Cleared Traditional

K924476 - THE TRIAGE II (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924476 · Biosite Incorporated · Toxicology device
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Jan 1993
Decision
141d
Days
Class 2
Risk

K924476 is an FDA 510(k) clearance for the THE TRIAGE II. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on January 22, 1993 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Biosite Incorporated devices

Submission Details

510(k) Number K924476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1992
Decision Date January 22, 1993
Days to Decision 141 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 87d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 224
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