Cleared Traditional

K043242 - TRIAGE TOX DRUG SCREEN

K043242 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 LDP cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K043242 · Biosite Incorporated · Toxicology device
Download Printable Device Report (PDF)
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Feb 2005
Decision
97d
Days
Class 2
Risk

K043242 is an FDA 510(k) clearance for the TRIAGE TOX DRUG SCREEN. Classified as Colorimetry, Acetaminophen (product code LDP), Class II - Special Controls.

Submitted by Biosite Incorporated (San Diego, US). The FDA issued a Cleared decision on February 28, 2005 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3030 - 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 - K043242

510(k) Number K043242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2004
Decision Date February 28, 2005
Days to Decision 97 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
10d slower than avg
Panel avg: 87d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDP Device Classification - Class 2, Special Controls

Product Code LDP Colorimetry, Acetaminophen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3030
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 - LDP Colorimetry, Acetaminophen

All 31
Devices cleared under the same product code (LDP) and FDA review panel - the closest regulatory comparables to K043242.
ROCHE ACETAMINOPHEN ASSAY
K110726 · Roche Diagnostics · Dec 2011
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
K100200 · Siemens Healthcare Diagnostics · Aug 2010
DIMENSION VISTA FLEX REAGENT CARTRIDGES
K061655 · Dade Behring, Inc. · Jul 2006
ACETAMINOPHEN-SL ASSAY
K042330 · Diagnostic Chemicals , Ltd. · Jan 2005
ACETAMINOPHEN ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K020792 · Bayer Diagnostics Corp. · Jul 2002
ROCHE ACETAMINOPHEN
K013757 · Roche Diagnostics Corp. · Jan 2002