Cleared Traditional

K050682 - LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1)

K050682 is an FDA 510(k) clearance for LIQUICHEK URINE TOXICOLOGY CONTROL (LEV..., manufactured by Bio-Rad Laboratories, Inc.. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K050682 · Bio-Rad Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
44d
Days
Class 1
Risk

K050682 is an FDA 510(k) clearance for the LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1). Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on April 29, 2005 after a review of 44 days - a notably fast clearance cycle.

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: 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 Bio-Rad Laboratories, Inc. devices

FDA 510(k) Submission Details - K050682

510(k) Number K050682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2005
Decision Date April 29, 2005
Days to Decision 44 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
43d faster than avg
Panel avg: 87d · This submission: 44d
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 172
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K050682.
TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414
K060788 · Biosite Incorporated · Jul 2006
MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K060417 · Quantimetrix Corp. · Mar 2006
LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK
K052053 · Bio-Rad · Aug 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · Biosite Incorporated · Mar 2005
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · Bio-Rad · Nov 2004
DC-ACETA/SAL CONTROLS
K041666 · Diagnostic Chemicals , Ltd. · Aug 2004