Cleared Traditional

K050465 - IMMUNALYSIS COCAINE ELISA FOR HAIR

K050465 is the FDA 510(k) clearance for IMMUNALYSIS COCAINE ELISA FOR HAIR by Immunalysis Corporation. It is a Class 2 Chemistry device (product code DIO) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K050465 · Immunalysis Corporation · Chemistry device
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Aug 2005
Decision
154d
Days
Class 2
Risk

K050465 is an FDA 510(k) clearance for the IMMUNALYSIS COCAINE ELISA FOR HAIR. 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 August 4, 2005 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3250 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunalysis Corporation devices

Submission Details

510(k) Number K050465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2005
Decision Date August 04, 2005
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 88d · This submission: 154d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 82
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K050465.
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URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
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