Cleared Traditional

K090844 - BUPRENORPHINE ENZYME IMMUNOASSAY WITH N...

K090844 is the FDA 510(k) clearance for BUPRENORPHINE ENZYME IMMUNOASSAY WITH N... by Lin-Zhi International, Inc.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K090844 · Lin-Zhi International, Inc. · Toxicology device
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Jul 2009
Decision
125d
Days
Class 2
Risk

K090844 is an FDA 510(k) clearance for the BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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. Standard predicate reliance. 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 K090844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2009
Decision Date July 30, 2009
Days to Decision 125 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
38d slower than avg
Panel avg: 87d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
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