# K051200: Hemoglobin A1C Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Aug 8, 2005 after 90 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
Teco Hemoglobin Alc Calibrators are for calibrating results in the quantitative determination of human hemoglobin Alc (HbAic) and Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin Alc (HbAic). Teco Hemoglobin Alc Reagent set is for the quantitative determination of Hemoglobin Alc (HbAlc) in human blood. The determination of HbAlc is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbAlc values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbAlc value indicates poorer glycemic control. For invitro diagnostic use only.

Source page: https://510kreport.com/device/K051200
Methodology: https://510kreport.com/methodology