# K023763: Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 13, 2003 after 66 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K042193: Diazyme Glycated Serum Protein Enzymatic Assay Kit (2004), 1 descendant of its own
- K170147: Lucica Glycated Albumin-L (2017), 0 descendants of its own
- K131307: Advia Chemistry Fructosamine Assay, Advia Chemistry Fructosamine Calibrator (2014), 0 descendants of its own

## Recalls of this device
- Dec 3, 2018 · Class II · Z-1016-2019: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and control
- Dec 3, 2018 · Class II · Z-1017-2019: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and control
- Dec 3, 2018 · Class II · Z-1018-2019: The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and control

## Indications for use
The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma. Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks. For calibration of the Fructosamine assay. To monitor the performance of the Fructosamine assay.

Source page: https://510kreport.com/device/K023763
Methodology: https://510kreport.com/methodology