# K073055: Dimension Enzymatic Creatinine Flex Reagent Cartridge with Model DF270

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 3, 2008 after 65 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003261 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003261: Creatinine Plus, Roche Diagnostics Corp. (2000) Summary page 1.

## Recalls of this device
- May 4, 2020 · Class II · Z-2284-2020: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
- Dec 18, 2019 · Class II · Z-1232-2020: 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 met
- Mar 17, 2016 · Class II · Z-1660-2016: 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 depre
- Jun 10, 2010 · Not classified · Z-2177-2011: Patient results may be falsely depressed or falsely elevated across the assay range.
- Sep 29, 2008 · Not classified · Z-0485-2009: Reagent may exhibit unflagged inaccurate patient sample results.

## Indications for use
The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.

Source page: https://510kreport.com/device/K073055
Methodology: https://510kreport.com/methodology