Cleared Special

K032057 - TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC

K032057 is an FDA 510(k) clearance for TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/..., manufactured by Branan Medical Corp.. The device is a Class 2 Toxicology device with product code DIO cleared through the Special 510(k) pathway after a 50-day FDA review.

K032057 · Branan Medical Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
50d
Days
Class 2
Risk

K032057 is an FDA 510(k) clearance for the TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Branan Medical Corp. (Irvine, US). The FDA issued a Cleared decision on August 21, 2003 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 - K032057

510(k) Number K032057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2003
Decision Date August 21, 2003
Days to Decision 50 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
37d faster than avg
Panel avg: 87d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

DIO Device Classification - Class 2, Special Controls

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 144
Devices cleared under the same product code (DIO) and FDA review panel - the closest regulatory comparables to K032057.
URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
K033713 · Dade Behring, Inc. · Feb 2004
RANDOX EVIDENCE
K030360 · Randox Laboratories, Ltd. · Dec 2003
AML HAIRCHECK-DT (COCAINE)
K023626 · Quest Diagnostics, Inc. · Sep 2003
EMIT II PLUS COCAINE METABOLITE ASSAY
K031512 · Dade Behring, Inc. · Jul 2003
COZART EIA COCAINE ORAL FLIUD KIT
K030234 · Cozart Bioscience , Ltd. · Apr 2003
QUICKTOX MULTIPLE DRUG DIPCARD
K023489 · Branan Medical Corp. · Dec 2002
K032057 · TOXCUP DRUG SCREEN CUP AMP/COC/MET/OPI/PCP/THC
Download PDF Branan Medical Corp.