Cleared Traditional

K210327 - First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup (FDA 510(k) Clearance)

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

K210327 · W.H.P.M., Inc. · Toxicology device
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Aug 2021
Decision
189d
Days
Class 2
Risk

K210327 is an FDA 510(k) clearance for the First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Si.... Classified as Test, Propoxyphene, Over The Counter (product code QBF), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on August 12, 2021 after a review of 189 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3700 - 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 W.H.P.M., Inc. devices

Submission Details

510(k) Number K210327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2021
Decision Date August 12, 2021
Days to Decision 189 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
102d slower than avg
Panel avg: 87d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBF Test, Propoxyphene, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3700
Definition The Propoxyphene Test Is An In Vitro Diagnostic Test For The Qualitative Detection Of Propoxyphene In Human Urine. The Test Is Intended For Over-the-counter Use As The First Step In A Two Step Process To Provide Consumers With Information Concerning The Presence Or Absence Of Propoxyphene In A Urine Sample.
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 Consulting
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.