# K031296: Liqui-Heme Glyco A1C Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biodiagnostic Intl
- Decided: Oct 15, 2004 after 541 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
The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin Alc Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin Al c (HbAl c) in the human whole blood. The method is an immunological assay. Both the concentration of HbAl c and the concentration of the total hemoglobin are measured. The reported HbAlc result is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbAl c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application sheet has been developed for the Hitachi instrument of clinical chemistry analyzer and must be used by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel(Human) Low and High controls, which are optional.

Source page: https://510kreport.com/device/K031296
Methodology: https://510kreport.com/methodology