# K162281: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Feb 17, 2017 after 186 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: 5 generations back to K972265 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C, Sebia (2012) Summary page 6.
- K133344: Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys Calibrators, Sebia (2014) Summary page 6.

## Indications for use
The CAPI 3 Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in venous whole blood, by capillary electrophoresis in alkaline buffer (pH 9.4) with the CAPILLARYS 3 TERA instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. This test is not for screening or diagnosis of diabetes. The CAPI 3 Hb A1c kit is designed for Professional Use Only. The Multi-system Hb A1c CAPILLARY Controls (2) are designed for the migration control and quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures: - CAPILLARYS Hb A1c performed with the CAPILLARYS 2 FLEX-PIERCING automated instrument, - CAPI 3 Hb A1c performed with the CAPILLARYS 3 TERA automated instrument and, - MINICAP Hb A1c performed with the MINICAP FLEX-PIERCING automated instrument. The Hb A1c CAPILLARY Controls are designed for Professional Use Only. For In Vitro Use.

Source page: https://510kreport.com/device/K162281
Methodology: https://510kreport.com/methodology