Cleared Traditional

First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse Buprenorphine Dip Card Test, First Sign® Drug of Abuse Butalbital Cup Test, First Sign® Drug of Abuse Butalbital Dip Card Test, First Sign® Drug of Abuse Morphine Cup Test, First Sign® Drug of Abuse Morphine Dip Card Test. (K152551) - FDA 510(k) Clearance

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

K152551 · W.H.P.M., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
62d
Days
Class 2
Risk

K152551 is an FDA 510(k) clearance for the First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse B.... Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Irwindale, US). The FDA issued a Cleared decision on November 9, 2015 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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

Submission Details

510(k) Number K152551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2015
Decision Date November 09, 2015
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 89
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K152551.
Emit II Plus Oxycodone Assay
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Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
K161216 · Immunalysis Corporation · Jun 2017
CEDIA Buprenorphine II Assay
K163101 · Microgenics Corporation · Apr 2017
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive
K150606 · Siemens Healthcare Diagnostics, Inc. · Oct 2015
Wondfo CR3 Keyless Split Sample Cup
K151478 · Guangzhou Wondfo Biotech Co., Ltd. · Jul 2015
Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls
K143502 · Immunalysis Corporation · May 2015