FDA product code DIP: Enzyme Immunoassay, Diphenylhydantoin
DIP is the FDA product code for enzyme immunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel. FDA has cleared 44 510(k) submissions under DIP, from 26 different applicants. The average 510(k) review took 83 days (median 44). FDA has posted 11 recalls for DIP devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Diphenylhydantoin |
| Device class | Class II |
| Regulation | 21 CFR 862.3350 |
| 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 DIP clearance
Top DIP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 10 | 2001-05-17 |
| Abbott Laboratories | 4 | 2008-09-11 |
| E.I. Dupont DE Nemours & Co., Inc. | 3 | 1991-04-03 |
| Em Diagnostic Systems, Inc. | 3 | 1987-01-07 |
| Schiapparelli Biosystems, Inc. | 2 | 1997-11-04 |
21 more applicants have DIP clearances. See the full list in Caduvo.
Most recent DIP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K080696 | Abbott Laboratories | ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 | 2008-09-11 | 183 |
| K063145 | Thermo Electron OY | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS | 2007-10-17 | 366 |
| K030428 | Roche Diagnostics Corp. | ROCHE ONLINE TDM PHENYTOIN | 2003-04-28 | 77 |
| K011393 | Randox Laboratories, Ltd. | RANDOX PHENYTOIN | 2001-12-04 | 211 |
| K011347 | Syva Co. | EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 | 2001-05-17 | 15 |
Recalls for DIP devices
11 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code DIP?
DIP is the FDA product code for enzyme immunoassay, diphenylhydantoin. It is a Class II device, regulated under 21 CFR 862.3350 and reviewed by the Clinical Toxicology panel.
What device class is DIP?
Class II, regulation 21 CFR 862.3350. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIP?
Across 44 cleared submissions the average was 83 days from receipt to decision (median 44).
Which companies have the most DIP clearances?
Syva Co. (10); Abbott Laboratories (4); E.I. Dupont DE Nemours & Co., Inc. (3); Em Diagnostic Systems, Inc. (3); Schiapparelli Biosystems, Inc. (2).
Have DIP devices been recalled?
Yes: 11 product recalls across 9 recall events; the most recent began 2021-01-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DIP
- Run a recall and safety report across every DIP manufacturer
- Watch product code DIP 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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