Cleared Traditional

K052197 - FIRST SIGN DRUG OF ABUSE URINE SCREENIN...

K052197 is an FDA 510(k) clearance for FIRST SIGN DRUG OF ABUSE URINE SCREENIN..., manufactured by W.H.P.M., Inc.. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K052197 · W.H.P.M., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K052197

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.

DJR Device Classification - Class 2, Special Controls

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 52
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K052197.
DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLS
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K060791 · Biosite Incorporated · Jun 2006
METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS
K051058 · Lin-Zhi International, Inc. · Mar 2006
RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd. · May 2004
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797 · Lin-Zhi International, Inc. · Oct 2003