Olympus Apolipoprotein B Immunoturbidimetric Reagent

• • Ongoing Z-1815-2025 FDA Class III ·initiated 23 Apr 2025

  The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

510(k) Number

K952466 ↗

FDA Product Code

JHN

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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