Thrombelastograph (Teg) Platelet Mapping Assay

• • Terminated Z-1298-2022 FDA Class II ·initiated 19 Apr 2022 ·on shared 510(k) K041502

  When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA % Inhibition and % Aggretagion may be displayed on TEG Manager for the affected assays.

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

510(k) Number

K041502 ↗

FDA Product Code

JOZ

Device Class

Class II

Regulation

21 CFR Part 864.5700

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Thrombelastograph

  Class II

  FDA 510(k) K904204 Active Cleared 1 Nov 1990

• Thrombelastograph Coagulation Analyzer 3000S

  Class II

  FDA 510(k) K954437 Active Cleared 30 Jan 1996

• Thrombelastograph(R)

  Class II

  FDA 510(k) K895844 Active Cleared 24 Oct 1989

• Thrombelastograph Coagulation Analyzer Teg - 5000 Series

  Class II

  FDA 510(k) K993678 Active Cleared 5 May 2000

• Thrombelastograph Coagulation Analyzer Teg-5000 Series

  Class II

  FDA 510(k) K002177 Active Cleared 14 Sep 2000

• Rapidteg Teg-Act Test

  Class II

  FDA 510(k) K062604 Active Cleared 31 Jan 2007