FDA product code DBM: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
DBM is the FDA product code for antimitochondrial antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5090 and reviewed by the Immunology panel. FDA has cleared 27 510(k) submissions under DBM, from 24 different applicants. The average 510(k) review took 94 days (median 69). FDA has posted 2 recalls for DBM devices.
Classification
| Field | Value |
|---|---|
| Device name | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5090 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DBM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 268 |
| 2018 | 1 | 30 |
Compare with all 510(k) review times · Search every DBM clearance
Top DBM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Inova Diagnostics, Inc. | 2 | 2017-09-05 |
| Elias U.S.A., Inc. | 2 | 1995-01-24 |
| Zeus Scientific, Inc. | 2 | 1983-06-15 |
| Phadia AB | 1 | 2018-07-13 |
| Immco Diagnostics, Inc. | 1 | 2017-08-08 |
19 more applicants have DBM clearances. See the full list in Caduvo.
Most recent DBM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181556 | Phadia AB | EliA M2 Immunoassay | 2018-07-13 | 30 |
| K163525 | Inova Diagnostics, Inc. | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | 2017-09-05 | 264 |
| K163133 | Immco Diagnostics, Inc. | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA | 2017-08-08 | 273 |
| K141375 | Phadia US, Inc. | ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 | 2015-02-13 | 262 |
| K092736 | Euroimmun Us, Inc. | EUROIMMUN ANTI-M2-3E ELISA (IGG) | 2010-09-02 | 363 |
Recalls for DBM devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2008-07-29.
Frequently asked questions
What is FDA product code DBM?
DBM is the FDA product code for antimitochondrial antibody, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5090 and reviewed by the Immunology panel.
What device class is DBM?
Class II, regulation 21 CFR 866.5090. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBM?
Across 27 cleared submissions the average was 94 days from receipt to decision (median 69).
Which companies have the most DBM clearances?
Inova Diagnostics, Inc. (2); Elias U.S.A., Inc. (2); Zeus Scientific, Inc. (2); Phadia AB (1); Immco Diagnostics, Inc. (1).
Have DBM devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2008-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code DBM
- Run a recall and safety report across every DBM manufacturer
- Watch product code DBM 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