# K053308: Abx Micros CRP 200, Option IM

- Pathway: 510(k) (Special)
- Applicant: Horiba Abx
- Decided: Dec 29, 2005 after 31 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002646 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002646: Abx Micros CRP, Abx Diagnostics (2000) Summary page 2.

## Recalls of this device
- Feb 14, 2014 · Class II · Z-1173-2014: HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Informatio

## Indications for use
The ABX MICROS CRP 200 is an oper tube, automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood & plasma specimens. The device operates in complete blood count (CBC) mode or in CBC & C-reactive protein (CRP) mode. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders. The MICROS CRP 200 may be coupled, on option, with a information management (iM)system. The ABX CRP STD is intended to be used for the calibration of the ABX CRP REA reagent on the ABX MICROS CRP 200 hematology analyzer for quantitative determination of C-reactive protein in human whole blood or plasma serum. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders. The ABX CRP TROL I & III are intended to be used for the control of the ABX CRP REA reagent on the ABX MICROS CRP 200 hematology analyzer for quantitative determination of C-reactive protein in human whole blood or plasma serum. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders. The ASX CRP REA is a quantitative assay for use with the ABX MICROS CRP 200 hematology analyzer for the determination of C-reactive protein in human whole blood or plasma serum. Measurement of conventional CRP aids in the evaluation of infection, tissue injury and therapy & monitoring of inflammatory disorders.

Source page: https://510kreport.com/device/K053308
Methodology: https://510kreport.com/methodology