# K133344: Minicap HB A1C, Minicap Flex-Piercing, HB A1C Capillarys Controls, HBA1C Capillarys Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Mar 28, 2014 after 149 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: 4 generations back to K972265 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites 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)
- K122101: Capillarys Hemoglobin HBA1C Capillarys 2 Flex Piercing Capillarys HBA1C Controls Capillarys HBA1C C, Sebia (2012) Summary page 2.

## Most influential descendants
- K162281: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (2017), 0 descendants of its own

## Indications for use
The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP Hb A1c kit with the MINICAP FLEX-PIERCING automated instrument. The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only. For In Vitro Diagnostic Use. The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP Hb A1c kit with the MINICAP FLEX-PIERCING automated instrument. The Hb A1c CAPILLARY Controls are designed for Professional Use Only. For In Vitro Diagnostic Use. The MINICAP 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 with the MINICAP FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Results are provided in IFCC (mmol/mol) and NGSP (%Hb A1c) units. The MINICAP Hb A1c kit is designed for Professional Use Only. For In Vitro Use.

Source page: https://510kreport.com/device/K133344
Methodology: https://510kreport.com/methodology