CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Sebia
Identifiers
- 510(k) Number
- K232027 FDA 510(k)
- FDA Product Code
- GKA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7415 FDA 510(k)
- Regulation Number
- 864.7415 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CAPI 3 Neonat Hb, Capillaries 3 DBS Instrument is an automated device for Abnormal Hemoglobin Quantitation in neonatal dried blood spot (DBS) samples. It quantifies hemoglobin variants, including sickle cell and thalassemia markers, using capillary electrophoresis to separate and measure hemoglobin fractions with high precision.
This instrument is designed for use in clinical hematology laboratories and neonatal screening programs. Supplied as a reusable device with disposable capillary electrophoresis cassettes, it operates under non-sterile conditions and requires no special MRI safety considerations. Authorized under FDA 510(k) and IVDR, it adheres to regulatory standards for hematology diagnostics, with model-specific configurations for neonatal hemoglobin analysis.
Frequently asked questions
What clinical conditions does the CAPI 3 Neonat Hb help identify in newborns?
The CAPI 3 Neonat Hb is specifically designed to quantify abnormal hemoglobin variants in neonatal dried blood spot (DBS) samples, such as those associated with sickle cell disease and thalassemia. By using capillary electrophoresis, it separates and measures hemoglobin fractions with high precision, enabling early detection of these conditions in newborn screening programs.
Is the CAPI 3 Neonat Hb instrument itself sterile, or are there disposable components involved?
The CAPI 3 Neonat Hb instrument itself is a reusable device and operates under non-sterile conditions. However, it uses disposable capillary electrophoresis cassettes, which are intended for single-use per sample to maintain accuracy and hygiene.
How is the CAPI 3 Neonat Hb supplied, and what types of samples does it analyze?
The device is supplied as a reusable instrument paired with disposable cassettes for capillary electrophoresis. It is designed exclusively for analyzing neonatal dried blood spot (DBS) samples to quantify hemoglobin variants, making it ideal for clinical hematology laboratories and neonatal screening programs.
What regulatory pathways does the CAPI 3 Neonat Hb follow, and what does that mean for users?
The CAPI 3 Neonat Hb is authorized under both the FDA’s 510(k) pathway and the EU’s In Vitro Diagnostic Regulation (IVDR). This means it has undergone review by regulatory bodies to ensure compliance with safety, performance, and quality standards for hematology diagnostics, providing users with confidence in its clinical reliability.
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.
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 | K232027 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sebia
Sources (2)
- FDA 510(k) K232027 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026