Modification to N Protein Standard Sl

• • Terminated Z-0190-2018 FDA Class II ·initiated 5 Jun 2017 ·via K012470, on the same 510(k)

  Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein Controls SL for Ceruloplasmin are similarly biased. --- The affected standards and controls for the affected lots were incorrectly value assigned, which led to a lower result compared to correctly assigned standards. Note: N Antiserum to Human Ceruloplasmin (REF OUIE) works as intended. --- Siemens investigation indicated that N Protein Standard SL and corresponding N/T Protein Control SL (Levels Low, Mid and High) are inaccurately assigned for Ceruloplasmin.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K012470 ↗

FDA Product Code

JIX

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Apolipoprotein Control Serum Chd, Model Ouph

  Class I

  FDA 510(k) K993310 Active Cleared 30 Nov 1999

• Dade Tru-Liquid Cardiac Control

  Class I

  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

  FDA 510(k) K033487 Active Cleared 24 Dec 2003

• Behring Coagulation System, Model BCS

  Class II

  FDA 510(k) K002080 Active Cleared 16 Nov 2000

• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

• Microscan Synergies Plus Gram Negative Mic/Combo Panels with Moxifloxacin (0.004-16UG/Ml)

  Class II

  FDA 510(k) K023541 Active Cleared 13 Dec 2002

See all devices from Dade Behring, Inc. →