Cleared Special

AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000

K153150 · Inova Diagnostics, Inc. · Immunology
Nov 2015
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K153150 is an FDA 510(k) clearance for the AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000, a Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use (Class II — Special Controls, product code PIV), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 24, 2015, 22 days after receiving the submission on November 2, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.4750.

Submission Details

510(k) Number K153150 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2015
Decision Date November 24, 2015
Days to Decision 22 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code PIV — Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.4750
Definition 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 Immunofluorescent Technology. A Trained Operator Must Confirm All Device Generated Results.