# K083809: Creatinine

- Pathway: 510(k) (Special)
- Applicant: Abbott Laboratories
- Decided: Apr 7, 2009 after 106 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 K941837 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K061193: Creatinine, Abbott Laboratories, Inc. (2006) Summary page 2.
- K941837: Roche Reagent for Creatinine, Roche Diagnostic Systems, Inc. (1994) Summary page 2.

## Most influential descendants
- K210452: Creatinine2 (2022), 0 descendants of its own

## Indications for use
A creatinine test system 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.

Source page: https://510kreport.com/device/K083809
Methodology: https://510kreport.com/methodology