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Creatinine Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003261

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K003261 FDA 510(k)
FDA Product Code
JFY 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)

Creatinine Plus is an in vitro assay for the quantitative determination of creatinine in human serum, plasma and urine on cobas c systems. It is an enzymatic method creatinine device classified under product code JFY. The device is designed for use in clinical chemistry laboratories to measure creatinine levels.

Creatinine Plus is supplied as a version 2 product and is regulated under FDA 510(k) clearance with K003261. It is classified as Class II under special controls. The device is intended for use with cobas c systems and is not specified as single-use or reusable. No information regarding sterility, MRI safety, or storage conditions is provided in the data.

Frequently asked questions

What is Creatinine Plus used for?

Creatinine Plus is an in vitro assay designed for the quantitative determination of creatinine levels in human serum, plasma, and urine. It is intended for use in clinical chemistry laboratories to measure creatinine levels using an enzymatic method on cobas c systems.

How is Creatinine Plus supplied and what are its specifications?

Creatinine Plus is supplied as a version 2 product. It is classified under product code JFY and is designed for use specifically with cobas c systems. The device is not specified as single-use or reusable in the provided information.

What is the regulatory status of Creatinine Plus?

Creatinine Plus is regulated under FDA 510(k) clearance with K003261. It is classified as Class II under special controls and was determined to be substantially equivalent. The device received FDA clearance on November 16, 2000.

Are there any specific storage conditions or sterility requirements for Creatinine Plus?

The provided device data does not include information regarding storage conditions or sterility requirements for Creatinine Plus. Users should refer to the product documentation or contact the manufacturer for specific storage and handling 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: CREP2, Creatinine plus ver.2 - Roche Diagnostics USA, CREP2, Creatinine plus ver.2 - Roche Diagnostics USA, CREATININE PLUS (K003261) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K003261 24 fields · synced Sep 27, 2026