Cleared Special

K153150 - AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 (FDA 510(k) Clearance)

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

K153150 is an FDA 510(k) clearance for the AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000. Classified as Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use (product code PIV), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on November 24, 2015 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4750 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K153150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 104d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PIV Automated Indirect Immunofluorescence Microscope And Software-assisted System For Clinical Use
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.