# K130014: A1C Gear System

- Pathway: 510(k) (Traditional)
- Applicant: Sakae Corporation
- Decided: Apr 4, 2014 after 457 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: 2 generations back to K951361 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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 3.

## Most influential descendants
- K142789: A1c iGear System (2014), 0 descendants of its own

## Indications for use
The A1c GEAR System is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A1c (%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 HbA1c 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/K130014
Methodology: https://510kreport.com/methodology