Kodak Ektachem Clinical Chemistry Slides (Crea)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K861819 ↗

FDA Product Code

CGX

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary use of the Kodak Ektachem Clinical Chemistry Slides (Crea) in a clinical setting?

  These slides are designed for quantitative measurement of creatinine levels in serum or plasma, which is a critical marker for assessing kidney function. The colorimetric analysis method used provides a reliable way to determine these levels in clinical laboratories.

• Are the Kodak Ektachem Clinical Chemistry Slides (Crea) intended for single-use or repeated use?

  The slides are explicitly labeled as single-use consumables, meaning each slide should only be used once for a single test. This ensures accuracy and prevents contamination or degradation of results.

• What storage conditions should be followed for the Kodak Ektachem Clinical Chemistry Slides (Crea)?

  Storage conditions and expiration dates are detailed on the packaging, so it’s important to follow those instructions precisely. Typically, reagent slides like these require protection from moisture, extreme temperatures, and direct light to maintain their integrity and accuracy.

• How were these slides approved by the FDA, and what does that mean for their use?

  The slides received FDA 510(k) clearance under the Traditional pathway in 1986, meaning they were deemed *substantially equivalent* to a legally marketed device already on the market. This approval pathway confirms their compliance with FDA regulations for Class II devices (21 CFR 862.1225) and allows them to be legally used in clinical laboratories for creatinine testing.

• Are the Kodak Ektachem Clinical Chemistry Slides (Crea) sterile, and if not, what precautions should be taken?

  The slides are explicitly labeled as *non-sterile*, so they should not be used for procedures requiring sterile conditions. Since they are intended for in vitro diagnostic use in clinical laboratories, standard laboratory hygiene practices—such as proper handling, contamination control, and adherence to manufacturer guidelines—should be followed to ensure accurate and safe testing.