Cleared Traditional

K053035 - ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST

Also marketed or referenced as:
CATALOG# MET001000

K053035 is an FDA 510(k) clearance for ACRO BIOTECH LLC RAPID BENZOYLECGONINE ..., manufactured by Acro Biotech, LLC. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K053035

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
Combination Product No
PCCP Authorized No
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.

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 117
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