# K060434: Abx Pentra Albumin CP, Abx Pentra Micro-Albumin CP, Abx Pentra Total Protein CP, Abx Pentra Multical

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Jun 5, 2007 after 469 days
- Product code: CIX (Bromcresol Green Dye-Binding, Albumin)
- Device class: 2
- Regulation: 21 CFR 862.1035
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K896230 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896235: Cobas Ready Albumin Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 2.
- K903123: Raichem (TM) Spia (TM) Microalbulmin Reagent, Reagents Applications, Inc. (1990) Summary page 2.
- K896230: Cobas Ready Total Protein Reagent, Roche Diagnostic Systems, Inc. (1990) Summary page 2.

## Most influential descendants
- K191245: Yumizen C1200 ALP, Yumizen C1200 Albumin (2019), 0 descendants of its own

## Indications for use
Proteins 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 Albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative determination of Albumin in serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. ABX PENTRA Total Protein CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Total Proteins in serum and plasma by colorimetry. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. ABX PENTRA Micro-albumin CP reagent, with associated calibrators and controls, is a diagnostic reagent for quantitative in-vitro determination of Albumin in urine (pALB) at low concentration by immunoturbidimetric assay. Measurements of albumin aids in the diagnosis of diabetic nephritis and other kidney and intestinal diseases. The ABX PENTRA p-Alb Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Micro-albumin CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA p-Alb Control L/H is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA Micro-albumin CP method. 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/K060434
Methodology: https://510kreport.com/methodology