Cleared Traditional

K102210 - LZI AMPHETAMINES 500 HOMOGENOUS ENZYME ...

Also marketed or referenced as:
LZI AMPHETAMINES 500 CALIBRATORS LZI AMPHETAMINES 500 CONTROLS

K102210 is the FDA 510(k) clearance for LZI AMPHETAMINES 500 HOMOGENOUS ENZYME ... by Lin-Zhi International, Inc.. It is a Class 2 Chemistry device (product code DKZ) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K102210 · Lin-Zhi International, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
145d
Days
Class 2
Risk

K102210 is an FDA 510(k) clearance for the LZI AMPHETAMINES 500 HOMOGENOUS ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on December 28, 2010 after a review of 145 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K102210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2010
Decision Date December 28, 2010
Days to Decision 145 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
57d slower than avg
Panel avg: 88d · This submission: 145d
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 K102210.
ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID
K110446 · Roche Diagnostics · May 2011
THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY
K101745 · Microgenics Corp. · Apr 2011
RANDOX ECSTASY (MDMA) ASSAY
K092275 · Randox Laboratories, Ltd. · Mar 2011
AMPHETAMINES II ASSAY
K093664 · Roche Diagnostics Corp. · Jul 2010
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY
K093114 · Microgenics Corp. · May 2010
AMPHETAMINES II
K083764 · Roche Diagnostics Corp. · Feb 2010