# K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) - Pathway: 510(k) (Traditional) - Applicant: Horiba Abx - Decided: Dec 16, 2005 after 144 days - Product code: CFR (Hexokinase, Glucose) - Device class: 2 - Regulation: 21 CFR 862.1345 - Recalls of this device: 6 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 3 generations back to K933930 (1994). 12 ancestors in all. 15 later devices descend from it; 9 cite it directly. 0 of 28 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K920402: Roche Cobas Mira Plus, Roche Diagnostic Systems, Inc. (1992) Summary page 3. - K963627: (Modified Version) Integra Ion Selective Electrode (Ise) Module, Roche Diagnostic Systems, Inc. (1996) Summary page 4. - K801297: Cobas Reagent for Glucose Rapid, Roche Analytical Instruments, Inc. (1980) Summary page 4. - K033501: Modification to Calibrator for Automatic Systems (Cfas), Roche Diagnostics Corp. (2003) Summary page 4. - K041122: Precision Liquid Oxygen System, Precision Medical, Inc. (2004) Summary page 4. ## Most influential descendants - K060854: Abx Pentra 400: Lipoproteins (2006), 3 descendants of its own - K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own - K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical; Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (2012), 1 descendant of its own - K110137: Abx Pentra Enzymatic Creatinine CP, Abx Pentra Multical, Abx Pentra N Control, Abx Pentra P Control, and Abx Pentra Urin (2011), 1 descendant of its own - K193649: Yumizen C1200 Creatinine PAP (2021), 0 descendants of its own ## Recalls of this device - Nov 21, 2017 · Class II · Z-0494-2018: The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to inco - Nov 21, 2017 · Class II · Z-0493-2018: The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to inco - Jan 11, 2016 · Class II · Z-0740-2016: N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, an - Nov 13, 2014 · Class II · Z-0902-2015: HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent - Nov 21, 2013 · Class II · Z-0904-2014: Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium. - Mar 20, 2013 · Class II · Z-1141-2013: HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer ## Indications for use The ABX PENTRA 400 is a discrete photometric benchtop chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes. ABX PENTRA Glucose HK CP, Glucose PAP CP reagents with associated calibrators and controls are for quantitative in vitro diagnostic determination of glucose in serum and plasma using glucose hexokinase and glucose oxidase methods by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. The option of an I.S.E. (Ion Selective Electrode) module is intended for the quantitative determination of Sodium, Chloride, and Potassium by potentiometry using ion selective electrode with associated reference solution, calibrators and controls. Measurement of Sodium, Chloride, and Potassium are used in diagnosis and treatment diseases involving electrolyte imbalance. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers as specified in the enclosed annex. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex. Source page: https://510kreport.com/device/K052007 Methodology: https://510kreport.com/methodology