# K062737: Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Jun 12, 2007 after 272 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K834502: CK-Nac Reagent, Roche Diagnostic Systems, Inc. (1984) Summary page 3.
- K021229: Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244, Beckman Coulter, Inc. (2002) Summary page 3.
- K060854: Abx Pentra 400:  Lipoproteins, Horiba Abx (2006) Summary page 2.
- K954074: Aalto Scientific Liquid Cardiac Control, Aalto Scientific, Ltd. (1995) Summary page 3.
- K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688), Bio-Rad (1996) Summary page 3.

## Indications for use
Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes. ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods. ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoglobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay. Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease. The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision. The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers. The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision. The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

Source page: https://510kreport.com/device/K062737
Methodology: https://510kreport.com/methodology