FDA product code DBL: Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
DBL is the FDA product code for multiple autoantibodies, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 24 510(k) submissions under DBL, from 19 different applicants. The average 510(k) review took 178 days (median 82). FDA has posted 1 recall for DBL devices.
Classification
| Field | Value |
|---|---|
| Device name | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| 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 DBL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 268 |
Compare with all 510(k) review times · Search every DBL clearance
Top DBL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Immco Diagnostics, Inc. | 5 | 1994-09-26 |
| Light Diagnostics | 2 | 1995-03-06 |
| Immuno Concepts, N.A. , Ltd. | 1 | 2018-10-19 |
| Inova Diagnostics, Inc. | 1 | 1998-04-02 |
| Wieslab AB | 1 | 1998-02-17 |
14 more applicants have DBL clearances. See the full list in Caduvo.
Most recent DBL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K180202 | Immuno Concepts, N.A. , Ltd. | Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts | 2018-10-19 | 268 |
| K980312 | Inova Diagnostics, Inc. | NOVA LITE ENDOMYSIAL | 1998-04-02 | 65 |
| K974169 | Wieslab AB | WIELISA ANTI-GBM TEST SYSTEM | 1998-02-17 | 104 |
| K971464 | Euro-Diagnostica AB | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | 1997-10-29 | 190 |
| K971658 | Jay H. Geller | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | 1997-05-23 | 39 |
Recalls for DBL devices
1 product recalls in 1 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 DBL?
DBL is the FDA product code for multiple autoantibodies, indirect immunofluorescent, antigen, control. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is DBL?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBL?
Across 24 cleared submissions the average was 178 days from receipt to decision (median 82).
Which companies have the most DBL clearances?
Immco Diagnostics, Inc. (5); Light Diagnostics (2); Immuno Concepts, N.A. , Ltd. (1); Inova Diagnostics, Inc. (1); Wieslab AB (1).
Have DBL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2008-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code DBL
- Run a recall and safety report across every DBL manufacturer
- Watch product code DBL 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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