Cleared Traditional

K001126 - PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST

K001126 is an FDA 510(k) clearance for PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST, manufactured by Alatex Scientific, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K001126 · Alatex Scientific, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
122d
Days
Class 2
Risk

K001126 is an FDA 510(k) clearance for the PEACE OF MIND MULTIPLE DRUGS OF ABUSE TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Alatex Scientific, Inc. (Mountian View, US). The FDA issued a Cleared decision on August 7, 2000 after a review of 122 days - within the typical 510(k) review window.

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 Alatex Scientific, Inc. devices

FDA 510(k) Submission Details - K001126

510(k) Number K001126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2000
Decision Date August 07, 2000
Days to Decision 122 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
35d slower than avg
Panel avg: 87d · This submission: 122d
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 125
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K001126.
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
PROFILE II ER
K010138 · Medtox Diagnostics, Inc. · Feb 2001
STC CANNABINOIDS INTERCEPT MICRO-PLATE EIA, MODEL 1118I
K002375 · OraSure Technologies, Inc. · Jan 2001
FIRST CHECK HOME DRUG TEST (THC)
K993663 · Worldwide Medical Corp. · Jun 2000
FIRST CHECK HOME DRUG TEST PANEL 3
K994138 · Worldwide Medical Corp. · Jun 2000
FIRST CHECK HOME DRUG TEST PANEL 2
K994139 · Worldwide Medical Corp. · Jun 2000