# K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer - Pathway: 510(k) (Traditional) - Applicant: Horiba Abx - Decided: Jul 21, 2006 after 176 days - Product code: CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes) - Device class: 2 - Regulation: 21 CFR 862.1050 - Recalls of this device: 2 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K842280 (1984). 16 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 18 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K801242: Cobas Reagent for Alkaline Phosphatase, Roche Analytical Instruments, Inc. (1980) Summary page 3. - K883453: Roche Reagent for Calcium, Roche Diagnostic Systems, Inc. (1988) Summary page 3. - K031879: Cobas Integra Carbon Dioxide Assay, Roche Diagnostics Corp. (2003) Summary page 3. - K941837: Roche Reagent for Creatinine, Roche Diagnostic Systems, Inc. (1994) Summary page 3. - K864819: Raichem (TM)Serum Iron and Tibc Reagents, Reagents Applications, Inc. (1987) Summary page 3. - K901758: Roche Reagent for Magnesium, Roche Diagnostic Systems, Inc. (1990) Summary page 3. - K883962: Roche Reagent for Inorganic Phosphorus, Roche Diagnostic Systems, Inc. (1988) Summary page 3. - K954000: Roche Reagent for Bun, Roche Diagnostic Systems, Inc. (1995) Summary page 3. - K922762: Roche Reagent for Uric Acid--Modification, Roche Diagnostic Systems, Inc. (1992) Summary page 3. - K891475: Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3, Bio-Rad (1989) Summary page 3. ## Most influential descendants - K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents (2011), 0 descendants of its own ## Recalls of this device - Oct 22, 2021 · Class II · Z-1140-2022: Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be pr - Aug 11, 2014 · Class II · Z-2692-2014: Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the ## Indications for use General Chemistries reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure a variety of analytes. ABX PENTRA ALP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitrophenylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ABX PENTRA Calcium CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of calcium in human serum and plasma based on a photometric test using orthocresolphtalein complexone. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). ABX PENTRA C02 RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of carbon dioxide in human serum and plasma based on an enzymatic test using phosphoenolpyruvate (PEP), phosphorenolpyruvate carboxylase (PEPC) and an analog of NADH. Bicarbonate/carbon measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. ABX PENTRA Creatinine CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of creatinine in human serum and plasma based on a kinetic method using alkaline picrate (Jaff6 method). 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. ABX PENTRA Iron OIP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of iron (non-heme) in human serum and plasma based on a photometric test (Ferene method). Iron (non-heme) measurements are used in the diagnosis and treatment of diseases such as iron deficiency anemia and hemochromatosis. ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium). ABX PENTRA Phosphorus OP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of phosphorus in human serum and plasma based on a UV method using phosphomolybdate. Measurement of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. ABX PENTRA Urea CR reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of urea / urea nitrogen (an end-product of nitrogen metabolism) in human serum and plasma based on an enzymatic UV test using urease and glutamate dehydrogenase. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. ABX PENTRA Uric Acid CR reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of uric acid in human serum and plasma based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method). 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. The ABX PENTRA, CO2 Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CO2 RTU method on Horiba ABX clinical chemistry analyzers as specified on the vial. The ABX PENTRA CO 2 Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CO2 RTU method as specified in the enclosed annex. Source page: https://510kreport.com/device/K060205 Methodology: https://510kreport.com/methodology