Cleared Traditional

K012907 - LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL

K012907 is an FDA 510(k) clearance for LIQUISPX LIQUID SALIVA OR UNRINE DRUG O..., manufactured by Clinical Controls. The device is a Class 1 Chemistry device with product code DIF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K012907 · Clinical Controls · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
30d
Days
Class 1
Risk

K012907 is an FDA 510(k) clearance for the LIQUISPX LIQUID SALIVA OR UNRINE DRUG OF ABUSE CONTROL. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Clinical Controls (Hawaiian Gardens, US). The FDA issued a Cleared decision on September 28, 2001 after a review of 30 days - a notably fast clearance cycle.

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

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Controls devices

FDA 510(k) Submission Details - K012907

510(k) Number K012907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2001
Decision Date September 28, 2001
Days to Decision 30 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
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 176
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K012907.
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469
K021415 · Bio-Rad · May 2002
TRIAGE TOX DRUG SCREEN CONTROLS, CATALOG #94001
K012999 · Biosite Incorporated · Oct 2001
TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002
K013002 · Biosite Incorporated · Oct 2001
LIQUICHEK TDM CONTROL
K012741 · Bio-Rad · Sep 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · Randox Laboratories, Ltd. · Aug 2001
URINE DRUG SCREENING CONTROL
K992395 · Seracare Technology · Aug 1999