Cleared Special

K012541 - MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET

K012541 is an FDA 510(k) clearance for MODIFICATION TO:FASTIX THC/COC DRUG SCR..., manufactured by Branan Medical Corp.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Special 510(k) pathway after a 28-day FDA review.

K012541 · Branan Medical Corp. · Toxicology device
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Sep 2001
Decision
28d
Days
Class 2
Risk

K012541 is an FDA 510(k) clearance for the MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET .... Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on September 4, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K012541

510(k) Number K012541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date September 04, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 87d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K012541.
CANNABINOIDS
K013247 · Abbott Laboratories · Mar 2002
NO STEP ON SITE DEUG TEST CUP
K012390 · Drug Free Enterprises · Dec 2001
AMEDITECH IMMUTEST DRUG SCREEN THC
K011813 · Ameditech, Inc. · Oct 2001
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · Advantage Diagnostics Corp. · Jun 2001
EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
K011300 · Syva Co., Dade Behring, Inc. · May 2001
ACON THC ONE STEP MARIJUANA TEST STRIP(URINE)
K003557 · ACON Laboratories, Inc. · Mar 2001
K012541 · MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET
Download PDF Branan Medical Corp.