# K121366: Hemocue HBA1C 501

- Pathway: 510(k) (Special)
- Applicant: Infopia Co, Ltd.
- Decided: Sep 7, 2012 after 123 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
Longest line of descent: 4 generations back to K950727 (1995). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082275: Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023, Infopia Co, Ltd. (2010) Summary page 1.

## Most influential descendants
- K141750: Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System (2014), 0 descendants of its own

## Indications for use
The Hemocue®8 Hbal c 501 assay is an in vitro diagnostic test that quantitatively measures the percent concentration glycosylated hemoglobin in capillary or venous whole blood samples for clinical laboratory and point of care use. Measurement of percent HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. Hemocue® Hbalc 501 is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use. The test is for prescription use as an aid in the management of diabetes.

Source page: https://510kreport.com/device/K121366
Methodology: https://510kreport.com/methodology