Cleared Traditional

K132688 - SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZ

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

K132688 · Biochemical Diagnostics, Inc. · Toxicology device
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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

FDA 510(k) Submission Details - K132688

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 87d · This submission: 110d
Pathway characteristics
Predicate-based equivalence.

DIF Device Classification - Class 1, General Controls

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 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K132688.
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K120504 · Bio-Rad Laboratories, Inc. · Mar 2012
THERMO SCIENTIFIC MAS R DOA TOTAL
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