# K142789: A1c iGear System

- Pathway: 510(k) (Traditional)
- Applicant: Sakae Corporation
- Decided: Dec 16, 2014 after 81 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 K951361 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130014: A1C Gear System, Sakae Corporation (2014) Summary page 4.

## Indications for use
The Alc iGear is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin Alc (%HbA1c) from finger-stick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbAlc is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

Source page: https://510kreport.com/device/K142789
Methodology: https://510kreport.com/methodology