Cleared Traditional

K053035 - ACRO BIOTECH LLC RAPID BENZOYLECGONINE ...

Also marketed or referenced as:
CATALOG# MET001000

K053035 is the FDA 510(k) clearance for ACRO BIOTECH LLC RAPID BENZOYLECGONINE ... by Acro Biotech, LLC. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K053035 · Acro Biotech, LLC · Toxicology device
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May 2006
Decision
190d
Days
Class 2
Risk

K053035 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Acro Biotech, LLC (Rancho Cucamonga, US). The FDA issued a Cleared decision on May 5, 2006 after a review of 190 days - an extended review cycle.

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

Submission Details

510(k) Number K053035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date May 05, 2006
Days to Decision 190 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 87d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 83
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