N Latex Cdt

• • Terminated Z-1790-2020 FDA Class II ·initiated 2 Mar 2020

  Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the HPLC method, observed to occur after 15 months based on shelf life monitoring

• • Terminated Z-2931-2018 FDA Class II ·initiated 31 May 2018

  Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT lots in comparison to the HPLC method. CDT results in absolute concentrations may be influenced by patients transferrin levels and, therefore, results are reported as ratio of CDT to total transferrin, called %CDT. As the transferrin determination with N Antiserum to Human Transferrin is not affected, the observed effect leads to calculated %CDT values that show a negative bias of approximately 15% compared to the HPLC method. This could result in a shift of weak positive patient samples into the reference range of 1.19 2.47 %CDT which was derived from a study population of healthy adults. There are no control or calibrator materials that would catch this bias.

510(k) Number

K060677 ↗

FDA Product Code

NAO

Device Class

Class I

Regulation

21 CFR Part 862.1360

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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