# K040976: Genchem Creatinine Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Genchem, Inc.
- Decided: Dec 27, 2004 after 257 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: 1 generation back to K915077 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915077: Synchron Creatinine Triggered Test CX4,5,7,, Beckman Instruments, Inc. (1991) Summary page 1.

## Indications for use
The GenChem Creatinine Test Reagent System is intended for the quantitative determination of creatinine in serum, plasma and urine on the Beckman SYNCHRON CX3® System and as an aid in the diagnosis of renal impairment and diseases such as chronic glomerulonephritis, diabetic nephropathy, chronic interstitial nephritis and as an indicator of glomerular filtration rate.

Source page: https://510kreport.com/device/K040976
Methodology: https://510kreport.com/methodology