Cleared Traditional

ACRO BIOTECH LLC RAPID OPIATES URINE TEST (K053037) - FDA 510(k) Clearance

Also marketed or referenced as:
CATALOG# OPI00100

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K053037 · Acro Biotech, LLC · Toxicology device
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Jun 2006
Decision
231d
Days
Class 2
Risk

K053037 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID OPIATES URINE TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Acro Biotech, LLC (Rancho Cucamonga, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 231 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K053037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date June 15, 2006
Days to Decision 231 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
144d slower than avg
Panel avg: 87d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 214
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