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Wallac Neonatal Biotinidase Test Kit, Models NB-1000; NB-4000

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN990008

by Wallac, Inc.

Identifiers

510(k) Number
DEN990008 FDA 510(k)
FDA Product Code
NAK FDA 510(k)
Models / Variants
Wallac Neonatal Biotinidase Test Kit, Models Nb-1000 FDA 510(k)
Nb-4000 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1118 FDA 510(k)
Regulation Number
862.1118 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
DENG FDA 510(k)

The Wallac Neonatal Biotinidase Test Kit is a system, test, biotinidase device designed for the semi-quantitative in vitro measurement of biotinidase enzyme activity in neonatal blood specimens. Biotinidase deficiency, if undetected, can lead to severe metabolic disorders, making early and accurate screening critical for neonatal care. This kit facilitates rapid diagnostic assessment in clinical chemistry laboratories, supporting timely clinical intervention. The device adheres to regulatory standards for Class II medical devices under FDA classification.

The test kit is supplied as a diagnostic reagent system for use in clinical settings, requiring no additional sterilisation as it is intended for single-use per manufacturer specifications. Models NB-1000 and NB-4000 are intended for laboratory use, with performance validated under FDA 510(k) clearance (K-number DEN990008) and classified under regulation 862.1118. Storage conditions and shelf-life are not specified in the regulatory data but must be followed as per accompanying documentation. The device is authorised for use in the United States under the FDA’s 510(k) pathway, with no third-party certification indicated.

Frequently asked questions

What is the Wallac Neonatal Biotinidase Test Kit used for?

The Wallac Neonatal Biotinidase Test Kit (models NB-1000 and NB-4000) is designed for the semi-quantitative in vitro measurement of biotinidase enzyme activity in neonatal blood specimens. Biotinidase deficiency, if left undetected, can lead to severe metabolic disorders, so early and accurate screening is essential for neonatal care. This kit enables clinical chemistry laboratories to perform rapid diagnostic assessments, supporting timely clinical intervention.

How is the Wallac Neonatal Biotinidase Test Kit supplied and intended for use?

The kit is supplied as a diagnostic reagent system for laboratory use. It is intended for single-use per manufacturer specifications, meaning each kit is designed for one test cycle and does not require additional sterilization before use. This ensures consistency and reduces the risk of cross-contamination in clinical settings.

Are the NB-1000 and NB-4000 models interchangeable?

The NB-1000 and NB-4000 models are both intended for laboratory use and share the same primary purpose—measuring biotinidase enzyme activity—but their specific performance characteristics may differ. While they are part of the same product line, their exact specifications (such as test capacity or sensitivity) are not detailed in the provided data. Always refer to the accompanying documentation for model-specific instructions.

What regulatory pathway does the Wallac Neonatal Biotinidase Test Kit follow?

The Wallac Neonatal Biotinidase Test Kit (models NB-1000 and NB-4000) is authorized for use in the United States under the FDA’s 510(k) clearance pathway. It was cleared under the classification for Class II medical devices (regulation 862.1118) and is associated with FDA clearance number DEN990008. This pathway ensures the device meets FDA standards for safety and effectiveness before market authorization.

What storage and shelf-life instructions should be followed for this test kit?

The provided regulatory data does not specify storage conditions or shelf-life details for the Wallac Neonatal Biotinidase Test Kit. However, as with all medical devices, it is critical to follow the storage and handling instructions provided in the accompanying documentation to maintain the kit’s integrity and performance. Improper storage could compromise test accuracy, so adherence to manufacturer guidelines is essential.

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: Wallac Neonatal Biotinidase Test Kit, Models Nb-1000; Nb-4000 ..., fda.innolitics.com, WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS… - FDA.report, Wallac Neonatal Biotinidase Test Kit, Models Nb-1000; Nb-4000

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wallac, Inc.

Sources (1)

  • FDA 510(k) DEN990008 24 fields · synced Oct 1, 2026