# K925668: Creatinine Meth for Use on the Dimension Clin Chem

- Pathway: 510(k) (Traditional)
- Applicant: E.I. Dupont DE Nemours & Co., Inc.
- Decided: Dec 28, 1992 after 48 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K061238: Dimension Vista Carbon Dioxide, Creatinine and Lactate Dehydrogenase Flex Reagent Cartridge (2006), 1 descendant of its own
- K132638: Dimension Creatinine (CRE2) Flex Reagent Cartridge (2014), 0 descendants of its own
- 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
- Nov 22, 2011 · Not classified · Z-0772-2012: Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and FA2237 when processing tests from a well
- Dec 27, 2010 · Not classified · Z-1729-2011: Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well that has been punctured. This issue may af

Source page: https://510kreport.com/device/K925668
Methodology: https://510kreport.com/methodology