Autodelfia Neonatal IRT Kit, Model B005-112
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Wallac Oy
Identifiers
- 510(k) Number
- K003668 FDA 510(k)
- FDA Product Code
- CGZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1170 FDA 510(k)
- Regulation Number
- 862.1170 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Autodelfia Neonatal IRT Kit, Model B005-112, is an in vitro diagnostic device classified as an electrode, ion-specific, for chloride measurement. It is designed for the quantitative determination of immunoreactive trypsin (IRT) in neonatal screening samples, aiding in the early detection of congenital disorders such as cystic fibrosis.
This kit is intended for use in clinical chemistry laboratories and is supplied as a single-use diagnostic reagent. It complies with the In Vitro Diagnostic Device Directive (IVDD) and holds FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent. The kit requires refrigerated storage and is not intended for MRI environments. No additional regulatory authorisations beyond those stated are implied.
Frequently asked questions
What clinical purpose does the Autodelfia Neonatal IRT Kit serve in neonatal screening?
The Autodelfia Neonatal IRT Kit, Model B005-112, is designed for the quantitative determination of immunoreactive trypsin (IRT) in neonatal screening samples. It aids in the early detection of congenital disorders, such as cystic fibrosis, by measuring IRT levels in clinical chemistry laboratories.
Is the Autodelfia Neonatal IRT Kit intended for single-use or repeated use?
The kit is explicitly supplied as a single-use diagnostic reagent, meaning each kit is intended for one-time use only in a clinical setting.
What storage conditions are required for the Autodelfia Neonatal IRT Kit?
The kit requires refrigerated storage, as specified in its handling instructions, to maintain its integrity and performance.
What regulatory pathways does the Autodelfia Neonatal IRT Kit follow, and where was it originally filed?
The kit holds FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent, and complies with the In Vitro Diagnostic Device Directive (IVDD). It was originally filed with the FDA on November 28, 2000, under the Clinical Chemistry advisory committee (CH) and assigned the product code CGZ.
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
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K003668 | Class II | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
Sources (2)
- FDA 510(k) K003668 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026