# K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents

- Pathway: 510(k) (Traditional)
- Applicant: Seppim S.A.S.
- Decided: May 6, 2011 after 463 days
- Product code: CEO (Phosphomolybdate (Colorimetric), Inorganic Phosphorus)
- Device class: 1
- Regulation: 21 CFR 862.1580
- 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 K842280 (1984). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 1.
- K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer, Horiba Abx (2006) Summary page 3.
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP, Horiba Abx (2007) Summary page 3.
- K070249: Abx Pentra 400, Calcium CP, Creatinine CP, Phosphorus CP, Amylase CP, Urine Control L/H, Horiba Abx (2007) Summary page 7.
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H, Horiba Abx (2008) Summary page 10.
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 14.

## Indications for use
ELiTech Clinical Systems PHOSPHORUS reagent is for the quantitative in vitro diagnostic determination of inorganic phosphorus in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin 0 imbalance. ELiTech Clinical Systems URIC ACID MONO SL reagent is for the quantitative in vitro diagnostic determination of uric acid in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. ELiTech Clinical Systems UREA UV SL reagent is for the quantitative in vitro diagnostic determination of urea nitrogen in human serum and plasma on the Vital Scientific Selectra/Flexor analyzers. It is not intended for use in Point of Care settings. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. 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 Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELiTech Clinical Systems ELITROL I is a multi-para metric control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior Analyzer and the Vital Scientific Flexor Junior Analyzer. ELiTech Clinical Systems ELITROL II is a multi-parametric control serum for in vitro diagnostic use in accuracy control of quantitative ELiTech Clinical Systems methods on the Vital Scientific Selectra Junior analyzer and the Vital Scientific Flexor Junior analyzers.

Source page: https://510kreport.com/device/K100263
Methodology: https://510kreport.com/methodology