Cleared Traditional

K060791 - TRIAGE TOX DRUG SCREEN, MODEL 94400

K060791 is an FDA 510(k) clearance for TRIAGE TOX DRUG SCREEN, manufactured by Biosite Incorporated. The device is a Class 2 Toxicology device with product code DJR cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K060791 · Biosite Incorporated · Toxicology device
Download Printable Device Report (PDF)
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Jun 2006
Decision
91d
Days
Class 2
Risk

K060791 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN, MODEL 94400. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on June 22, 2006 after a review of 91 days - within the typical 510(k) review window.

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. 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 Biosite Incorporated devices

FDA 510(k) Submission Details - K060791

510(k) Number K060791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2006
Decision Date June 22, 2006
Days to Decision 91 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
4d slower than avg
Panel avg: 87d · This submission: 91d
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 58
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K060791.
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP
K092048 · Biosite Incorporated · Apr 2010
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K081378 · Thermo Fisher Scientific · Jan 2009
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
K062637 · Ortho-Clinical Diagnostics, Inc. · Nov 2006
FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST
K052197 · W.H.P.M., Inc. · 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