# K170147: Lucica Glycated Albumin-L

- Pathway: 510(k) (Traditional)
- Applicant: Asahi Kasei Pharma Corporation
- Decided: Oct 12, 2017 after 268 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 K023763 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023763: Randox Fructosamine, Fructosamine Calibrator, Fructosamine Controls, Randox Laboratories, Ltd. (2003) Summary page 5.

## Indications for use
The Lucica® Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K170147
Methodology: https://510kreport.com/methodology