Creatinine Standard Solution Calibrator

510(k) Number

K871756 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Creatinine Standard Solution Calibrator in a clinical laboratory setting?

  The Creatinine Standard Solution Calibrator is designed to standardize and validate creatinine assays in clinical chemistry. It provides a reference solution with known concentrations of creatinine, ensuring that laboratory equipment and tests accurately measure creatinine levels in patient samples. This helps maintain precision and reliability in diagnostic results.

• How is the Creatinine Standard Solution Calibrator supplied, and is it intended for single-use or repeated use?

  The device is supplied as a liquid reagent for in vitro diagnostic use, specifically intended for single-use applications in clinical laboratories. This means each vial or container is meant to be used once before disposal, ensuring accuracy and preventing cross-contamination.

• What regulatory pathway was followed for the FDA clearance of this device, and what class does it belong to?

  The Creatinine Standard Solution Calibrator was cleared through the FDA’s 510(k) pathway, specifically under the traditional review process, and it is classified as a Class II device. The clearance number is K871756, and it was determined to be substantially equivalent to a predicate device under FDA nomenclature. The device falls under regulation number 862.1150 for secondary calibrators.

• Are there any specific storage conditions mentioned for the Creatinine Standard Solution Calibrator?

  The provided data does not specify any particular storage conditions (such as temperature or light exposure) for the Creatinine Standard Solution Calibrator. Laboratories should follow general best practices for liquid reagents, such as storing in a cool, dry place away from direct sunlight, unless manufacturer instructions specify otherwise.

• What types of laboratories or settings would typically use this calibrator?

  This calibrator is intended for use in clinical laboratories that perform creatinine assays as part of routine clinical chemistry testing. It is specifically designed for laboratories that require precise calibration of their equipment to ensure accurate measurement of creatinine levels in patient samples, which is critical for diagnosing and monitoring conditions like kidney function.