Autoloader and Nova View (Models ALDR1000, NV2000)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K153150 FDA 510(k)
- FDA Product Code
- PIV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.4750 FDA 510(k)
- Regulation Number
- 866.4750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Autoloader and Nova View (Models ALDR1000, NV2000) is an Automated Indirect Immunofluorescence Microscope and Software-Assisted System for Clinical Use, designed for immunology applications. It automates sample preparation and analysis in indirect immunofluorescence assays, enhancing efficiency and reducing manual handling errors in diagnostic workflows.
This system is supplied as a Class II medical device under FDA 510(k) clearance (K153150) and IVDR compliance, intended for use in clinical immunology laboratories. It operates as a reusable device, with no specific sterility requirements noted, and is regulated under 21 CFR 866.4750. The system integrates with existing workflows to streamline immunofluorescence testing for serological and diagnostic purposes.
Frequently asked questions
What clinical workflows is the AUTOLoader and NOVA view system designed to support, and how does it improve efficiency?
The AUTOLoader (ALDR1000) and NOVA view (NV2000) system automates sample preparation and analysis in indirect immunofluorescence assays, a key technique in clinical immunology. It streamlines workflows by reducing manual handling errors and accelerating diagnostic processes for serological testing, which is critical for conditions like autoimmune diseases, infections, or transplant monitoring. The system integrates seamlessly with existing lab workflows to enhance throughput and reliability.
Is the AUTOLoader reusable, and if so, what maintenance or sterility considerations apply?
Yes, the AUTOLoader and NOVA view system is designed as a reusable device, meaning it is built for repeated use within a clinical immunology lab. Since it is not a single-use instrument, sterility is not a primary concern during operation. However, standard laboratory hygiene practices—such as cleaning and disinfection between uses—should be followed to maintain performance and prevent cross-contamination, as outlined in the manufacturer’s instructions.
What models are available for the AUTOLoader and NOVA view system, and how do they differ?
The system consists of two primary models: the ALDR1000 (AUTOLoader) and the NV2000 (NOVA view). While the data does not specify functional differences between them, the ALDR1000 is likely the automated sample preparation component, and the NV2000 is the software-assisted imaging and analysis module. Together, they form a cohesive system for automated indirect immunofluorescence assays, enhancing both automation and diagnostic accuracy in immunology testing.
How is the regulatory status of this device defined, and which agencies have approved it?
The AUTOLoader and NOVA view system holds FDA 510(k) clearance (K153150) under the Special 510(k) pathway, with a decision of *Substantially Equivalent* to a predicate device, and it complies with the In Vitro Diagnostic Regulation (IVDR) in the EU. The device is classified as a Class II medical device under 21 CFR 866.4750, indicating it has undergone rigorous review by the FDA’s Immunology (IM) Advisory Committee. This regulatory pathway ensures its safety and performance for clinical immunology applications.
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: AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (K153150 ..., AUTOLoader, And NOVA View With Models: ALDR1000, AND NV2000, AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000, PDF K153150 AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000
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 | K153150 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) K153150 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026