Cleared Traditional

K051058 - METHADONE ORAL FLUID HOMOGENEOUS ENZYME...

K051058 is the FDA 510(k) clearance for METHADONE ORAL FLUID HOMOGENEOUS ENZYME... by Lin-Zhi International, Inc.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K051058 · Lin-Zhi International, Inc. · Toxicology device
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Mar 2006
Decision
337d
Days
Class 2
Risk

K051058 is an FDA 510(k) clearance for the METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Lin-Zhi International, Inc. devices

Submission Details

510(k) Number K051058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2005
Decision Date March 29, 2006
Days to Decision 337 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
250d slower than avg
Panel avg: 87d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 47
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K051058.
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
K081378 · Thermo Fisher Scientific · Jan 2009
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
TRIAGE TOX DRUG SCREEN, MODEL 94400
K060791 · Biosite Incorporated · Jun 2006
RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd. · May 2004
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797 · Lin-Zhi International, Inc. · Oct 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · Microgenics Corp. · Aug 2003