FDA product code DON: Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.
DON is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, solid phase sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 17 510(k) submissions under DON, from 15 different applicants. The average 510(k) review took 37 days (median 33).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DON clearance
Top DON applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ciba Corning Diagnostics Corp. | 2 | 1990-09-10 |
| Burroughs Wellcome Co. | 2 | 1978-04-24 |
| Corning Medical & Scientific | 1 | 1984-03-23 |
| Medical & Scientific Designs, Inc. | 1 | 1983-04-05 |
| Biological & Diagnostic Products | 1 | 1982-07-27 |
10 more applicants have DON clearances. See the full list in Caduvo.
Most recent DON clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K902861 | Ciba Corning Diagnostics Corp. | CIBA CORNING ACS DIGOXIN IMMUNOASSAY | 1990-09-10 | 74 |
| K881679 | Ciba Corning Diagnostics Corp. | CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY | 1988-07-08 | 80 |
| K840461 | Corning Medical & Scientific | MAGIC 125I DIGOXIN RADIOIMMUNOASSAY | 1984-03-23 | 50 |
| K830533 | Medical & Scientific Designs, Inc. | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | 1983-04-05 | 46 |
| K822053 | Biological & Diagnostic Products | ZETAPHASE-DIG | 1982-07-27 | 14 |
Recalls for DON devices
openFDA lists no recalls for product code DON.
Frequently asked questions
What is FDA product code DON?
DON is the FDA product code for radioimmunoassay, digoxin (125-i), rabbit antibody, solid phase sep.. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is DON?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code DON?
Across 17 cleared submissions the average was 37 days from receipt to decision (median 33).
Which companies have the most DON clearances?
Ciba Corning Diagnostics Corp. (2); Burroughs Wellcome Co. (2); Corning Medical & Scientific (1); Medical & Scientific Designs, Inc. (1); Biological & Diagnostic Products (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DON
- Run a recall and safety report across every DON manufacturer
- Watch product code DON 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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