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Minicap Hb A1c, Minicap Flex-Piercing, Hb A1c Capillarys Controls, Hba1c Capill…

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K133344

by Sebia

Identifiers

510(k) Number
K133344 FDA 510(k)
FDA Product Code
LCP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7470 FDA 510(k)
Regulation Number
864.7470 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Minicap Hb A1c, Minicap Flex-Piercing, and associated controls and calibrators are designed for the separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood. This device employs capillary electrophoresis in an alkaline buffer to analyze glycated hemoglobin levels, aiding in the monitoring of long-term glycemic control.

These components are intended for use with the Minicap Flex-Piercing instrument, a fully automated capillary electrophoresis system. Supplied as single-use controls and calibrators, they are regulated under the FDA 510(k) pathway and the In Vitro Diagnostic Regulation (IVDR). The device is classified as Class II and falls under the medical specialty of hematology, adhering to regulatory standards for in vitro diagnostic assays.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: MINICAP Flex Piercing, automated Capillary Electrophoresis ... - Sebia, Capillary electrophoresis system - MINICAP FLEX-PIERCING - Sebia - for ..., Minicap Hb A1c, Minicap Flex-piercing, Hb A1c Capillarys Controls ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sebia

Sources (2)

  • FDA 510(k) K133344 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026