Cleared Traditional

K053032 - ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST

Also marketed or referenced as:
CATALOG# AMP001000

K053032 is an FDA 510(k) clearance for ACRO BIOTECH LLC RAPID AMPHETAMINE URIN..., manufactured by Acro Biotech, LLC. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K053032 · Acro Biotech, LLC · Toxicology device
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Feb 2006
Decision
105d
Days
Class 2
Risk

K053032 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST. Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Acro Biotech, LLC (Rancho Cucamonga, US). The FDA issued a Cleared decision on February 9, 2006 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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 Acro Biotech, LLC devices

FDA 510(k) Submission Details - K053032

510(k) Number K053032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date February 09, 2006
Days to Decision 105 days
Submission Type Traditional
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
18d slower than avg
Panel avg: 87d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 190
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K053032.
RAPIDTOX
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FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
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AMEDITECH DRUGSMARTCUP
K053175 · Ameditech, Inc. · Dec 2005
QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
K051161 · Quest Diagnostics, Inc. · Nov 2005