Cleared Traditional

K051626 - IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS

K051626 is an FDA 510(k) clearance for IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS, manufactured by Immunalysis Corporation. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K051626

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.

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 188
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