FDA product code MOI: System, Test, Immunological, Antigen, Tumor
MOI is the FDA product code for system, test, immunological, antigen, tumor. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel. FDA has cleared 28 510(k) submissions under MOI, 2 in the last five years, from 17 different applicants. The average 510(k) review took 165 days (median 121); 90 days on average over the last three years. FDA has posted 18 recalls for MOI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Immunological, Antigen, Tumor |
| Device class | Class II |
| Regulation | 21 CFR 866.6010 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 140 |
| 2019 | 1 | 53 |
| 2020 | 2 | 208 |
| 2024 | 2 | 90 |
Compare with all 510(k) review times · Search every MOI clearance
Top MOI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 3 | 2024-05-09 |
| Chiron Diagnostics Corp. | 3 | 1998-10-15 |
| Fujirebio Diagnostics,Inc. | 2 | 2020-09-04 |
| Siemens Healthcare Diagnostics, Inc. | 2 | 2020-02-13 |
| Roche Diagnostics | 2 | 2018-06-22 |
12 more applicants have MOI clearances. See the full list in Caduvo.
Most recent MOI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240403 | Beckman Coulter, Inc. | Access BR Monitor | 2024-05-09 | 90 |
| K233946 | Siemens Healthcare Diagnostics Products, Ltd. | IMMULITE® 2000 BR-MA | 2024-03-13 | 90 |
| K192524 | Fujirebio Diagnostics,Inc. | Lumipulse G CA15-3 | 2020-09-04 | 357 |
| K193489 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur BR | 2020-02-13 | 58 |
| K192777 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur CA 15-3 assay | 2019-11-22 | 53 |
Recalls for MOI devices
18 product recalls in 11 recall events; 1 initiated in the last five years and 4 still open. Most recent: 2022-07-18.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 3 |
| 2021 | 3 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code MOI?
MOI is the FDA product code for system, test, immunological, antigen, tumor. It is a Class II device, regulated under 21 CFR 866.6010 and reviewed by the Immunology panel.
What device class is MOI?
Class II, regulation 21 CFR 866.6010. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOI?
Across 28 cleared submissions the average was 165 days from receipt to decision (median 121).
Which companies have the most MOI clearances?
Beckman Coulter, Inc. (3); Chiron Diagnostics Corp. (3); Fujirebio Diagnostics,Inc. (2); Siemens Healthcare Diagnostics, Inc. (2); Roche Diagnostics (2).
Have MOI devices been recalled?
Yes: 18 product recalls across 11 recall events; the most recent began 2022-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code MOI
- Run a recall and safety report across every MOI manufacturer
- Watch product code MOI 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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