Cleared Traditional

K132688 - SALIVABUSE LIQUID ORAL FLUID CONTROL

K132688 is the FDA 510(k) clearance for SALIVABUSE LIQUID ORAL FLUID CONTROL by Biochemical Diagnostics, Inc.. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K132688 · Biochemical Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
110d
Days
Class 1
Risk

K132688 is an FDA 510(k) clearance for the SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, A.... Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Biochemical Diagnostics, Inc. (Edgewood, US). The FDA issued a Cleared decision on December 16, 2013 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biochemical Diagnostics, Inc. devices

Submission Details

510(k) Number K132688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2013
Decision Date December 16, 2013
Days to Decision 110 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 87d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIF Drug Mixture Control Materials

All 147
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K132688.
LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)
K121143 · Bio-Rad Laboratories · May 2012
LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK
K120504 · Bio-Rad Laboratories, Inc. · Mar 2012
LIQUICHEK OPIATE CONTROL
K093577 · Bio-Rad Laboratories · Mar 2010
MAS TOX CONTROL
K080085 · Thermo Fisher Scientific · Apr 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500
K080183 · Roche Diagnostics Corp. · Mar 2008
ESA LEADCARE II LEAD CONTROL
K063398 · Bionostics, Inc. · Dec 2006