# K082275: Clover A1C/Glycosylated Hemoglobin Monitor & Blood Glucose Monitor, Model Igm-0023

- Pathway: 510(k) (Traditional)
- Applicant: Infopia Co, Ltd.
- Decided: Jan 14, 2010 after 521 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: 3 generations back to K950727 (1995). 7 ancestors in all.
2 later devices descend 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)
- K071466: Dca Vantage, Model 5075, Siemens Medical Solutions Diagnostics (2007) Summary page 1.
- K072369: Evolution Blood Glucose Monitoring System, Hmd Biomedical, LLC (2008) Summary page 1.

## Most influential descendants
- K121366: Hemocue HBA1C 501 (2012), 1 descendant of its own
- K141750: Hemocue HBA1C 501 Glycosylated Hemoglobin Monitoring System (2014), 0 descendants of its own

## Indications for use
The CLOVER A1c™ HbA1c 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 HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use. The CLOVER A1c™ glucose assay is used for the quantitative measurement of the concentration of glucose in whole blood taken from the fingertip by healthcare professionals. The test is for prescription use as an aid in the management of diabetes. CLOVER A1c™ is for in vitro diagnostic use and is not to be used for the diagnosis or screening of diabetes or for neonatal use.

Source page: https://510kreport.com/device/K082275
Methodology: https://510kreport.com/methodology