Cleared Traditional

K063024 - LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOM...

K063024 is the FDA 510(k) clearance for LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOM... by Lin-Zhi International, Inc.. It is a Class 2 Chemistry device (product code DKZ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K063024 · Lin-Zhi International, Inc. · Chemistry device
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Oct 2006
Decision
28d
Days
Class 2
Risk

K063024 is an FDA 510(k) clearance for the LZI AMPHETAMINE-SPECIFIC ORAL FLUID HOMOGENEOUS ENZTME IMMUNOASSAY: LZI AMPHE.... Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on October 30, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3100 - 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 Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K063024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date October 30, 2006
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 Chemistry devices follow this clearance model.

Regulatory Peers - DKZ Enzyme Immunoassay, Amphetamine

All 125
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K063024.
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010
VITROS CHEMISTRY PRODUCTS AMPH REAGENT
K062077 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109
K053337 · Dade Behring, Inc. · May 2006
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · Immunalysis Corporation · Oct 2005
EMIT II PLUS ECSTASY ASSAY
K043028 · Dade Behring, Inc. · Jan 2005