FDA product code DOE: Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
DOE is the FDA product code for radioimmunoassay, morphine (125-i), goat antibody ammonium sulfate sep.. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. FDA has cleared 12 510(k) submissions under DOE, from 8 different applicants. The average 510(k) review took 124 days (median 122).
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep. |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| 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 DOE clearance
Top DOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 3 | 1995-06-01 |
| Alfa Scientific Designs, Inc. | 2 | 2001-05-29 |
| Hoffmann-La Roche, Inc. | 2 | 1983-03-24 |
| Pan Probe Biotech, Inc. | 1 | 2001-04-13 |
| Branan Medical Corporation | 1 | 2000-11-22 |
3 more applicants have DOE clearances. See the full list in Caduvo.
Most recent DOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K010080 | Alfa Scientific Designs, Inc. | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | 2001-05-29 | 139 |
| K010079 | Alfa Scientific Designs, Inc. | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | 2001-05-29 | 139 |
| K011011 | Pan Probe Biotech, Inc. | LIVESURE MORPHINE SCREEN TEST | 2001-04-13 | 9 |
| K002418 | Branan Medical Corporation | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | 2000-11-22 | 106 |
| K951319 | Roche Diagnostic Systems, Inc. | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION | 1995-06-01 | 70 |
Recalls for DOE devices
openFDA lists no recalls for product code DOE.
Frequently asked questions
What is FDA product code DOE?
DOE is the FDA product code for radioimmunoassay, morphine (125-i), goat antibody ammonium sulfate sep.. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DOE?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DOE?
Across 12 cleared submissions the average was 124 days from receipt to decision (median 122).
Which companies have the most DOE clearances?
Roche Diagnostic Systems, Inc. (3); Alfa Scientific Designs, Inc. (2); Hoffmann-La Roche, Inc. (2); Pan Probe Biotech, Inc. (1); Branan Medical Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DOE
- Run a recall and safety report across every DOE manufacturer
- Watch product code DOE 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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