FDA product code DKZ: Enzyme Immunoassay, Amphetamine
DKZ is the FDA product code for enzyme immunoassay, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel. FDA has cleared 225 510(k) submissions under DKZ, 3 in the last five years, from 87 different applicants. The average 510(k) review took 111 days (median 76); 233 days on average over the last three years. FDA has posted 24 recalls for DKZ devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Amphetamine |
| Device class | Class II |
| Regulation | 21 CFR 862.3100 |
| 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 DKZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 158 |
| 2019 | 3 | 202 |
| 2020 | 1 | 26 |
| 2023 | 2 | 55 |
| 2024 | 1 | 233 |
Compare with all 510(k) review times · Search every DKZ clearance
Top DKZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 17 | 1998-12-11 |
| Syva Co. | 13 | 2001-08-03 |
| Ucp Biosciences, Inc. | 9 | 2016-05-03 |
| Roche Diagnostics Corp. | 9 | 2010-07-28 |
| American Bio Medica Corp. | 9 | 2006-05-25 |
82 more applicants have DKZ clearances. See the full list in Caduvo.
Most recent DKZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240670 | Microgenics Corporation | DRI Ecstasy Plus Assay | 2024-10-30 | 233 |
| K233019 | Hangzhou AllTest Biotech Co., Ltd. | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | 2023-12-13 | 82 |
| K231137 | Xenta Biomedical Science Co., Ltd. | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | 2023-05-19 | 28 |
| K200363 | Quidel Cardiovascular, Inc. | Quidel Triage® TOX Drug Screen, 94600 | 2020-03-11 | 26 |
| K191099 | Atlas Medical | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | 2019-10-03 | 161 |
Recalls for DKZ devices
24 product recalls in 15 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-25.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2020 | 3 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code DKZ?
DKZ is the FDA product code for enzyme immunoassay, amphetamine. It is a Class II device, regulated under 21 CFR 862.3100 and reviewed by the Clinical Toxicology panel.
What device class is DKZ?
Class II, regulation 21 CFR 862.3100. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKZ?
Across 225 cleared submissions the average was 111 days from receipt to decision (median 76).
Which companies have the most DKZ clearances?
Roche Diagnostic Systems, Inc. (17); Syva Co. (13); Ucp Biosciences, Inc. (9); Roche Diagnostics Corp. (9); American Bio Medica Corp. (9).
Have DKZ devices been recalled?
Yes: 24 product recalls across 15 recall events; the most recent began 2022-05-25.
Next steps
- Run an FDA pathway report with predicate devices for product code DKZ
- Run a recall and safety report across every DKZ manufacturer
- Watch product code DKZ 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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