FDA product code DAD: Haptoglobin, Antigen, Antiserum, Control
DAD is the FDA product code for haptoglobin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5460 and reviewed by the Immunology panel. FDA has cleared 18 510(k) submissions under DAD, from 18 different applicants. The average 510(k) review took 64 days (median 34). FDA has posted 1 recall for DAD devices.
Classification
| Field | Value |
|---|---|
| Device name | Haptoglobin, Antigen, Antiserum, Control |
| Device class | Class II |
| Regulation | 21 CFR 866.5460 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Top DAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kamiya Biomedical Co. | 1 | 1999-11-24 |
| Boehringer Mannheim Corp. | 1 | 1998-01-09 |
| Crestat Diagnostics, Inc. | 1 | 1997-07-14 |
| Beckman Instruments, Inc. | 1 | 1996-10-07 |
| Behring Diagnostics, Inc. | 1 | 1995-07-17 |
13 more applicants have DAD clearances. See the full list in Caduvo.
Most recent DAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K993480 | Kamiya Biomedical Co. | K-ASSAY HAPTOGLOBIN | 1999-11-24 | 41 |
| K972639 | Boehringer Mannheim Corp. | TINA-QUANT HAPTOGLOBIN | 1998-01-09 | 178 |
| K964301 | Crestat Diagnostics, Inc. | N-ASSAY TIA MULTI V-NL | 1997-07-14 | 258 |
| K963286 | Beckman Instruments, Inc. | IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT | 1996-10-07 | 47 |
| K952593 | Behring Diagnostics, Inc. | N/T PROTEIN CONTROL SY/L, M AND H | 1995-07-17 | 41 |
Recalls for DAD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-05-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code DAD?
DAD is the FDA product code for haptoglobin, antigen, antiserum, control. It is a Class II device, regulated under 21 CFR 866.5460 and reviewed by the Immunology panel.
What device class is DAD?
Class II, regulation 21 CFR 866.5460. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DAD?
Across 18 cleared submissions the average was 64 days from receipt to decision (median 34).
Which companies have the most DAD clearances?
Kamiya Biomedical Co. (1); Boehringer Mannheim Corp. (1); Crestat Diagnostics, Inc. (1); Beckman Instruments, Inc. (1); Behring Diagnostics, Inc. (1).
Have DAD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2018-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code DAD
- Run a recall and safety report across every DAD manufacturer
- Watch product code DAD 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.