FDA product code DEH: Lambda, Antigen, Antiserum, Control
DEH is the FDA product code for lambda, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel. FDA has cleared 53 510(k) submissions under DEH, from 15 different applicants. The average 510(k) review took 406 days (median 203). FDA has posted 4 recalls for DEH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lambda, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5550 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DEH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 266 |
Compare with all 510(k) review times · Search every DEH clearance
Top DEH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ventana Medical Systems, Inc. | 17 | 2018-05-08 |
| Dako Corp. | 9 | 1997-12-12 |
| The Binding Site, Ltd. | 7 | 2004-01-30 |
| Biotek Solutions, Inc. | 4 | 1996-07-02 |
| Kallestad Laboratories, Inc. | 4 | 1986-02-26 |
10 more applicants have DEH clearances. See the full list in Caduvo.
Most recent DEH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K172471 | Ventana Medical Systems, Inc. | VENTANA CD30 (Ber-H2) RxDx Assay | 2018-05-08 | 266 |
| K140396 | The Binding Site Group , Ltd. | FREELITE HUMAN LAMBDA FREE KIT | 2014-04-16 | 57 |
| K083601 | SENTINEL CH. SpA | LAMBDA LIGHT CHAINS | 2009-06-22 | 199 |
| K033811 | The Binding Site, Ltd. | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER | 2004-01-30 | 52 |
| K031016 | The Binding Site, Ltd. | FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II | 2003-07-15 | 106 |
Recalls for DEH devices
4 product recalls in 4 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-10-15.
| Year | Recalls |
|---|---|
| 2021 | 1 |
Frequently asked questions
What is FDA product code DEH?
DEH is the FDA product code for lambda, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5550 and reviewed by the Immunology panel.
What device class is DEH?
Class II, regulation 21 CFR 866.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DEH?
Across 53 cleared submissions the average was 406 days from receipt to decision (median 203).
Which companies have the most DEH clearances?
Ventana Medical Systems, Inc. (17); Dako Corp. (9); The Binding Site, Ltd. (7); Biotek Solutions, Inc. (4); Kallestad Laboratories, Inc. (4).
Have DEH devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2021-10-15.
Next steps
- Run an FDA pathway report with predicate devices for product code DEH
- Run a recall and safety report across every DEH manufacturer
- Watch product code DEH 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