# K973993: Randox Creatinine

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Mar 6, 1998 after 136 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070727: Advia Chemistry Enzymatic Creatinine_2 (2007), 4 descendants of its own
- K161494: Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (2016), 2 descendants of its own
- K242685: Atellica® CH Creatinine_3 (Crea3) (2024), 1 descendant of its own
- K251058: Tru Kidney Health Test Panel; Tru Analyzer (2025), 0 descendants of its own
- K212223: Atellica CH Enzymatic Creatinine_3 (ECre3) (2021), 0 descendants of its own

## Indications for use
The Randox Laboratories Limited Creatinine Test Kit is an in vitro diagnostic reagent for the quantitative determination of creatinine in human serum and plasma. The method is based on the reaction of creatinine with picrate in an alkaline environment (Jaffe) to produce a coloured complex. Creatinine is measured primarily to assess kidney function. This test kit must‘be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K973993
Methodology: https://510kreport.com/methodology