ACS:180 and Advia Centaur Ipth Immunoassay

• • Terminated Z-0173-2014 FDA Class III ·initiated 16 Aug 2013 ·on shared 510(k) K020217

  PTH Calibrator packaged with only high calibrator.

• 2 recalls, same reason

  • Terminated Z-1515-2013 FDA Class II ·initiated 14 May 2013 ·on shared 510(k) K020217
  • Terminated Z-1514-2013 FDA Class II ·initiated 14 May 2013 ·on shared 510(k) K020217

  iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability

• • Terminated Z-1186-2012 FDA Unclassified (pre-2012) ·initiated 3 Oct 2008 ·on shared 510(k) K020217

  Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K020217 ↗

FDA Product Code

JJX

Device Class

Class I

Regulation

21 CFR Part 862.1660

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Salicylate Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K020794 Active Cleared 11 Jul 2002

• Bayer Special Chemistry Controls

  Class I

  FDA 510(k) K033379 Active Cleared 19 Dec 2003

• Ammonia Assay for the Advia 1650

  Class I

  FDA 510(k) K023841 Active Cleared 24 Dec 2002

• Uric Acid Assay for the Advia Integrated Modular System

  Class I

  FDA 510(k) K022096 Active Cleared 18 Mar 2003

• Bayer Special Chemistry Calibrators

  Class II

  FDA 510(k) K033380 Active Cleared 16 Dec 2003

• Ca 15-3 Assay for the Advia Integrated Modular System

  Class II

  FDA 510(k) K022178 Active Cleared 12 Nov 2002

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