# K080123: Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jul 17, 2008 after 182 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904082 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904082: Cholestech Lipid Monitoring System, Glucose Test, Cholestech Corp. (1990) Summary page 1.
- K011933: Glycosal II Hba 1C Test, Provalis Diagnostics, Ltd. (2001) Summary page 1.

## Indications for use
HbAlc- Measurement of % HbAlc is used to monitor long-term glucose control in individuals with diabetes mellitus. Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K080123
Methodology: https://510kreport.com/methodology