# DEN140039: NOVA View Automated Fluorescense Microscope

- Pathway: De Novo (Post-NSE)
- Applicant: Inova Diagnostics, Inc.
- Decided: Apr 9, 2015 after 115 days
- Product code: PIV (Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use)
- Device class: 2
- Regulation: 21 CFR 866.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K153150: AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (2015), 0 descendants of its own

## Indications for use
NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.

Source page: https://510kreport.com/device/DEN140039
Methodology: https://510kreport.com/methodology