# K120497: Easyra Hbalc Regent Easycal HBLC Calibrator Easyqc Hbalc Material

- Pathway: 510(k) (Traditional)
- Applicant: Medica Corp.
- Decided: May 14, 2012 after 83 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Apr 11, 2017 · Class II · Z-1267-2018: Patient results determined using this calibrator lot might deviate up to 20%. Controls might not indicate false values.

## Indications for use
The EasyRA HbAlc Reagent kit is intended for use in the quantitative in-vitro diagnostic determination of hemoglobin Aic (HbAlc) in human whole blood using the EasyRA clinical chemistry analyzer. HbAlc measurements are used for the monitoring of long term blood glucose control in diabetic patients. The EasyCAL HbAlc calibrator is used for calibrating the HbAlc on the EasyRA clinical chemistry analyzer when used in conjunction with EasyRA HbAl c Reagent. The HbAl c calibrator is used to establish points of reference that are used in the determination of values in the measurement of HbAlc in human whole blood. The EasyOC HbAlc OC Materials are intended to use as quality control material for the HbAlc immunoturbidimetric assay, using EasyRA HbAlc Reagent and EasyCAL HbAlc calibrator on the EasyRA clinical chemistry analyzer.

Source page: https://510kreport.com/device/K120497
Methodology: https://510kreport.com/methodology