Delfia (Tm) Hfsh Kit

• • Terminated Z-0779-2017 FDA Class III ·initiated 16 Nov 2016

  A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.

510(k) Number

K862043 ↗

FDA Product Code

CGJ

Device Class

Class I

Regulation

21 CFR Part 862.1300

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• Engstom Edith

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