# K830556: Creatinine

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Mar 24, 1983 after 29 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Dec 12, 2014 · Class III · Z-2773-2015: Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported 
- Dec 1, 2009 · Not classified · Z-1035-2010: An additional 10% picric acid was added to the R2 component during production.
- Dec 1, 2009 · Not classified · Z-1036-2010: An additional 10% picric acid was added to the R2 component during production.

Source page: https://510kreport.com/device/K830556
Methodology: https://510kreport.com/methodology