Dimension Enzymatic Creatinine Flex Reagent Cartridge DF270

• • Terminated Z-2284-2020 FDA Class II ·initiated 4 May 2020

  The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

• • Terminated Z-1232-2020 FDA Class II ·initiated 18 Dec 2019

  There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.

• • Terminated Z-1660-2016 FDA Class II ·initiated 17 Mar 2016

  Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn from patients receiving N-Acetylcysteine (NAC) or Metamizole. NAC is the accepted antidote for acetaminophen toxicity and is justified in patients at signific

• • Terminated Z-2177-2011 FDA Unclassified (pre-2012) ·initiated 10 Jun 2010

  Patient results may be falsely depressed or falsely elevated across the assay range.

• • Terminated Z-0485-2009 FDA Unclassified (pre-2012) ·initiated 29 Sep 2008

  Reagent may exhibit unflagged inaccurate patient sample results.

Full name

Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270

510(k) Number

K073055 ↗

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 is the Dimension Enzymatic Creatinine Flex Reagent Cartridge DF270 used for?

  The DF270 is designed for the quantitative measurement of creatinine in human serum, plasma, or urine samples. It uses an enzymatic method involving creatinase, sarcosine oxidase, and horseradish peroxidase to generate a measurable signal, enabling accurate assessment of kidney function in clinical chemistry workflows.

• How is the DF270 supplied and what are its sterility and reuse requirements?

  The DF270 is supplied as a single-use, sterile, disposable reagent cartridge. It requires no additional sterilization and is intended for exclusive use on Dade Behring Dimension clinical chemistry systems. Due to its single-use nature, it cannot be reused or reprocessed.

• Is the DF270 compatible with all Dade Behring Dimension systems?

  No, the DF270 is designed specifically for use on Dade Behring Dimension clinical chemistry systems. While it is compatible with these systems, it is critical to follow the manufacturer’s guidelines and system-specific instructions to ensure accurate and reliable results.

• What storage conditions should be followed for the DF270?

  The DF270 must be stored according to the manufacturer’s instructions to maintain its integrity and performance. While the exact storage conditions are not detailed in the provided data, it is generally recommended to store reagent cartridges in a cool, dry place, protected from direct light and extreme temperatures, as per the accompanying documentation.

• What regulatory clearance does the DF270 hold?

  The DF270 has received FDA 510(k) clearance (K073055) and is classified as a Class II device under FDA regulation 862.1225. It is determined to be substantially equivalent to a predicate device, ensuring it meets the necessary safety and performance standards for clinical use.