Cleared Traditional

K981801 - ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (FDA 510(k) Clearance)

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

K981801 · Princeton BioMeditech Corp. · Toxicology device
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Aug 1998
Decision
96d
Days
Class 2
Risk

K981801 is an FDA 510(k) clearance for the ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA. Classified as U.v. Spectrometry, Tricyclic Antidepressant Drugs (product code LFH), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Princeton, US). The FDA issued a Cleared decision on August 25, 1998 after a review of 96 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.

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Submission Details

510(k) Number K981801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1998
Decision Date August 25, 1998
Days to Decision 96 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
9d slower than avg
Panel avg: 87d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFH U.v. Spectrometry, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
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.