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Randox Creatinine

FDA 510(k)

Class II (US FDA 510(k))

510(k) K973993

by Randox Laboratories, Ltd.

Identifiers

510(k) Number
K973993 FDA 510(k)
FDA Product Code
CGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1225 FDA 510(k)
Regulation Number
862.1225 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Randox Creatinine Assay is a colorimetric enzymatic reagent used for the quantitative measurement of creatinine in biological samples. Creatinine is a byproduct of muscle metabolism, and its levels in serum, plasma, or urine are clinically significant for assessing renal function and diagnosing conditions such as chronic kidney disease. This assay employs an enzymatic method to improve sensitivity, reproducibility, and accuracy compared to traditional alkaline picrate techniques.

The assay is supplied as a liquid, ready-to-use reagent in solution form, designed for use in clinical laboratories. It is intended for single-use applications and requires no additional preparation beyond standard laboratory procedures. The device is classified under FDA 510(k) clearance (K973993) and adheres to regulatory standards for in vitro diagnostic reagents, ensuring compliance with 21 CFR Part 862.1225. Storage conditions and expiration dates are specified on the packaging to maintain reagent integrity.

Frequently asked questions

What is the Randox Creatinine Assay used for?

The Randox Creatinine Assay is designed for the quantitative measurement of creatinine in biological samples, including serum, plasma, or urine. Creatinine levels are clinically important for evaluating renal function and diagnosing conditions like chronic kidney disease. The enzymatic method enhances sensitivity and accuracy compared to older alkaline picrate techniques, ensuring reliable results for clinical decision-making.

How is the Randox Creatinine Assay supplied and prepared for use?

The assay is supplied as a ready-to-use liquid reagent in solution form, requiring no additional preparation beyond standard laboratory procedures. It is intended for single-use applications, simplifying workflow and reducing the risk of contamination or cross-reactivity between tests.

Is the Randox Creatinine Assay sterile and single-use?

Yes, the Randox Creatinine Assay is designed for single-use only, which minimizes the risk of carryover or sample contamination. While the packaging specifies sterility and storage conditions to maintain reagent integrity, the liquid reagent itself is not sterile in the traditional sense (e.g., terminally sterilized) but is formulated to prevent microbial growth during its shelf life when stored properly.

What regulatory pathway does the Randox Creatinine Assay follow?

The Randox Creatinine Assay is cleared under the FDA’s 510(k) pathway (K973993) as substantially equivalent to existing alkaline picrate-based creatinine tests. It adheres to regulatory standards outlined in 21 CFR Part 862.1225, ensuring compliance with in vitro diagnostic reagent requirements. The device is classified under the FDA’s Clinical Chemistry category and has been reviewed by the Chemistry (CH) Advisory Committee.

How should the Randox Creatinine Assay be stored?

Storage conditions and expiration dates are clearly indicated on the packaging to preserve reagent integrity. Proper storage typically involves refrigeration or adherence to temperature guidelines specified by the manufacturer, preventing degradation that could affect assay performance. Always refer to the packaging instructions for precise storage instructions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Creatinine | Reagents | Biochemistry | Randox Laboratories, Creatinine (Enzymatic) - Randox Laboratories, Creatinine assay - Randox Online Store, Creatinine assay - Randox Online Store, Solution reagent - CR series - Randox Laboratories - for clinical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Randox Laboratories, Ltd.

Sources (1)

  • FDA 510(k) K973993 24 fields · synced Oct 1, 2026