Capi 3 Immunotyping, Capillarys 3 Tera, It/If Control
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Sebia
Identifiers
- 510(k) Number
- K161928 FDA 510(k)
- FDA Product Code
- CFF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5510 FDA 510(k)
- Regulation Number
- 866.5510 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CAPI 3 Immunotyping, Capillaries 3 Tera, IT/IF Control is an immunoelectrophoretic device for the qualitative detection and characterization of monoclonal proteins in human serum. It operates via capillary electrophoresis to identify immunoglobulin types (G, A, M) and is classified under Immunoglobulins (G, A, M) in regulatory nomenclature. The system supports immunotyping assays, distinguishing monoclonal components from polyclonal proteins.
This device is supplied as a kit for use with the Capillaries 3 Tera instrument, requiring conjunction with the CAPI 3 PROTEIN (E) 6 kit for protein separation into six major fractions in an alkaline buffer (pH 9.9). It is intended for in vitro diagnostic use in clinical immunology settings, with FDA 510(k) clearance (K161928) and IVDR compliance. The system is single-use per assay and must be stored under manufacturer-specified conditions to maintain integrity.
Frequently asked questions
What clinical applications does the CAPI 3 Immunotyping system support in diagnosing patient conditions?
The CAPI 3 Immunotyping system is designed for qualitative detection and characterization of monoclonal proteins in human serum, specifically identifying immunoglobulin types (G, A, M) via capillary electrophoresis. It helps distinguish monoclonal components—common in conditions like multiple myeloma or Waldenström macroglobulinemia—from polyclonal proteins, aiding in clinical immunology assessments.
How is the CAPI 3 Immunotyping kit supplied, and what other components are required for use?
The CAPI 3 Immunotyping kit is supplied as a standalone system for the Capillaries 3 Tera instrument but requires the separate CAPI 3 PROTEIN (E) 6 kit for protein separation into six major fractions using an alkaline buffer (pH 9.9). This ensures complete immunotyping workflow compatibility.
Is the CAPI 3 Immunotyping system intended for single-use or repeated use across multiple assays?
The CAPI 3 Immunotyping system is explicitly designed for single-use per assay. Each kit is not reusable, and proper disposal after use is necessary to maintain sterility and accuracy for subsequent tests.
What regulatory pathways does this device follow, and which medical specialty does it primarily serve?
The device follows both FDA 510(k) clearance (K161928) and IVDR compliance, confirming its regulatory standing. It is classified under Immunoglobulins (G, A, M) and is categorized for use in clinical immunology, aligning with the Immunology advisory committee (IM) during its FDA review.
What storage conditions must be followed to preserve the integrity of the CAPI 3 Immunotyping kit?
The kit must be stored under manufacturer-specified conditions to ensure stability and performance. While exact details are not provided, adherence to the packaging instructions (e.g., temperature, humidity, and protection from light) is critical to prevent degradation before use.
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 Immunotyping, Capillarys 3 Tera, It/If Control (K161928) — Fda ..., PDF Capi 3 Immunotyping, CAPILLARYS 3 TERA, high throughput clinical lab instrument | SEBIA
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 | K161928 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sebia
Sources (2)
- FDA 510(k) K161928 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026