# K133728: Dimension Vista Creatinine (CRE2) Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 24, 2014 after 49 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K860021 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061238: Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge, Dade Behring, Inc. (2006). Our reading of the summary gave K061236, FDA’s number for Flexifit HC432 Full Face Mask (Fisher & Paykel Healthcare, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Dimension Vista® Creatinine (CREA) Flex® reagent cartridge”. Summary page 3.

## Indications for use
The CRE2 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 certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Source page: https://510kreport.com/device/K133728
Methodology: https://510kreport.com/methodology