# K102647: Elitech Clinical Systems Selectra Prom/Elical 2/Elitrol I and Elitrol II/Ast/Got 4+1 SL/Potassium, Sodium, Chloride... - Pathway: 510(k) (Traditional) - Applicant: Elitechgroup Vital Scientific BV - Decided: Mar 24, 2011 after 191 days - Product code: JGS (Electrode, Ion Specific, Sodium) - Device class: 2 - Regulation: 21 CFR 862.1665 - Recalls of this device: 4 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K781921 (1979). 24 ancestors in all. No later device cites it as a predicate yet. 0 of 25 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module), Horiba Abx (2005) Summary page 2. - K071211: Cobas C 111 Analyzer, Roche Diagnostics (2007) Summary page 2. - K060318: Hepatic Enzymes on Abx Pentra 400 Clinical Chemistry Analyzer, Horiba Abx (2006) Summary page 2. - K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera, Roche Diagnostics Corp. (2004) Summary page 2. - K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 6. - (no number) ISE Calibration kit: named in the summary without a submission number ## Recalls of this device - Jul 12, 2016 · Class III · Z-2764-2019: Software malfunction; The action being taken due to the device becoming inoperable due to software lockup. - Aug 11, 2014 · Class III · Z-0006-2015: Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached. - Jan 10, 2012 · Class II · Z-0158-2020: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. - Jan 10, 2012 · Class II · Z-0157-2020: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. ## Indications for use The ELITech Clinical system Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophotometric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidimetric assays. The second module is an electrometer used for measurement of electrolytes. For in vitro diagnostic use only. ELiTech Clinical Systems AST/GOT 4+1 SL is a reagent for the quantitative in vitro diagnostic determination of the activity of the enzyme Aspartate Amino Transferase (AST) in human serum and plasma on ELiTech Clinical Systems Selectra ProM analyzer. Aspartate Amino Transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. ISE Sodium Electrode The sodium electrode for the ELiTech Clinical Systems Selectra ProM is intended for the quantitative determination of sodium in serum and plasma. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion or other diseases involving electrolyte imbalance. SE Potassium Electrode The potassium electrode for the ELITech Clinical Systems Selectra ProM is intended for the quantitative determination of potassium in serum and plasma. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. ISE Chloride Electrode The Chloride electrode for the ELiTech Clinical Systems Selectra ProM is intended for the quantitative determination of chloride in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. ELITech Clinical Systems ELITROL I & ELITROL 11 are multiparametric control sera for in vitro diagnostic use in accuracy and precision of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra ProM analyzer equipped with ISE module. ELiTech Clinical Systems ISE Calibrators are used for the calibration of sodium (Na+), potassium (K+), and chloride (Cl-) on ELiTech Clinical Systems Selectra ProM analyzer equipped with ISE module. 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 Clinical Systems Selectra ProM analyzers. Source page: https://510kreport.com/device/K102647 Methodology: https://510kreport.com/methodology