Ultrachem Creatinine 64972 Centrifuchem

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K780514 ↗

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 clinical chemistry measurement does this device perform, and why is it important for renal function assessment?

  The Ultrachem Creatinine 64972 Centrifuchem measures creatinine levels in serum or plasma using alkaline picrate colorimetry. Creatinine is a byproduct of muscle metabolism filtered by the kidneys, so its concentration in blood is a key indicator of renal function. Elevated levels often signal impaired kidney function, making this test essential for diagnosing and monitoring conditions like chronic kidney disease or acute kidney injury.

• Is this reagent system designed for single-use or repeated use, and how should it be handled to maintain accuracy?

  The Ultrachem Creatinine 64972 Centrifuchem is supplied as a single-use reagent system, meaning each kit is intended for one analysis. To maintain accuracy, ensure the reagents are stored properly (as per manufacturer instructions) and used within their specified shelf life. Avoid contamination by handling only in a clean, controlled laboratory environment and adhering to standard aseptic techniques for in vitro diagnostics.

• What regulatory pathway was followed for FDA clearance, and what does the product code CGX signify?

  This device was cleared via the FDA 510(k) pathway under the traditional review process, with a decision of *Substantially Equivalent* (SESE) to a predicate device. The product code CGX categorizes it under *Clinical Chemistry* reagents, specifically for chemical analysis in laboratory settings. This classification aligns with its use for quantitative creatinine measurement, ensuring compliance with regulatory standards for in vitro diagnostics.

• Are there any special handling requirements for storage, such as temperature or light exposure?

  While the provided data does not specify exact storage conditions, typical alkaline picrate-based reagents like this one generally require protection from light and moisture to prevent degradation. The manufacturer’s instructions (not detailed here) should outline recommended storage temperatures—often between 2°C to 8°C (refrigerated) or room temperature, depending on the formulation. Always verify the label or accompanying documentation for precise guidance.