510(k) · Cleared
ClearedEliA RNA Pol III
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Cleared on Sep 13, 2021 as substantially equivalent to K070066 (Inova Diagnostics, Inc., 2007) after a 376-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- Sep 13, 2021
- Review
- 376 days
- Class
- Class II
- Product code
- NYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070066 (2007). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K253367EliA CTD 13 ScreenPhadia AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070066 | Quanta Lite Rna Pol Iii Elisa | Inova Diagnostics, Inc. | 2007 | — |
| 0 (this device) | K202541 | EliA RNA Pol III | Phadia AB | 2021 | — |
| +1 | K253367 | EliA CTD 13 Screen | Phadia AB | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 NYO? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070066 | Quanta Lite Rna Pol Iii ElisaSummary page 6…for EliA test procedures from sample and reagent handling to the processing of results. Substantial Equivalence QUANTA LITE RNA POL III ELISA, INOVA Diagnostics, Inc. (K070066) Comparison with Predicate Device: Similarities… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253367 | EliA CTD 13 Screen | 2026 | 0 |
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.
- Of its descendants, K253367 (Phadia AB, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NYO devicesNYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NYO
1in 2021
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
MAUDE reports naming product code NYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EliA RNA Pol III is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to RNA
polymerase III (RNA Pol III) in human serum as an aid in the diagnosis of systemic sclerosis (diffuse form) in
conjunction with other laboratory and clinical findings. EliA RNA Pol III uses the EliA IgG method.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202541 · printed Nov 5, 2026
Cite this page
510(k) Report. “K202541: EliA RNA Pol III.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K202541
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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