FDA product code DIF: Drug Mixture Control Materials
DIF is the FDA product code for drug mixture control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel. FDA has cleared 202 510(k) submissions under DIF, from 77 different applicants. The average 510(k) review took 52 days (median 37). FDA has posted 10 recalls for DIF devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Drug Mixture Control Materials |
| Device class | Class I |
| Regulation | 21 CFR 862.3280 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DIF clearance
Top DIF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Rad | 31 | 2005-08-09 |
| Roche Diagnostic Systems, Inc. | 14 | 1998-10-09 |
| Medical Analysis Systems, Inc. | 13 | 2003-10-09 |
| Syva Co. | 13 | 1994-01-03 |
| Utak Laboratories, Inc. | 13 | 1983-07-28 |
72 more applicants have DIF clearances. See the full list in Caduvo.
Most recent DIF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K153474 | Biochemical Diagnostics, Inc. | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series | 2016-02-23 | 83 |
| K132688 | Biochemical Diagnostics, Inc. | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | 2013-12-16 | 110 |
| K132174 | Techno-Path Manufacturing , Ltd. | MULTICHEM WBT | 2013-09-20 | 67 |
| K121122 | Biochemical Diagnostic, Inc. | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | 2012-07-03 | 81 |
| K121143 | Bio-Rad Laboratories | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | 2012-05-18 | 32 |
Recalls for DIF devices
10 product recalls in 6 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2021-11-30.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2019 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code DIF?
DIF is the FDA product code for drug mixture control materials. It is a Class I device, regulated under 21 CFR 862.3280 and reviewed by the Clinical Toxicology panel.
What device class is DIF?
Class I, regulation 21 CFR 862.3280. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DIF?
Across 202 cleared submissions the average was 52 days from receipt to decision (median 37).
Which companies have the most DIF clearances?
Bio-Rad (31); Roche Diagnostic Systems, Inc. (14); Medical Analysis Systems, Inc. (13); Syva Co. (13); Utak Laboratories, Inc. (13).
Have DIF devices been recalled?
Yes: 10 product recalls across 6 recall events; the most recent began 2021-11-30.
Next steps
- Run an FDA pathway report with predicate devices for product code DIF
- Run a recall and safety report across every DIF manufacturer
- Watch product code DIF 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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