510(k) Report

FDA product code · Immunology

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

NYOClass II21 CFR 866.5100510(k) required4 decisions since 20060 recalls

4 FDA decisions since 2006. 510(k) reviews decided 2021–2025 took a median of 376 days (half between 376 and 376). No recall names this code. The most-cited predicate is K202541, named by 1 later device.

The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.

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

FIG. A — Illustration, immunology panel

Twenty years of NYO at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — NYO by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NYO? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NYO devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K202541EliA RNA Pol IIIPhadia AB · 20211cites it
  • K070066Quanta Lite Rna Pol Iii ElisaInova Diagnostics, Inc. · 20071cites it

Which NYO devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 20063generations
  • K202541EliA RNA Pol IIIPhadia AB · 20211generation

What has FDA decided in NYO lately?

  • K202541EliA RNA Pol IIIPhadia AB · 2021
  • K172078ImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc. · 2018
  • K070066Quanta Lite Rna Pol Iii ElisaInova Diagnostics, Inc. · 2007
  • K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation · 2006

All 4 NYO decisions →

Related product codes

Other codes under 21 CFR 866.5100.

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