CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Sebia
Identifiers
- 510(k) Number
- K162281 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 CAPI 3 Hb A1c Multi-System HbA1c Capillary Controls (2) are quality control materials for human glycated hemoglobin A1c (HbA1c) quantification. These controls are designed for use with SEBIA capillary electrophoresis procedures, including the CAPILLARYS HbA1c and CAPI 3 HbA1c assays performed on automated instruments like the CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA.
These controls are supplied as lyophilized vials requiring reconstitution with distilled or deionized water as specified in the package insert. They are intended for migration and quality control in clinical hematology settings, adhering to IVDR and FDA 510(k) regulatory standards. The controls are single-use and must be stored according to manufacturer instructions to ensure accuracy and reliability in HbA1c measurement.
Frequently asked questions
What clinical setting or laboratory workflows are these controls specifically designed to support?
These controls are designed for migration and quality control in clinical hematology settings, specifically for use with SEBIA’s capillary electrophoresis procedures. They are intended to ensure accuracy and reliability when performing the CAPILLARYS HbA1c and CAPI 3 HbA1c assays on automated instruments like the CAPILLARYS 2 FLEX-PIERCING and CAPILLARYS 3 TERA. They help validate HbA1c quantification workflows in laboratories where these systems are deployed.
How should I prepare the controls before use, and what type of water should I use?
The controls are supplied as lyophilized vials that require reconstitution with distilled or deionized water. The exact procedure for reconstitution is detailed in the package insert provided by SEBIA. It’s important to follow these instructions precisely to ensure the controls function correctly and provide accurate HbA1c measurements.
Are these controls meant for single-use only, and if so, what happens if they’re reused?
Yes, these controls are explicitly labeled as single-use. Reusing them could compromise the accuracy and reliability of HbA1c measurements, as the integrity of the lyophilized material may be compromised after reconstitution. Reuse is not recommended and could lead to inaccurate results, potentially affecting patient care.
What regulatory pathways have these controls undergone, and how does that affect their use in my lab?
The controls have been authorized through both the FDA’s 510(k) pathway and the EU’s In Vitro Diagnostic Regulation (IVDR). This means they meet the necessary standards for quality control materials in clinical settings where HbA1c testing is performed, ensuring compliance with regulatory requirements in both the U.S. and EU markets. Their authorization does not imply an indication but confirms their suitability for use in validated laboratory workflows.
How should I store these controls to maintain their accuracy and shelf life?
Storage instructions are provided by SEBIA, but generally, lyophilized controls like these should be stored in a cool, dry place, protected from light and moisture. It’s important to follow the manufacturer’s specific guidelines to preserve their stability and ensure they remain effective for their intended use in HbA1c quantification. Always check the packaging for any additional storage recommendations.
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: CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2), PDF Re: K162281 Trade/Device Name: CAPI 3 Hb A1c, PDF CAPI 3 Hb A1c, CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) - BEUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K162281 | Class II | Active |
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Manufacturer
- Manufacturer
- Sebia
Sources (2)
- FDA 510(k) K162281 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026