FDA product code NQN: Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
NQN is the FDA product code for microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 15 510(k) submissions under NQN, from 8 different applicants. The average 510(k) review took 242 days (median 248). FDA has posted 4 recalls for NQN devices.
Definition
Automated microscopic immunohistochemistry image- analysis system to measure nuclear intensity and percent positivity with operator intervention.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NQN clearance
Top NQN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 6 | 2014-03-20 |
| Tripath Imaging, Inc. | 3 | 2006-09-29 |
| Applied Spectral Imaging , Ltd. | 1 | 2015-01-15 |
| Bioimagene, Inc. | 1 | 2010-10-27 |
| Aperio Technologies | 1 | 2008-08-01 |
3 more applicants have NQN clearances. See the full list in Caduvo.
Most recent NQN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140957 | Applied Spectral Imaging , Ltd. | GENASIS HIPATH IHC FAMILY | 2015-01-15 | 276 |
| K140465 | Ventana Medical Systems, Inc. | VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER | 2014-03-20 | 24 |
| K130515 | Ventana Medical Systems, Inc. | VIRTUOSO SYSTEM FOR IHC ER (SPI) | 2013-11-22 | 268 |
| K121516 | Ventana Medical Systems, Inc. | VIRTUOSO SYSTEM FOR IHC HER2 (4B5) | 2013-09-26 | 492 |
| K122143 | Ventana Medical Systems, Inc. | VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINER | 2013-09-19 | 427 |
Recalls for NQN devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-11-23.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code NQN?
NQN is the FDA product code for microscope, automated, image analysis, immunohistochemistry,operator intervention,nuclear intensity & percent positivity. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NQN?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQN?
Across 15 cleared submissions the average was 242 days from receipt to decision (median 248).
Which companies have the most NQN clearances?
Ventana Medical Systems, Inc. (6); Tripath Imaging, Inc. (3); Applied Spectral Imaging , Ltd. (1); Bioimagene, Inc. (1); Aperio Technologies (1).
Have NQN devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2020-11-23.
Next steps
- Run an FDA pathway report with predicate devices for product code NQN
- Run a recall and safety report across every NQN manufacturer
- Watch product code NQN 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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