Cleared Traditional

K062565 - STATUS DS NICOTINE

K062565 is an FDA 510(k) clearance for STATUS DS NICOTINE, manufactured by Princeton BioMeditech Corp.. The device is a Class 1 Chemistry device with product code MKU cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K062565 · Princeton BioMeditech Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
173d
Days
Class 1
Risk

K062565 is an FDA 510(k) clearance for the STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE. Classified as Enzyme Immunoassay, Nicotine And Nicotine Metabolites (product code MKU), Class I - General Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 20, 2007 after a review of 173 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3220 - 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K062565

510(k) Number K062565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date February 20, 2007
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
Pathway characteristics
Predicate-based equivalence.

MKU Device Classification - Class 1, General Controls

Product Code MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3220
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MKU Enzyme Immunoassay, Nicotine And Nicotine Metabolites

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