FDA product code DIW: Hemagglutination Inhibition, Methadone
DIW is the FDA product code for hemagglutination inhibition, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DIW, from 4 different applicants. The average 510(k) review took 42 days (median 46).
Classification
| Field | Value |
|---|---|
| Device name | Hemagglutination Inhibition, Methadone |
| Device class | Class II |
| Regulation | 21 CFR 862.3620 |
| 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 DIW clearance
Top DIW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E.I. Dupont DE Nemours & Co., Inc. | 1 | 1995-03-21 |
| Roche Diagnostic Systems, Inc. | 1 | 1993-04-20 |
| Technam, Inc. | 1 | 1980-07-14 |
| J.T. Baker Chemical Co. | 1 | 1976-07-20 |
Most recent DIW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K950182 | E.I. Dupont DE Nemours & Co., Inc. | URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE | 1995-03-21 | 63 |
| K930845 | Roche Diagnostic Systems, Inc. | ROCHE ABUSCREEN ONTRAK FOR METHADONE | 1993-04-20 | 61 |
| K801509 | Technam, Inc. | HI-M-TEST FOR METHADONE TEST #2 | 1980-07-14 | 14 |
| K760075 | J.T. Baker Chemical Co. | KIT, METHADONE (TOXI-PAK IMMUNO HI) | 1976-07-20 | 32 |
Recalls for DIW devices
openFDA lists no recalls for product code DIW.
Frequently asked questions
What is FDA product code DIW?
DIW is the FDA product code for hemagglutination inhibition, methadone. It is a Class II device, regulated under 21 CFR 862.3620 and reviewed by the Clinical Toxicology panel.
What device class is DIW?
Class II, regulation 21 CFR 862.3620. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIW?
Across 4 cleared submissions the average was 42 days from receipt to decision (median 46).
Which companies have the most DIW clearances?
E.I. Dupont DE Nemours & Co., Inc. (1); Roche Diagnostic Systems, Inc. (1); Technam, Inc. (1); J.T. Baker Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DIW
- Run a recall and safety report across every DIW manufacturer
- Watch product code DIW 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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