# K132399: Elitech Clinical Systems Creatinine Pap SL, Elical 2, Elitrol I and Elitrol II, Urine Control BI-Level

- Pathway: 510(k) (Traditional)
- Applicant: Elitechgroup
- Decided: Jan 3, 2014 after 155 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 K811832 (1981). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024098: Cobas Integra Creatinine Plus Ver.2 Assay, Roche Diagnostics Corp. (2002) Summary page 1.
- K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 1.
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 1.
- K020817: Liquichek Urine Chemistry Control, Bio-Rad Laboratories, Inc. (2002) Summary page 2.

## Indications for use
ELiTech Clinical Systems CREATININE PAP SL is intended for the quantitative in vitro diagnostic determiniation of creatinine in human serum, plasma and urine on ELiTech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use inPoint of Care settings. 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. ELITech Clinical Systems ELICAL 2 is a multi-paramnetric calibrator for in vitro diagnostic use in the calibration of quantitative ELiTech Clinical Systems methods on ELiTech Clinical Systems Selectra Pro Series Analyzers. ELITecli Clinical Systetms ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Selectra Pro Series Analyzers. ELITech Clinical Systems URINE CONTROL BI- LEVEL is a set of 2 levels of urine controls used for in vitro diagnostic in the quality control of quantitative ELITech Clinical Systems methods on ELiTech Clinical Systems Seletra Prto Series Analyzers.

Source page: https://510kreport.com/device/K132399
Methodology: https://510kreport.com/methodology