# K023407: Atac Pak Creatinine Reagent and Atac Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Elan Diagnostics
- Decided: Feb 14, 2003 after 127 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. The FDA summary names its predicate without a number.
- (no number) Beckman Synchron CX Creatinine Reagent, product no. 443340: named in the summary without a submission number

## Indications for use
The ATAC Creatinine Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. This reagent is intended to be used by trained personnel in a professional setting and is not intended for home use.

Source page: https://510kreport.com/device/K023407
Methodology: https://510kreport.com/methodology