# K021897: Randox Haemoglobin A1C

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 26, 2002 after 169 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
- Jun 7, 2017 · Class II · Z-0285-2018: Randox confirmed low calibration absorbance with HbA1c, Catalog Number HA3830, Batch 414553. The reagent may not continue to meet its specific performance characteristics throughout the shelf life of 

## Indications for use
The Randox Laboratories Limited Haemoglobin A, Test Kit is an in vitro diagnostic reagent for the quantitative determination of haemoglobin AI, (HbA1,) in whole blood. The method is an immunological assay. Both the concentration of HbAl, and the concentration of total haemoglobin are measured. The reported HbAl, result is calculated as a percentage of the total haemoglobin concentration. Measurements of percentage HbA1, are effective in monitoring long-term glucose control in individuals with diabetes mellitus. This application sheet has been developed for the Hitachi 717 clinical chemistry analyser and must be used by suitably qualified laboratory personnel under appropriate clinical laboratory conditions.

Source page: https://510kreport.com/device/K021897
Methodology: https://510kreport.com/methodology