Kodak Ektachem Clinical Chemistry Slides (CK-MB)

• • Ongoing Z-0770-2021 FDA Class II ·initiated 11 Dec 2020

  VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference

• 2 recalls, same reason

  • Terminated Z-1930-2020 FDA Class II ·initiated 1 Apr 2020
  • Terminated Z-1931-2020 FDA Class II ·initiated 1 Apr 2020

  The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.

• • Terminated Z-0306-2014 FDA Class II ·initiated 12 Jun 2013

  Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

510(k) Number

K861387 ↗

FDA Product Code

JHS

Device Class

Class II

Regulation

21 CFR Part 862.1215

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the primary purpose of the Kodak Ektachem CK-MB slides?

  These slides are in vitro diagnostic devices intended for the quantitative measurement of CK-MB isoenzymes within clinical chemistry samples.

• What analytical method do these slides use?

  The device utilizes a differential rate kinetic method to analyze clinical chemistry samples for the presence and concentration of CK-MB isoenzymes.

• Who is the intended user for this diagnostic device?

  This device is supplied specifically for professional use within clinical chemistry laboratory settings to ensure accurate and reliable diagnostic testing.

• What is the regulatory status of this product?

  The Kodak Ektachem Clinical Chemistry Slides (CK-MB) have received FDA 510(k) clearance under the identifier K861387, confirming they have been found substantially equivalent to predicate devices.