FDA product code · Clinical Toxicology
DIFDrug Mixture Control Materials
Product code DIF covers Drug Mixture Control Materials, a Class I device regulated under 21 CFR 862.3280. FDA has cleared 202 devices in this code. Median review time across the 202 most recent decisions is 37 days. openFDA lists 10 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 862.3280
- Review panel
- Clinical Toxicology
- Clearances
- 202
What is happening in DIF right now?
DIF (Drug Mixture Control Materials): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in DIF?
FDA has cleared 202 devices under product code DIF since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153474 | 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 | Biochemical Diagnostics, Inc. | |
| K132688 | SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ | Biochemical Diagnostics, Inc. | |
| K132174 | MULTICHEM WBT | Techno-Path Manufacturing , Ltd. | |
| K121122 | DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL | Biochemical Diagnostic, Inc. | |
| K121143 | LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3) | Bio-Rad Laboratories | |
| K120504 | LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK | Bio-Rad Laboratories, Inc. | |
| K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL | Microgenics Corporation | |
| K093577 | LIQUICHEK OPIATE CONTROL | Bio-Rad Laboratories | |
| K080085 | MAS TOX CONTROL | Thermo Fisher Scientific | |
| K080183 | CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 | Roche Diagnostics Corp. |
How long does FDA review take for DIF?
The median FDA review time for DIF is 37 days, measured across the 202 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in DIF?
openFDA lists 10 recall records against product code DIF. A recall record covers one firm's corrective action and may span many device lots.
Z-0404-2022TerminatedMEDLINE INDUSTRIES, LP - Northfield
Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.
Z-1552-2020TerminatedQUIDEL CARDIOVASCULAR INC
Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a failing control result for the AMP and mAMP tests when the control did not fail.
Z-0911-2018TerminatedOrtho-Clinical Diagnostics, Inc.
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Z-0912-2018TerminatedOrtho-Clinical Diagnostics, Inc.
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Z-0913-2018TerminatedOrtho-Clinical Diagnostics, Inc.
This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control.
Showing the 5 most recently initiated of 10. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for DIF?
MAUDE holds no adverse-event reports naming product code DIF.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
What are the predicate devices in DIF?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in DIF?
Across the 202 most recent decisions, these applicants filed most often in DIF.
| Applicant | Recent clearances |
|---|---|
| Bio-Rad | 31 |
| Roche Diagnostic Systems, Inc. | 14 |
| Medical Analysis Systems, Inc. | 13 |
| Syva Co. | 13 |
| Utak Laboratories, Inc. | 13 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DIF
Get an email the morning anything changes in DIF — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Clinical Toxicology
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.