FDA product code DLZ: Enzyme Immunoassay, Phenobarbital
DLZ is the FDA product code for enzyme immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel. FDA has cleared 35 510(k) submissions under DLZ, from 23 different applicants. The average 510(k) review took 76 days (median 56). FDA has posted 9 recalls for DLZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Phenobarbital |
| Device class | Class II |
| Regulation | 21 CFR 862.3660 |
| 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 DLZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 143 |
Compare with all 510(k) review times · Search every DLZ clearance
Top DLZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 8 | 2001-06-06 |
| Abbott Laboratories | 3 | 2008-09-26 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2021-08-13 |
| Instrumentation Laboratory CO | 2 | 1995-01-18 |
| Em Diagnostic Systems, Inc. | 2 | 1987-01-07 |
18 more applicants have DLZ clearances. See the full list in Caduvo.
Most recent DLZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210858 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products PHBR Slides | 2021-08-13 | 143 |
| K123271 | Microgenics Corp. | ABBOTT PHENOBARBITAL ASSAY | 2013-04-26 | 189 |
| K081231 | Abbott Laboratories | ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 | 2008-09-26 | 148 |
| K071644 | Roche Diagnostics Corp. | ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 | 2007-09-12 | 89 |
| K011303 | Randox Laboratories, Ltd. | RANDOX PHENOBARBITAL | 2001-07-02 | 63 |
Recalls for DLZ devices
9 product recalls in 9 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-08-30.
Frequently asked questions
What is FDA product code DLZ?
DLZ is the FDA product code for enzyme immunoassay, phenobarbital. It is a Class II device, regulated under 21 CFR 862.3660 and reviewed by the Clinical Toxicology panel.
What device class is DLZ?
Class II, regulation 21 CFR 862.3660. Typical premarket route: 510(k).
How long does a 510(k) take for product code DLZ?
Across 35 cleared submissions the average was 76 days from receipt to decision (median 56).
Which companies have the most DLZ clearances?
Syva Co. (8); Abbott Laboratories (3); Ortho-Clinical Diagnostics, Inc. (2); Instrumentation Laboratory CO (2); Em Diagnostic Systems, Inc. (2).
Have DLZ devices been recalled?
Yes: 9 product recalls across 9 recall events; the most recent began 2013-08-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DLZ
- Run a recall and safety report across every DLZ manufacturer
- Watch product code DLZ 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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