  Class II

  FDA 510(k) K821412 Active Cleared 22 Jul 1982

• Ethyl Alcohol Serum Calibrator

  Class II

  FDA 510(k) K810466 Active Cleared 6 Mar 1981

• Micro Trak Xl System

  Class I

  FDA 510(k) K921747 Active Cleared 1 Oct 1992

• Syva Solid Phase Columns System Ii

  Class I

  FDA 510(k) K861392 Active Cleared 13 Jun 1986

• Modif. of Emit Cad Disopyramide Assay

  Class II

  FDA 510(k) K833623 Active Cleared 8 Dec 1983

• Emit Auto Cortisol Assay

  Class II

  FDA 510(k) K800245 Active Cleared 3 Mar 1980

See all devices from Syva Co. →