FDA product code MYA: Immunohistochemistry Antibody Assay, Estrogen Receptor
MYA is the FDA product code for immunohistochemistry antibody assay, estrogen receptor. 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 MYA, from 11 different applicants. The average 510(k) review took 295 days (median 288). FDA has posted 3 recalls for MYA devices.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Antibody Assay, Estrogen Receptor |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MYA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 352 |
| 2018 | 1 | 30 |
Compare with all 510(k) review times · Search every MYA clearance
Top MYA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dako North America, Inc. | 2 | 2013-02-12 |
| Leica Biosystems Newcastle, Limited | 1 | 2018-12-07 |
| Dako Denmark A/S | 1 | 2017-12-21 |
| Leica Biosystems Newcastle, Ltd. | 1 | 2014-05-19 |
| Ventana Medical Systems, Inc. | 1 | 2012-12-17 |
6 more applicants have MYA clearances. See the full list in Caduvo.
Most recent MYA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183100 | Leica Biosystems Newcastle, Limited | Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra | 2018-12-07 | 30 |
| K170028 | Dako Denmark A/S | FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis) | 2017-12-21 | 352 |
| K122556 | Leica Biosystems Newcastle, Ltd. | VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11) | 2014-05-19 | 635 |
| K120663 | Dako North America, Inc. | MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI | 2013-02-12 | 344 |
| K110215 | Ventana Medical Systems, Inc. | CONFIRM ANTI-ESTROGEN RECEPTOR (SP1) RABBIT MONOCLONAL PRIMARY ANTIBODY | 2012-12-17 | 719 |
Recalls for MYA devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MYA?
MYA is the FDA product code for immunohistochemistry antibody assay, estrogen receptor. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is MYA?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code MYA?
Across 12 cleared submissions the average was 295 days from receipt to decision (median 288).
Which companies have the most MYA clearances?
Dako North America, Inc. (2); Leica Biosystems Newcastle, Limited (1); Dako Denmark A/S (1); Leica Biosystems Newcastle, Ltd. (1); Ventana Medical Systems, Inc. (1).
Have MYA devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2018-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MYA
- Run a recall and safety report across every MYA manufacturer
- Watch product code MYA 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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