NOVA Lite DAPI ANA Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150155 FDA 510(k)
- FDA Product Code
- DHN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5100 FDA 510(k)
- Regulation Number
- 866.5100 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The NOVA Lite DAPI ANA Kit is an indirect immunofluorescent assay for the screening and semi-quantitative detection of anti-nuclear IgG antibodies (ANA) in human serum. It is classified as an antigen, control, and indirect immunofluorescence test under regulatory nomenclature (DHN, 866.5100), designed for immunology applications. The assay aids in identifying systemic autoimmune markers, including those associated with systemic lupus erythematosus (SLE) and connective tissue disorders.
This kit is supplied as a reusable diagnostic reagent system for laboratory use, requiring human serum samples for testing. It is not single-use and must be handled in compliance with standard in vitro diagnostic device (IVDD) regulations and FDA 510(k) clearance (K150155). Storage and handling follow manufacturer guidelines to maintain assay integrity, with no specific MRI safety considerations noted. The device is intended for professional medical laboratory settings and adheres to Class II regulatory standards for immunology diagnostics.
Frequently asked questions
What types of samples can the NOVA Lite DAPI ANA Kit analyze, and how is it intended to be used in a clinical setting?
The NOVA Lite DAPI ANA Kit is designed to analyze human serum samples for the indirect immunofluorescent detection of anti-nuclear IgG antibodies (ANA). It is intended for use in professional medical laboratory settings to screen for and semi-quantitatively assess systemic autoimmune markers, such as those linked to conditions like systemic lupus erythematosus (SLE) or connective tissue disorders. The assay helps identify potential autoimmune activity by evaluating antibody presence and patterns.
Is the NOVA Lite DAPI ANA Kit single-use or reusable, and what are the storage requirements to maintain its integrity?
The NOVA Lite DAPI ANA Kit is a reusable diagnostic reagent system, meaning it is not intended for single-use. To maintain assay integrity, it must be stored and handled according to the manufacturer’s guidelines, which likely include proper temperature control and protection from contamination. Since it is classified under IVDD regulations and FDA 510(k) clearance, adherence to these guidelines is critical for reliable performance.
What regulatory pathways does the NOVA Lite DAPI ANA Kit follow, and how does this affect its use in clinical laboratories?
The NOVA Lite DAPI ANA Kit follows both FDA 510(k) clearance (K150155) and IVDD (In Vitro Diagnostic Device Directive) regulatory pathways. This means it has been evaluated for safety and performance under U.S. and European standards, ensuring it meets Class II regulatory requirements for immunology diagnostics. Laboratories must ensure compliance with these regulatory frameworks when integrating the kit into their workflow, particularly regarding validation, quality control, and proper handling procedures.
Are there any special handling considerations for the NOVA Lite DAPI ANA Kit, such as sterility or compatibility with other laboratory equipment?
The NOVA Lite DAPI ANA Kit is a reusable diagnostic reagent system, so sterility is maintained through proper cleaning and disinfection protocols as outlined by the manufacturer. While it is not explicitly described as requiring MRI safety considerations, it is designed for laboratory use only and must be handled in compliance with standard IVDD and FDA guidelines. There are no indications of compatibility issues with specific laboratory equipment, but users should follow the manufacturer’s instructions to ensure optimal performance and safety.
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: NOVA Lite (R) DAPI ANA Kit | Werfen North America, NOVA Lite DAPI ANA Kit (K150155) — FDA 510 (k) | Innolitics, PDF Department of Health & Human Services, NOVA Lite | Werfen North America
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 | K150155 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) K150155 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 29, 2026