510(k) Report

510(k) · Cleared

Cleared

Quanta Lite Rna Pol Iii Elisa

K070066510(k) TraditionalCleared Apr 11, 200793-day reviewClass II21 CFR 866.5100

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

Inova Diagnostics, Inc. · NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

Cleared on Apr 11, 2007 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided
Apr 11, 2007
Review
93 days
Class
Class II
Product code
NYO
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2021: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK070066 Quanta Lite Rna Pol Iii ElisaInova Diagnostics, Inc. · 2007
  2. Descendant · cites it directly · 1 of its ownK202541 EliA RNA Pol IIIPhadia AB · 2021
  3. Descendant · 2 generations on · 0 of its ownK253367 EliA CTD 13 ScreenPhadia AB · 2026

Most influential descendants

Showing 2 of 2 · See all
  • K202541EliA RNA Pol IIIPhadia AB · 2021 · cites it directly1descendant
  • K253367EliA CTD 13 ScreenPhadia AB · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070066Quanta Lite Rna Pol Iii ElisaInova Diagnostics, Inc.2007—
+1K202541EliA RNA Pol IIIPhadia AB2021—
+2K253367EliA CTD 13 ScreenPhadia AB2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202610
FIG. 1 — Lineage of K070066, 2007–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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

Top candidate predicates for a new NYO device

  1. #1 K202541 EliA RNA Pol IIIscore 5.0 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202541EliA RNA Pol IIIPhadia AB20211

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?

  • Of its descendants, K202541 (Phadia AB, 2021) has gone furthest, with 1 descendant of its own.

How does its category compare?

All NYO devices

NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NYO

1in 2021

2007: 12018: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NYO

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

Recalls per year · NYO

No recall names NYO since 2007.

Adverse event reports per year · NYO

2in 2014

2012: 32014: 2
2007high 3 (2012) · low 0 (2007)2025

MAUDE reports naming product code NYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—03
20130—00
20140—02
20150—00
20160—00
20170—00
20181—00
20190—00
20200—00
20211—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The QUANTA LiteTM RNA Pol III ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-RNA Polymerase III antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic sclerosis (scleroderma) with increased incidence of skin involvement and renal crisis.

Indications for use as stated in the FDA 510(k) statement.

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 NYO

The NYO category page

  • K202541EliA RNA Pol IIIPhadia AB · 2021
  • K172078ImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc. · 2018
  • K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006

https://510kreport.com/device/K070066 · printed Nov 5, 2026

Cite this page

510(k) Report. “K070066: Quanta Lite Rna Pol Iii Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070066

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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