FDA product code DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites
DIO is the FDA product code for enzyme immunoassay, cocaine and cocaine metabolites. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel. FDA has cleared 145 510(k) submissions under DIO, 1 in the last five years, from 71 different applicants. The average 510(k) review took 117 days (median 80). FDA has posted 23 recalls for DIO devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Device class | Class II |
| Regulation | 21 CFR 862.3250 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DIO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 262 |
| 2018 | 1 | 29 |
| 2020 | 1 | 267 |
| 2021 | 1 | 91 |
| 2022 | 1 | 120 |
Compare with all 510(k) review times · Search every DIO clearance
Top DIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 9 | 2000-01-27 |
| Roche Diagnostic Systems, Inc. | 9 | 1998-12-11 |
| Princeton BioMeditech Corp. | 7 | 2002-06-10 |
| Abbott Laboratories | 6 | 2002-03-13 |
| Guangzhou Wondfo Biotech Co., Ltd. | 4 | 2016-06-27 |
66 more applicants have DIO clearances. See the full list in Caduvo.
Most recent DIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Corp. | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System | 2022-01-27 | 120 |
| K211973 | Microgenics Corporation | DRI Cocaine Metabolite Assay | 2021-09-24 | 91 |
| K191638 | Medtest DX | Pointe Scientific Cocaine Metabolite Enzyme Immunoassay | 2020-03-12 | 267 |
| K181499 | Microgenics Corporation | DRI Cocaine Metabolite Assay | 2018-07-06 | 29 |
| K170293 | Siemens Healthcare Diagnostics, Inc. | Emit II Plus Cocaine Metabolite Assay | 2017-10-25 | 267 |
Recalls for DIO devices
23 product recalls in 11 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-08-18.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 8 |
Frequently asked questions
What is FDA product code DIO?
DIO is the FDA product code for enzyme immunoassay, cocaine and cocaine metabolites. It is a Class II device, regulated under 21 CFR 862.3250 and reviewed by the Clinical Toxicology panel.
What device class is DIO?
Class II, regulation 21 CFR 862.3250. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIO?
Across 145 cleared submissions the average was 117 days from receipt to decision (median 80).
Which companies have the most DIO clearances?
Syva Co. (9); Roche Diagnostic Systems, Inc. (9); Princeton BioMeditech Corp. (7); Abbott Laboratories (6); Guangzhou Wondfo Biotech Co., Ltd. (4).
Have DIO devices been recalled?
Yes: 23 product recalls across 11 recall events; the most recent began 2020-08-18.
Next steps
- Run an FDA pathway report with predicate devices for product code DIO
- Run a recall and safety report across every DIO manufacturer
- Watch product code DIO 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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