# K090330: Dimension Vista Enzymatic Creatinine Flex Reagent Cartridge, and Enzymatic Creatinine Calibrator, Models K1270, KC270

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: May 22, 2009 after 101 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 K860021 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 2.
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 2.

## Recalls of this device
- May 4, 2020 · Class II · Z-2285-2020: 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-1233-2020: 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-1664-2016: 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-2154-2011: Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range.
- Feb 12, 2010 · Not classified · Z-2419-2010: The ECREA test results may be falsely elevated or depressed.

## Indications for use
The ECREA method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma and urine on the Dimension Vista® 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. The ECREA CAL is an in vitro diagnostic product for the calibration of the Enzymatic Creatinine (ECREA) method on the Dimension Vista® System.

Source page: https://510kreport.com/device/K090330
Methodology: https://510kreport.com/methodology