Delfia Neonatal IRT Kit, Model A005-110
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Wallac Oy
Identifiers
- 510(k) Number
- K003664 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 Delfia Neonatal IRT Kit, Model A005-110, is a time-resolved fluoroimmunoassay system designed for the quantitative measurement of immunoreactive trypsin (IRT) in neonatal dried blood spot samples. It is classified as an electrode, ion-specific, chloride device under the FDA’s nomenclature and is intended for use in clinical chemistry laboratories to aid in the screening for cystic fibrosis.
The kit is supplied as a single-use diagnostic reagent system and requires no special storage conditions beyond refrigeration. It is authorized under the FDA’s 510(k) clearance (K003664) and the In Vitro Diagnostic Device Directive (IVDD). The kit is intended for use in laboratory settings and is not MRI-compatible. Each kit includes plates for testing, and the model number A005-110 ensures traceability for regulatory and quality control purposes.
Frequently asked questions
What is the primary clinical use of the Delfia Neonatal IRT Kit, Model A005-110, and how does it function in a lab setting?
The Delfia Neonatal IRT Kit, Model A005-110, is designed for the quantitative measurement of immunoreactive trypsin (IRT) in neonatal dried blood spot samples. It uses a time-resolved fluoroimmunoassay system to aid in screening for cystic fibrosis by detecting elevated IRT levels in newborns. The kit is intended for use exclusively in clinical chemistry laboratories, where trained personnel can process samples and interpret results.
Is the Delfia Neonatal IRT Kit single-use, and if so, what does this mean for workflow efficiency in a lab?
Yes, the Delfia Neonatal IRT Kit is a single-use diagnostic reagent system, meaning each kit is intended for one testing session only. This design eliminates the need for cleaning or reprocessing between uses, reducing contamination risks and simplifying workflow by ensuring consistent performance without cross-sample carryover. However, labs must account for kit consumption when scaling up testing volume.
What storage requirements apply to the Delfia Neonatal IRT Kit, and can it be stored at room temperature?
The kit does not require special storage conditions beyond refrigeration. While it can be stored in a standard refrigerator (typically 2–8°C), it should not be exposed to room temperature or freezing temperatures, as this could compromise its stability or accuracy. Always check the packaging for expiration dates and storage instructions before use.
How does the regulatory approval process for this kit impact its use in clinical settings?
The Delfia Neonatal IRT Kit holds FDA 510(k) clearance (K003664) and IVDD authorization, confirming it meets U.S. and European regulatory standards for safety and performance. This approval ensures the kit can be legally used in FDA-regulated labs (e.g., CLIA-certified facilities) and aligns with In Vitro Diagnostic Device Directive (IVDD) compliance in the EU. Clinicians should verify their local regulatory requirements to confirm compatibility with their testing protocols.
What does the model number A005-110 indicate about traceability and quality control for this kit?
The model number A005-110 serves as a traceability identifier, allowing labs to track the kit’s batch, expiration, and regulatory compliance history. This is critical for quality control audits, inventory management, and ensuring consistency in cystic fibrosis screening programs. The model number also helps distinguish this specific version from other iterations, which may have undergone updates or modifications.
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: DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664) — FDA 510 (k ..., DELFIA NEONATAL IRT KIT, MODEL A005-110 510(k) K003664 - fda.report, DELFIA NEONATAL IRT KIT, MODEL A005-110 (K003664) — FDA 510 (k ..., DELFIA Neonatal IRT kit (4 plate) - Revvity, 510(k) K003664 — DELFIA NEONATAL IRT KIT, MODEL A005-110
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 | K003664 | Class II | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
Sources (2)
- FDA 510(k) K003664 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026