# K080618: Direct HBA1C, Fructosamine, Glucose Oxidase Liquid

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostics, Inc.
- Decided: May 23, 2008 after 79 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is to be used for the quantitative determination of glucose oxidase in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia and of pancreatic islet cell carcinoma. This reagent set is intended for in vitro diagnostic use only. This product is to be used for the quantitative determination of hemoglobin Alc in human blood. The determination of hemoglobin Alc is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin Alc values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin AI c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only. This product is to be used for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K080618
Methodology: https://510kreport.com/methodology