Cleared Traditional

K061457 - UCP RAPID DRUG SCREENING TRICYCLIC ANTI...

K061457 is the FDA 510(k) clearance for UCP RAPID DRUG SCREENING TRICYCLIC ANTI... by Ucp Biosciences, Inc.. It is a Class 2 Toxicology device (product code LFG) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K061457 · Ucp Biosciences, Inc. · Toxicology device
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Aug 2006
Decision
88d
Days
Class 2
Risk

K061457 is an FDA 510(k) clearance for the UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS. Classified as Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG), Class II - Special Controls.

Submitted by Ucp Biosciences, Inc. (San Jose, US). The FDA issued a Cleared decision on August 21, 2006 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3910 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ucp Biosciences, Inc. devices

Submission Details

510(k) Number K061457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2006
Decision Date August 21, 2006
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 87d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.
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 - LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

All 16
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