Cleared Traditional

K081008 - BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS

K081008 is an FDA 510(k) clearance for BUPRENORPHINE ENZYME IMMUNOASSAY, manufactured by Lin-Zhi International, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K081008 · Lin-Zhi International, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
256d
Days
Class 2
Risk

K081008 is an FDA 510(k) clearance for the BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTE.... 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 December 22, 2008 after a review of 256 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K081008

510(k) Number K081008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2008
Decision Date December 22, 2008
Days to Decision 256 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
169d slower than avg
Panel avg: 87d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K081008.
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K081008 · BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS
Download PDF FDA Summary Lin-Zhi International…