Ektachem Clinical Chemistry Slide C-Reactive Protein (Crp)

• • Ongoing Z-1876-2025 FDA Class II ·initiated 14 Apr 2025

  Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.

• • Ongoing Z-0535-2025 FDA Class II ·initiated 11 Oct 2024

  May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again.

• • Terminated Z-0864-2017 FDA Class III ·initiated 26 Oct 2016

  CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.

510(k) Number

K953197 ↗

FDA Product Code

DCK

Device Class

Class II

Regulation

21 CFR Part 866.5270

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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