# K031539: Hemoglobin A1C Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Pointe Scientific, Inc.,
- Decided: Aug 6, 2003 after 82 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K142664: URight Hemoglobin A1c system, FORA A1c System (2016), 0 descendants of its own
- K100547: Elitech Clinical Systems HBA1C Reagent, Elitech Clincal System HBA1C Calibrator Set, Elitech Clinical (2011), 0 descendants of its own

## Indications for use
This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K031539
Methodology: https://510kreport.com/methodology