# K060854: Abx Pentra 400:  Lipoproteins

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Aug 24, 2006 after 148 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K933930 (1994). 17 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941573: Roche Reagent, Roche Diagnostic Systems, Inc. (1994) Summary page 3.
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator, Genzyme Corp. (2002) Summary page 3.
- K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set, Genzyme Corp. (1997) Summary page 3.
- K893973: Roche Reagent for Triglycerides, Roche Diagnostic Systems, Inc. (1989) Summary page 3.
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module), Horiba Abx (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K091573: ABX PENTRA LDL Cal. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K103747: Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G Calibrator, Elitrol II & Elitech Sys (2011), 0 descendants of its own
- K102993: Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL (2011), 0 descendants of its own
- K062737: Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer (2007), 0 descendants of its own

## Recalls of this device
- Jan 11, 2016 · Class II · Z-0742-2016: 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
- Jan 11, 2016 · Class II · Z-0738-2016: 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

## Indications for use
ABX PENTRA Cholesterol CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinder's reaction). ABX PENTRA HDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of High Density Lipoprotein Cholesterol (HDL-C) in human serum and plasma based on an enzymatic assay with accelerator selective detergent methodology. ABX PENTRA LDL Direct CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Low Density Lipoprotein Cholesterol (LDL-C) in human serum and plasma based on an enzymatic colorimetric assay. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. ABX PENTRA Triglycerides CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of triglycerides in human serum and plasma based on an enzymatic calorimetric assay. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. The ABX PENTRA HDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HDL Direct CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA LDL Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA LDL Direct CP method on Horiba ABX clinical chemistry analyzers.

Source page: https://510kreport.com/device/K060854
Methodology: https://510kreport.com/methodology