Cleared Traditional

K142353 - First Sign Drug of Abuse Dip Card Test/...

K142353 is an FDA 510(k) clearance for First Sign Drug of Abuse Dip Card Test/..., manufactured by W.H.P.M., Inc.. The device is a Class 2 Toxicology device with product code DIO cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K142353 · W.H.P.M., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
47d
Days
Class 2
Risk

K142353 is an FDA 510(k) clearance for the First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on October 7, 2014 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 W.H.P.M., Inc. devices

FDA 510(k) Submission Details - K142353

510(k) Number K142353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2014
Decision Date October 07, 2014
Days to Decision 47 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
40d faster than avg
Panel avg: 87d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 96
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