Human Igm Liquid Reagent Kit for Use on the Spaplus Analyzer

• • Terminated Z-0604-2019 FDA Class II ·initiated 6 Nov 2018

  Firm is offering advice to customers experiencing challenges when validating the calibration curve of the IgM kits. This is indicated by kit control values reporting outside the specified ranges.

• • Terminated Z-0477-2019 FDA Class II ·initiated 25 Jul 2018

  After running the calibration curve, the recovery of the IgM kit control results decrease demonstrating a reduction in accuracy within the same day; control results may be out of range one day after running the assay calibration curve. Samples have been shown to be similarly affected.

510(k) Number

K082129 ↗

FDA Product Code

CFN

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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