# K974909: Synermed Creatinine Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Synermed Intl., Inc.
- Decided: Feb 24, 1998 after 55 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
The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods. Creatinine concentration is increased when the glomerutar filtration is decreased. Blood urea rises more steeply than creatinine as renal function declines; with dialysis, urea levels fall more rapidly than creatinine concentration. With severe, permanent renal impairment, urea levels continue to climb while creatinine levels tend to plateau. Serum creatinine concentration is low in subjects with relatively small muscle mass, patients with muscle disease, amputees, and cachetic patients. A serum creatinine level that would usually be considered normal does not rule out the presence of impaired renal function.

Source page: https://510kreport.com/device/K974909
Methodology: https://510kreport.com/methodology