Cleared Traditional

K014193 - LIFESIGN DOA 4 (THC/OPI/COC/MET)

K014193 is an FDA 510(k) clearance for LIFESIGN DOA 4 (THC/OPI/COC/MET), manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K014193 · Princeton BioMeditech Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
153d
Days
Class 2
Risk

K014193 is an FDA 510(k) clearance for the LIFESIGN DOA 4 (THC/OPI/COC/MET). Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on May 23, 2002 after a review of 153 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K014193

510(k) Number K014193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2001
Decision Date May 23, 2002
Days to Decision 153 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
66d slower than avg
Panel avg: 87d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 94
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K014193.
ONLINE DAT II CANNABINOIDS II
K030213 · Roche Diagnostics Corp. · Apr 2003
CANNABINOID ENZYME IMMUNOASSAY, CATALOG 0070, 0071
K021887 · Lin-Zhi International, Inc. · Aug 2002
LIFESIGN THC, STATUS STIK THC, ACCUSIGN STIK THC, LIFESIGN MARIJUANA, ACCUSTIK THC
K014066 · Princeton BioMeditech Corp. · Jun 2002
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · OraSure Technologies, Inc. · Jan 2001