Cleared Traditional

K023837 - LIFESIGN HOME DRUG TEST (ECSTASY/MET)

K023837 is an FDA 510(k) clearance for LIFESIGN HOME DRUG TEST (ECSTASY/MET), manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code LAF cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K023837 · Princeton BioMeditech Corp. · Toxicology device
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Sep 2003
Decision
301d
Days
Class 2
Risk

K023837 is an FDA 510(k) clearance for the LIFESIGN HOME DRUG TEST (ECSTASY/MET), STATUS STIK MET & MDMA, ACCUSIGN STIK .... Classified as Gas Chromatography, Methamphetamine (product code LAF), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on September 15, 2003 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 862.3610 - 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K023837

510(k) Number K023837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2002
Decision Date September 15, 2003
Days to Decision 301 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
214d slower than avg
Panel avg: 87d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LAF Device Classification - Class 2, Special Controls

Product Code LAF Gas Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAF Gas Chromatography, Methamphetamine

All 32
Devices cleared under the same product code (LAF) and FDA review panel - the closest regulatory comparables to K023837.
METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY
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IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS
K051577 · Immunalysis Corporation · Oct 2005
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE
K033299 · ACON Laboratories, Inc. · Dec 2003
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · ACON Laboratories, Inc. · Oct 2002
AMPHETAMINE/METHAMPHETAMINE
K012998 · Abbott Laboratories · Mar 2002
ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
K011672 · ACON Laboratories, Inc. · Jul 2001