Cleared Traditional

K151441 - First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test (FDA 510(k) Clearance)

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

K151441 · W.H.P.M., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
31d
Days
Class 2
Risk

K151441 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, Methadone (product code DJR), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on June 29, 2015 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3620 - 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: 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

Submission Details

510(k) Number K151441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2015
Decision Date June 29, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJR Enzyme Immunoassay, Methadone

All 62
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K151441.
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