# K062105: Diazyme Creatinine Liquid Reagents Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Apr 23, 2007 after 273 days
- Product code: JFY (Enzymatic Method, 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: 3 generations back to K002852 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003261: Creatinine Plus, Roche Diagnostics Corp. (2000) Summary page 1.
- K063206: Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High, Dade Behring, Inc. (2006). Cleared while this submission was under review Summary page 1.

## Indications for use
Diazyme Creatinine Liquid Reagents Assay, in conjunction with Diazyme Creatinine Calibrator, is intended for the quantitative determination of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and' as a calculation basis for measuring other urine analytes. For in vitro diagnostic use only. Diazyme Creatinine Control is an assayed QC material for use in quantitative in vitro diagnostic determination of creatinine in human serum and urine. It is intended as a reference sample for monitoring the Diazyme Creatinine Liquid Reagents Assay for gross systematic errors. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K062105
Methodology: https://510kreport.com/methodology