# K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Dec 6, 2012 after 143 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 K972265 (1997). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071132: G8 Automated HPLC Analyzer, Model HLC-723 G8, Tosoh Bioscience, Inc. (2008) Summary page 4.
- K021484: Hemoglobin A1C Control, Canterbury Scientific, Ltd. (2002) Summary page 8.

## Most influential descendants
- K133344: Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys Calibrators (2014), 1 descendant of its own
- K162281: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (2017), 0 descendants of its own

## Indications for use
The CAPILLARYS Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 2 FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. The CAPILLARYS Hb A1c kit is designed for Professional Use Only. The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only. The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with CAPILLARYS Hb A1c electrophoresis procedure performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument for capillary electrophoresis. The Hb A1c CAPILLARY Controls are designed for Professional Use Only.

Source page: https://510kreport.com/device/K122101
Methodology: https://510kreport.com/methodology