# K053411: Dri Hemoglobin A1C Assay and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Feb 3, 2006 after 58 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
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. The FDA summary names its predicate without a number.
- (no number) Tosoh G7 Automated High Performance Liquid Chromatography (HPLC) Analyzer: HbAlc Variant Analysis Mode: named in the summary without a submission number

## Indications for use
The DRI® Hemoglobin Alc Assay is an in vitro reagent system for the quantitative determination of Hemoglobin Alc in human whole blood using automated clinical chemistry analyzers. It is intended to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus. The DRI® Hemoglobin Alc Calibrators are intended for use in thu calibration of the DRI® Hemoglobin Alc Assay in human whole blood.

Source page: https://510kreport.com/device/K053411
Methodology: https://510kreport.com/methodology