Cleared Traditional

K023316 - SINGLE ANALYTE URINE DRUGS OF ABUSE CAL...

K023316 is the FDA 510(k) clearance for SINGLE ANALYTE URINE DRUGS OF ABUSE CAL... by Lin-Zhi International, Inc.. It is a Class 2 Toxicology device (product code DLJ) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K023316 · Lin-Zhi International, Inc. · Toxicology device
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Dec 2002
Decision
74d
Days
Class 2
Risk

K023316 is an FDA 510(k) clearance for the SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on December 16, 2002 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - 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 Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K023316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2002
Decision Date December 16, 2002
Days to Decision 74 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
13d faster than avg
Panel avg: 87d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 93
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K023316.
PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS
K033246 · Roche Diagnostics Corp. · Dec 2003
PRECISET DAT AMPHETAMINE CALIBRATORS
K033165 · Roche Diagnostics Corp. · Oct 2003
DRI PRIMIDONE CALIBRATORS
K023780 · Microgenics Corp. · Feb 2003
CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K021449 · Lin-Zhi International, Inc. · Jun 2002
EMIT 2000 VANCOMYCIN CALIBRATORS
K020845 · Dade Behring, Inc. · May 2002
SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS
K020769 · Lin-Zhi International, Inc. · Apr 2002