FDA product code DIS: Enzyme Immunoassay, Barbiturate
DIS is the FDA product code for enzyme immunoassay, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. FDA has cleared 100 510(k) submissions under DIS, from 48 different applicants. The average 510(k) review took 97 days (median 62). FDA has posted 7 recalls for DIS devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Barbiturate |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| 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 DIS clearance
Top DIS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 13 | 1995-02-22 |
| Abbott Laboratories | 7 | 2002-03-20 |
| Roche Diagnostic Systems, Inc. | 6 | 1999-05-03 |
| Princeton BioMeditech Corp. | 6 | 1999-04-15 |
| Medtox Diagnostics, Inc. | 4 | 2003-11-10 |
43 more applicants have DIS clearances. See the full list in Caduvo.
Most recent DIS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K161714 | Immunalysis Corporation | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | 2016-10-14 | 115 |
| K151211 | Assure Tech. Co., Ltd. | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup | 2015-06-04 | 29 |
| K150791 | Healgen Scientific,, LLC | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) | 2015-04-24 | 30 |
| K143535 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 Keyless Split Sample Cup Secobarbital- Methadone | 2015-01-13 | 29 |
| K140665 | Genprime, Inc. | GenPrime Snap-Top Split Key Cup | 2014-12-08 | 265 |
Recalls for DIS devices
7 product recalls in 5 recall events; 0 initiated in the last five years and 3 still open. Most recent: 2019-06-12.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code DIS?
DIS is the FDA product code for enzyme immunoassay, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is DIS?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
How long does a 510(k) take for product code DIS?
Across 100 cleared submissions the average was 97 days from receipt to decision (median 62).
Which companies have the most DIS clearances?
Syva Co. (13); Abbott Laboratories (7); Roche Diagnostic Systems, Inc. (6); Princeton BioMeditech Corp. (6); Medtox Diagnostics, Inc. (4).
Have DIS devices been recalled?
Yes: 7 product recalls across 5 recall events; the most recent began 2019-06-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DIS
- Run a recall and safety report across every DIS manufacturer
- Watch product code DIS 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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