Kodak Ektachem DT Slides (Alb)

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

510(k) Number

K913195 ↗

FDA Product Code

CIX

Device Class

Class II

Regulation

21 CFR Part 862.1035

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Eastman Kodak Company →

• What is the primary use of the Kodak Ektachem DT Slides (Alb) in a clinical setting?

  The Kodak Ektachem DT Slides (Alb) are designed specifically for the quantitative measurement of albumin levels in serum or plasma samples. They utilize a bromcresol green dye-binding assay to provide accurate diagnostic results, making them suitable for clinical chemistry laboratories to support patient monitoring and diagnosis.

• Are these slides intended for single-use or can they be reused?

  These slides are explicitly labeled as single-use reagents. Reusing them could compromise accuracy and safety, so they must be discarded after one use as part of the intended design for the Kodak Ektachem DT System.

• How should the Kodak Ektachem DT Slides (Alb) be stored, and what does the manufacturer recommend?

  Storage instructions are detailed in the accompanying documentation provided by Eastman Kodak Company. While the exact conditions are not specified here, proper storage is critical to maintaining the slides' performance within the Kodak Ektachem DT System. Always follow the manufacturer’s guidelines to ensure reliability.

• What regulatory pathway was followed for FDA clearance of these slides?

  The Kodak Ektachem DT Slides (Alb) received FDA clearance through a 510(k) submission, classified under Traditional clearance type. The device was determined to be Substantially Equivalent (SESE) to a predicate, and the review was conducted by the Clinical Chemistry (CH) Advisory Committee. The clearance number is K913195, and the device falls under Class II regulatory classification (regulation number 862.1035).

• Are these slides sterile, and if not, what precautions should be taken during handling?

  The slides are non-sterile reagents, meaning they are not intended for sterile procedures. Since they are used with serum or plasma samples (which are typically sterile), standard laboratory aseptic techniques should be followed during handling to prevent contamination of the sample or the testing environment.