# K161533: A1C EZ Glycohemoglobin Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Biohermes Co., Ltd.
- Decided: Jun 16, 2017 after 379 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 K033847 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec, Bayer Healthcare, LLC (2009) Summary page 4.

## Indications for use
A1C EZ Glycohemoglobin Analysis System is an in vitro diagnostic test used to quantitatively measure the percent glycohemoglobin A1c or glycohemoglobin A1c fraction mmol/mol in venous whole blood samples. This system is intended for multiple patient use to monitor long term glycemic control in individuals previously diagnosed with diabetes. This test is not to be used for screening or diagnosis of diabetes or for neonatal use. The A1C EZ Glycohemoglobin Analysis System is intended for professional use in clinical laboratories only.

Source page: https://510kreport.com/device/K161533
Methodology: https://510kreport.com/methodology