# K111128: Labonacheck A1C

- Pathway: 510(k) (Traditional)
- Applicant: Ceragem International, Inc.
- Decided: Sep 13, 2012 after 511 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: 1 generation back to K993131 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993131: Nycocard HBA1C Glycosylated Hemoglobin Assay, Primus, Inc. (2000) Summary page 1.

## Indications for use
The LabonaCheckTM A Ic is intended for the quantitative measurement of glycated hemoglobin in venous whole blood and capillary fingerstick samples. This device is intended for multiple patient, professional use. Measurement of percent glycated hemoglobin (HbAl c) is effective in monitoring long-term glucose control in individuals with diabetes mellitus by using the LabonaCheckTM Alc. Only auto-disabling, single use lancing devices should be used with this system.

Source page: https://510kreport.com/device/K111128
Methodology: https://510kreport.com/methodology