Cleared Traditional

K052053 - LIQUICHEK QUALITATIVE URINE TOXICOLOGY ...

K052053 is the FDA 510(k) clearance for LIQUICHEK QUALITATIVE URINE TOXICOLOGY ... by Bio-Rad. It is a Class 1 Toxicology device (product code DIF) cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K052053 · Bio-Rad · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
11d
Days
Class 1
Risk

K052053 is an FDA 510(k) clearance for the LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on August 9, 2005 after a review of 11 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 devices

Submission Details

510(k) Number K052053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2005
Decision Date August 09, 2005
Days to Decision 11 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
76d faster than avg
Panel avg: 87d · This submission: 11d
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 146
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K052053.
DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
K062191 · Dade Behring, Inc. · Aug 2006
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 URINE TOXICOLOGY CONTROL (LEVEL C1)
K050682 · Bio-Rad Laboratories, Inc. · Apr 2005
TRIAGE TOX DRUG SCREEN CONTROLS
K050037 · Biosite Incorporated · Mar 2005
LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S)
K042865 · Bio-Rad · Nov 2004