Cleared Traditional

K052197 - FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST (FDA 510(k) Clearance)

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

K052197 · W.H.P.M., Inc. · Toxicology device
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Jun 2006
Decision
301d
Days
Class 2
Risk

K052197 is an FDA 510(k) clearance for the FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by W.H.P.M., Inc. (Beverly, US). The FDA issued a Cleared decision on June 9, 2006 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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. Elevated predicate reliance profile. 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 K052197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2005
Decision Date June 09, 2006
Days to Decision 301 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
214d slower than avg
Panel avg: 87d · This submission: 301d
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 Toxicology 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 K052197.
LZI Methadone II Enzyme Immunoassay
K192433 · Lin-Zhi International, Inc. · Oct 2019
LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators
K170416 · Lin-Zhi International, Inc. · Jun 2017
Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets
K151395 · Immunalysis Corporation · Jul 2015