# K073309: Abx Pentra HBA1C WB, Calibrator, Control and Hemolysis Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Horiba Abx
- Decided: Oct 17, 2008 after 329 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- 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 K951361 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031380: Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog Number ODC3032), Olympus America, Inc. (2003) Summary page 2.
- K955087: Hemoglobin Alc (HBA1C) & Total Assays for the Technicon RA/Opera Systems in-Vitro Diagnostic Systems, Bayer Corp. (1996) Summary page 2.
- K951361: Dca 2000 System for Hemoglobin A1C, Heraeus Kulzer, Inc. (1995) Summary page 2.

## Indications for use
ABX PENTRA HBAlc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin Alc percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer Percent HbAlc measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. The ABX PENTRA HbAlc WB Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HbAlc WB method on Horiba ABX clinical chemistry analyzers. The ABX PENTRA HbAlc WE Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA HbAlc WB method. The ABX PENTRA HbAlc WB Hemolysis Reagent is an additional reagent for use in combination for the quantitative ABX PENTRA HbAlc WB method.

Source page: https://510kreport.com/device/K073309
Methodology: https://510kreport.com/methodology