FDA product code NOT: Microscope, Automated, Image Analysis, Operator Intervention
NOT is the FDA product code for microscope, automated, image analysis, operator intervention. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 12 510(k) submissions under NOT, from 7 different applicants. The average 510(k) review took 222 days (median 168). FDA has posted 2 recalls for NOT devices.
Definition
Automated microscopic immunohistochemistry image-analysis system to measure cell membrane intensity and pattern with operator intervention.
Classification
| Field | Value |
|---|---|
| Device name | Microscope, Automated, Image Analysis, Operator Intervention |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
Top NOT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 4 | 2013-09-06 |
| Aperio Technologies | 2 | 2009-08-14 |
| Bioimagene, Inc. | 2 | 2009-02-04 |
| Leica Biosystems Imaging, Inc. | 1 | 2014-07-29 |
| Tripath Imaging, Inc. | 1 | 2005-08-16 |
2 more applicants have NOT clearances. See the full list in Caduvo.
Most recent NOT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141109 | Leica Biosystems Imaging, Inc. | APERIO EPATHOLOGY EIHC IVD SYSTEM | 2014-07-29 | 91 |
| K121033 | Ventana Medical Systems, Inc. | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | 2013-09-06 | 519 |
| K121350 | Ventana Medical Systems, Inc. | VIRTUSO SYSTEM FOR IHC (DO-7) | 2012-06-01 | 28 |
| K111755 | Ventana Medical Systems, Inc. | VIRTUOSO SYSTEM FOR IHC KI-67 (30-9) | 2012-02-22 | 245 |
| K111543 | Ventana Medical Systems, Inc. | VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5) | 2011-10-12 | 132 |
Recalls for NOT devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NOT?
NOT is the FDA product code for microscope, automated, image analysis, operator intervention. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is NOT?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOT?
Across 12 cleared submissions the average was 222 days from receipt to decision (median 168).
Which companies have the most NOT clearances?
Ventana Medical Systems, Inc. (4); Aperio Technologies (2); Bioimagene, Inc. (2); Leica Biosystems Imaging, Inc. (1); Tripath Imaging, Inc. (1).
Have NOT devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2018-12-10.
Next steps
- Run an FDA pathway report with predicate devices for product code NOT
- Run a recall and safety report across every NOT manufacturer
- Watch product code NOT 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.