FDA product code MID: System, Test, Anticardiolipin Immunological
MID is the FDA product code for system, test, anticardiolipin immunological. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 94 510(k) submissions under MID, 1 in the last five years, from 32 different applicants. The average 510(k) review took 155 days (median 88); 809 days on average over the last three years. FDA has posted 17 recalls for MID devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Anticardiolipin Immunological |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MID
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 809 |
Compare with all 510(k) review times · Search every MID clearance
Top MID applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 9 | 2024-12-17 |
| Zeus Scientific, Inc. | 9 | 2011-12-12 |
| Corgenix, Inc. | 8 | 2003-10-14 |
| Elias U.S.A., Inc. | 7 | 1995-10-02 |
| Immco Diagnostics, Inc. | 5 | 2012-10-25 |
27 more applicants have MID clearances. See the full list in Caduvo.
Most recent MID clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223093 | Inova Diagnostics, Inc. | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | 2024-12-17 | 809 |
| K131821 | Phadia US, Inc. | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | 2013-12-23 | 186 |
| K130528 | Bio-Rad Laboratories | BIOPLEX 2200 APLS IGM | 2013-10-21 | 234 |
| K120817 | Inova Diagnostics, Inc. | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | 2013-02-26 | 344 |
| K113020 | Immco Diagnostics, Inc. | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | 2012-10-25 | 380 |
Recalls for MID devices
17 product recalls in 13 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-02-28.
| Year | Recalls |
|---|---|
| 2023 | 1 |
Frequently asked questions
What is FDA product code MID?
MID is the FDA product code for system, test, anticardiolipin immunological. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is MID?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code MID?
Across 94 cleared submissions the average was 155 days from receipt to decision (median 88).
Which companies have the most MID clearances?
Inova Diagnostics, Inc. (9); Zeus Scientific, Inc. (9); Corgenix, Inc. (8); Elias U.S.A., Inc. (7); Immco Diagnostics, Inc. (5).
Have MID devices been recalled?
Yes: 17 product recalls across 13 recall events; the most recent began 2023-02-28.
Next steps
- Run an FDA pathway report with predicate devices for product code MID
- Run a recall and safety report across every MID manufacturer
- Watch product code MID 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.
All Immunology product codes · FDA product code lookup · 510(k) database search · 510(k) review times