510(k) · Cleared
ClearedImmuLisa Enhanced RNA POL III Antibody ELISA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
Cleared on Mar 30, 2018 after a 263-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 30, 2018
- Review
- 263 days
- Class
- Class II
- Product code
- NYO
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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.
Top candidate predicates for a new NYO device
- #1 K202541 EliA RNA Pol IIIscore 5.0 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | — | INOVA QUANTA Lite™ RNA POL III ELISA Named without a submission number |
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.
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. 2018, 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?
An enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of anti-RNA POL III IgG antibodies in human serum as an aid in diagnosis of systemic sclerosis (scleroderma) in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172078: ImmuLisa Enhanced RNA POL III Antibody ELISA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172078
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026