FDA product code NYO: Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
NYO is the FDA product code for autoantibodies, anti-ribonucleic acid polymerase (rnap) iii antibody. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under NYO, from 4 different applicants. The average 510(k) review took 212 days (median 190).
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody |
| Device class | Class II |
| Regulation | 21 CFR 866.5100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NYO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 263 |
| 2021 | 1 | 376 |
Compare with all 510(k) review times · Search every NYO clearance
Top NYO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Phadia AB | 1 | 2021-09-13 |
| Immco Diagnostics, Inc. | 1 | 2018-03-30 |
| Inova Diagnostics, Inc. | 1 | 2007-04-11 |
| Mbl International Corporation | 1 | 2006-06-19 |
Most recent NYO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202541 | Phadia AB | EliA RNA Pol III | 2021-09-13 | 376 |
| K172078 | Immco Diagnostics, Inc. | ImmuLisa Enhanced RNA POL III Antibody ELISA | 2018-03-30 | 263 |
| K070066 | Inova Diagnostics, Inc. | QUANTA LITE RNA POL III ELISA | 2007-04-11 | 93 |
| K060431 | Mbl International Corporation | ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 | 2006-06-19 | 118 |
Recalls for NYO devices
openFDA lists no recalls for product code NYO.
Frequently asked questions
What is FDA product code NYO?
NYO is the FDA product code for autoantibodies, anti-ribonucleic acid polymerase (rnap) iii antibody. It is a Class II device, regulated under 21 CFR 866.5100 and reviewed by the Immunology panel.
What device class is NYO?
Class II, regulation 21 CFR 866.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYO?
Across 4 cleared submissions the average was 212 days from receipt to decision (median 190).
Which companies have the most NYO clearances?
Phadia AB (1); Immco Diagnostics, Inc. (1); Inova Diagnostics, Inc. (1); Mbl International Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYO
- Run a recall and safety report across every NYO manufacturer
- Watch product code NYO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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