# K102993: Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL

- Pathway: 510(k) (Traditional)
- Applicant: Seppim S.A.S.
- Decided: May 19, 2011 after 223 days
- Product code: CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides)
- Device class: 1
- Regulation: 21 CFR 862.1705
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933930 (1994). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060854: Abx Pentra 400:  Lipoproteins, Horiba Abx (2006) Summary page 1.
- K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 6.
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 7.

## Indications for use
ELiTech Clinical Systems TRIGLYCERIDES SL is intended for the quantitative in vitro diagnostic determination of triglycerides in human serum and plasma on ELiTech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nelphrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. ELiTech Clinical Systems CHOLESTEROL SL is intended for the quantitative in vitro diagnostic determination of cholesterol in human serum and plasma on ELITech Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. ELiTech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on the ELITech Vital Scientific Selectra/Flexor Analyzers. ELiTech Clinical Systems ELITROL I & ELITROL 11are multiparametric control sera for use in quality control of ELITech Clinical Systems methods on ELITech Vital Scientific Selectra/Flexor Analyzers.

Source page: https://510kreport.com/device/K102993
Methodology: https://510kreport.com/methodology