Product code DIF: 510(k) clearances and predicates
Product code DIF covers 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. FDA lists 202 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
202 clearances on file under product code DIF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest DIF clearances in the FDA index, with applicant and decision date:
- 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, applicant Biochemical Diagnostics, Inc., decided 2016-02-23. FDA record
- K132688, SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ, applicant Biochemical Diagnostics, Inc., decided 2013-12-16. FDA record
- K132174, MULTICHEM WBT, applicant Techno-Path Manufacturing , Ltd., decided 2013-09-20. FDA record
- K121122, DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROL, applicant Biochemical Diagnostic, Inc., decided 2012-07-03. FDA record
- K121143, LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3), applicant Bio-Rad Laboratories, decided 2012-05-18. FDA record
- K120504, LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK, applicant Bio-Rad Laboratories, Inc., decided 2012-03-27. FDA record
- K103656, THERMO SCIENTIFIC MAS R DOA TOTAL, applicant Microgenics Corporation, decided 2011-03-24. FDA record
- K093577, LIQUICHEK OPIATE CONTROL, applicant Bio-Rad Laboratories, decided 2010-03-12. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ, MULTICHEM WBT. Watch new DIF clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DIF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DIF clearances include 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.
How many 510(k) clearances use product code DIF?
202 at the time this page was generated, from openFDA records.
How do I find a predicate device under DIF?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DIF clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.