Bcs System

• • Terminated Z-0824-2016 FDA Class II ·initiated 14 Jan 2016

  False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.

• • Terminated Z-1867-2012 FDA Class II ·initiated 1 Dec 2010

  Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit, and the test immediately following is an APTT based clotting assay several results may be shortened.

510(k) Number

K013114 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K002080 Active Cleared 16 Nov 2000

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  Class II

  FDA 510(k) K012470 Active Cleared 28 Sep 2001

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  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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