FDA product code DBI: Complement C4, Antigen, Antiserum, Control
DBI is the FDA product code for complement c4, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel. FDA has cleared 34 510(k) submissions under DBI, from 27 different applicants. The average 510(k) review took 82 days (median 44). FDA has posted 2 recalls for DBI devices.
Classification
| Field | Value |
|---|---|
| Device name | Complement C4, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5240 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DBI clearance
Top DBI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crestat Diagnostics, Inc. | 2 | 1997-07-14 |
| Instrumentation Laboratory CO | 2 | 1996-09-26 |
| Technicon Instruments Corp. | 2 | 1988-07-08 |
| Boehringer Mannheim Corp. | 2 | 1987-05-14 |
| Kallestad Laboratories, Inc. | 2 | 1986-02-26 |
22 more applicants have DBI clearances. See the full list in Caduvo.
Most recent DBI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K100455 | The Binding Site | SPAPLUS ANALYZER | 2010-09-03 | 198 |
| K012359 | Roche Diagnostics Corp. | TINA-QUANT COMPLEMENT C4 TEST SYSTEM | 2001-11-29 | 127 |
| K010325 | Wako Chemicals USA, Inc. | WAKO AUTOKIT C4 | 2001-06-25 | 143 |
| K000468 | Randox Laboratories, Ltd. | RANDOX COMPLEMENT C4 | 2000-03-27 | 45 |
| K994293 | Dade Behring, Inc. | DIMENSION C4 FLEX REAGENT CARTRIDGE | 2000-03-01 | 71 |
Recalls for DBI devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-27.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code DBI?
DBI is the FDA product code for complement c4, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5240 and reviewed by the Immunology panel.
What device class is DBI?
Class II, regulation 21 CFR 866.5240. Typical premarket route: 510(k).
How long does a 510(k) take for product code DBI?
Across 34 cleared submissions the average was 82 days from receipt to decision (median 44).
Which companies have the most DBI clearances?
Crestat Diagnostics, Inc. (2); Instrumentation Laboratory CO (2); Technicon Instruments Corp. (2); Boehringer Mannheim Corp. (2); Kallestad Laboratories, Inc. (2).
Have DBI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2020-08-27.
Next steps
- Run an FDA pathway report with predicate devices for product code DBI
- Run a recall and safety report across every DBI manufacturer
- Watch product code DBI 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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