# K061238: Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: May 25, 2006 after 22 days
- Product code: KHS (Enzymatic, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: 1 (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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010206: Dimension Enzymatic Carbonate (ECO2) Flex Method, Catalog DF137, Dade Behring, Inc. (2001) Summary page 1.
- K925668: Creatinine Meth for Use on the Dimension Clin Chem, E.I. Dupont DE Nemours & Co., Inc. (1992) Summary page 1.
- K860021: Dimension (TM) Clinical Chemistry System, E.I. Dupont DE Nemours & Co., Inc. (1986) Summary page 1.

## Most influential descendants
- K133728: Dimension Vista Creatinine (CRE2) Flex Reagent Cartridge (2014), 0 descendants of its own

## Recalls of this device
- Jul 15, 2015 · Class II · Z-2741-2015: Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to - 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemol

## Indications for use
The Dimension VistaTM Carbon Dioxide (CO2) Flex® reagent cartridge is a device intended to measure carbon dioxide in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. The Dimension VistaTM Creatinine (CREA) Flex® reagent cartridge is a device intended to measure creatinine levels in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. The Dimension VistaTM Lactate dehydrogenase (LDH) Flex® reagent cartridge is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum and plasma. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Source page: https://510kreport.com/device/K061238
Methodology: https://510kreport.com/methodology