Cleared Traditional

K051578 - IMMUNALYSIS COCAINE/COCAINE METABOLITE ...

K051578 is the FDA 510(k) clearance for IMMUNALYSIS COCAINE/COCAINE METABOLITE ... by Immunalysis Corporation. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K051578 · Immunalysis Corporation · Toxicology device
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Nov 2005
Decision
157d
Days
Class 2
Risk

K051578 is an FDA 510(k) clearance for the IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on November 18, 2005 after a review of 157 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 K051578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2005
Decision Date November 18, 2005
Days to Decision 157 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
70d slower than avg
Panel avg: 87d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 82
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