# K061138: Abx Pentra 400 : CRP

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Sep 29, 2006 after 158 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- 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 K022486 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023828: K-Assay C-Reactive Protein (3), K-Assay CRP Multi-Calibrator D, K-Assay CRP Multi-Calibrator E, K-Assay CRP Multi-Calibr, Kamiya Biomedical Co. (2003) Summary page 2.
- K022486: K-Assay HS-CRP Controls, Kamiya Biomedical Co. (2002) Summary page 2.

## Indications for use
CRP reagent, with associated calibrators and controls, are intended for use on ABX -. ,PE!Z Jmgc,¢_c' sAnalyzer to measure C-reactive Protein analyte. The ABX PENTRA CRP Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA CRP CP method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA Low CRP Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CRP CP method. ABX PENTRA CRP CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the C-reactive protein in human serum and plasma based on an immunoturbidimetric assay. The ABX PENTRA Immuno I Control L/H is for use in quality control by monitoring accuracy and precision for CRP. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissue.

Source page: https://510kreport.com/device/K061138
Methodology: https://510kreport.com/methodology