510(k) Report

510(k) · Cleared

Cleared

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

K153150510(k) SpecialCleared Nov 24, 201522-day reviewClass II21 CFR 866.4750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inova Diagnostics, Inc. · PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

Cleared on Nov 24, 2015 as substantially equivalent to DEN140039 (Inova Diagnostics, Inc., 2015) after a 22-day review. Its family tree reaches back 1 generation to 2015.

Decided
Nov 24, 2015
Review
22 days
Class
Class II
Product code
PIV
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN140039 (2015). No later device cites it as a predicate yet.

DEN140039 · NOVA View Automated Fluorescense Microscope · Inova Diagnostics, Inc. · 20152016
DEN140039 · NOVA View Automated Fluorescense Microscope · Inova Diagnostics, Inc. · 20150
  1. Root · 1 generation backDEN140039 NOVA View Automated Fluorescense MicroscopeInova Diagnostics, Inc. · 2015
  2. This deviceK153150 AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000Inova Diagnostics, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN140039NOVA View Automated Fluorescense MicroscopeInova Diagnostics, Inc.2015—
0 (this device)K153150AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000Inova Diagnostics, Inc.2015—
FIG. 1 — Lineage of K153150, 2015–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in PIV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN140039NOVA View Automated Fluorescense Microscope
Summary page 7
…munofluorescence Technology microscope and software-assisted system for Same clinical use 11. Regulatory history De novo submission: DEN140039 12. Type of the Product Device technology: indirect immunofluorescence and computer controlled digital imaging and image analys…
Inova Diagnostics, Inc.2015—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All PIV devices

PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · PIV

2in 2015

2015: 2
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PIV

Too few PIV 510(k)s in any year since 2007 to give a median.

Recalls per year · PIV

No recall names PIV since 2007.

Adverse event reports per year · PIV

No MAUDE report names PIV since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20152—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

More from Inova Diagnostics, Inc.

138 FDA decisions under this applicant name. See the company

  • K243979Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026
  • K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
  • K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
  • K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021

Recent decisions in PIV

The PIV category page

  • DEN140039NOVA View Automated Fluorescense MicroscopeInova Diagnostics, Inc. · 2015

https://510kreport.com/device/K153150 · printed Nov 6, 2026

Cite this page

510(k) Report. “K153150: AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153150

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026