Cleared Traditional

K142609 - CR3 Keyless Split Sample Cup Nortriptyl...

K142609 is the FDA 510(k) clearance for CR3 Keyless Split Sample Cup Nortriptyl... by Guangzhou Wondfo Biotech Co., Ltd.. It is a Class 2 Toxicology device (product code LFG) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K142609 · Guangzhou Wondfo Biotech Co., Ltd. · Toxicology device
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Dec 2014
Decision
93d
Days
Class 2
Risk

K142609 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine. Classified as Radioimmunoassay, Tricyclic Antidepressant Drugs (product code LFG), Class II - Special Controls.

Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on December 18, 2014 after a review of 93 days - within the typical 510(k) review window.

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: 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 Guangzhou Wondfo Biotech Co., Ltd. devices

Submission Details

510(k) Number K142609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2014
Decision Date December 18, 2014
Days to Decision 93 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 87d · This submission: 93d
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 Consultant

LSI International, Inc.
Joe Shia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

All 15
Devices cleared under the same product code (LFG) and FDA review panel - the closest regulatory comparables to K142609.
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EMIT NORTRIPTYLINE ASSAY
K870823 · Syva Co. · Mar 1987
EMIT DESIPRAMINE ASSAY
K861155 · Syva Co. · May 1986