Asahi Kasei Pharma received 510(k) clearance from the US Food and Drug Administration (FDA) on October 12, 2017, for Lucica® Glycated Albumin-L, an in vitro diagnostic assay kit for glycated albumin (GA-L) formulated for the US market.

Focusing on glycated albumin as an effective marker of glycemic control for diabetes, Asahi Kasei Pharma leveraged its own original enzymes to develop glycated albumin assay kits for use with biochemical auto-analyzer. Asahi Kasei Pharma obtained approval for GA-L in Japan (2002) and in China (2005), and its marketing partners obtained approval in Korea (2013), Indonesia (2013), and Taiwan (2015), and affixed the CE Mark in Europe (2015). Submission for 510(k) clearance for Lucica® Glycated Albumin-L was made in January 2017.

The number of people with diabetes continues to increase, and the disease is known to raise the risks of heart disease, cancer, and dementia. According to the US Centers for Disease Control and Prevention (CDC), there are 30.3 million people in the US (9% of the population) with diabetes and 84.1 million (34% of the adult population aged 18 years or older) who are considered to have prediabetes. There is wide recognition of the urgent necessity of effective preventive measures.

Treatment of diabetes requires glycemic control. Various measurements are used to provide indicators, including glycated hemoglobin (HbA1c), glycated albumin, and 1,5-anhydroglucitol (1,5AG). The most commonly used measurement, HbA1c, indicates the glycemic level during the preceding two to three months. By comparison, measurement of glycated albumin provides an indication of the glycemic level of the preceding two to three weeks, a shorter term than is indicated by HbA1c. By providing an intermediate-term indicator, glycated albumin measurement is considered to be especially useful for the confirmation of shorter-term therapeutic efficacy when treatment is newly initiated and when there is a change in the treatment regimen. Glycated albumin measurement is furthermore regarded as useful in the case of pregnant women and patients with dialysis, for whom HbA1c may provide insufficient indication of glycemic level. The clinical utility of GA-L has been corroborated by various research reports.¹

The receipt of 510(k) clearance enables Asahi Kasei Pharma to launch its GA-L business in the US while reinforcing the promotion of GA-L in Japan, China, other parts of Asia, and Europe, supporting the effective treatment of diabetes and contributing to life and living for people around the world.

1. ¹ Reports of clinical utility
   1. a. It has been reported that elevated glycated albumin levels are associated with progression of the following disorders: microvascular complications (retinopathy, nephropathy), macrovascular complications (e.g., arteriosclerosis, heart diseases), diabetes risk, and complications during pregnancy.
   2. b. It has been reported that glycated albumin measurement enables hemodialysis patients to accurately monitor the control of their glycemic level.

Product outline (excerpted from 510(k) summary)

Device Name

Lucica® Glycated Albumin-L

Intended 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.

Glossary

The term “glycated albumin” refers to albumin to which glucose has bonded. The level of glycated albumin decreases when blood glucose remains low, and it increases when blood glucose remains high.

The term “510(k) clearance” refers to a premarket submission made to FDA to demonstrate that the medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed medical device (21 CFR§807.92(a)(3)6). The FDA categorizes medical devices as Class I, Class II, or Class III based on the degree of risk. Class II medical devices and certain types of Class I medical device require 510(k) clearance before they can be marketed in the US.