Cleared Traditional

K051626 - IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS

K051626 is the FDA 510(k) clearance for IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS by Immunalysis Corporation. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K051626 · Immunalysis Corporation · Toxicology device
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Oct 2005
Decision
115d
Days
Class 2
Risk

K051626 is an FDA 510(k) clearance for the IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 13, 2005 after a review of 115 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 Immunalysis Corporation devices

Submission Details

510(k) Number K051626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2005
Decision Date October 13, 2005
Days to Decision 115 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 87d · This submission: 115d
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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K043507 · ACON Laboratories, Inc. · Feb 2005
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K041144 · Randox Laboratories, Ltd. · Nov 2004