Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2721, 195 7927

• • Terminated Z-1490-2014 FDA Class II ·initiated 29 Jan 2014

  Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.

510(k) Number

K071216 ↗

FDA Product Code

JFY

Device Class

Class II

Regulation

21 CFR Part 862.1225

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What clinical chemistry measurement does this product support, and how is it performed?

  The Vitros Chemistry Products CRSC Slides and DT Calibrator Kit are designed for the quantitative measurement of creatinine in serum or plasma samples. They utilize an enzymatic method, which is a biochemical approach to accurately determine creatinine levels. The DT Calibrator Kit provides traceable reference standards to ensure precise calibration and reliable assay performance on Vitros chemistry systems.

• Are these products single-use or reusable, and where should they be used?

  These products are supplied as single-use consumables, meaning each slide and calibrator kit is intended for one-time use only. They are specifically designed for clinical laboratory settings and are meant to be used exclusively with Vitros chemistry systems.

• How should these products be stored to maintain their sterility and performance?

  The manufacturer’s instructions must be followed for storage to preserve sterility and performance. While the exact storage conditions are not detailed in the provided data, typical single-use clinical chemistry consumables like these require protection from contamination, extreme temperatures, and moisture. Always refer to the accompanying documentation for precise storage guidelines.

• What regulatory pathway was followed for FDA clearance, and what classification does this device hold?

  The Vitros Chemistry Products CRSC Slides and DT Calibrator Kit were cleared through the FDA’s 510(k) pathway under the classification of Class II devices (device code 862.1225). The clearance number is K071216, and the submission was reviewed by the Clinical Chemistry (CH) Advisory Committee. The device is considered substantially equivalent to a predicate, as indicated by the decision code SESE.