# K983937: Dual Vial Creatinine Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Intersect Systems, Inc.
- Decided: Jan 6, 1999 after 62 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.
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A creatinine test system is an in vitro device intended to measure creatinine quantitatively in serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.

Source page: https://510kreport.com/device/K983937
Methodology: https://510kreport.com/methodology