Cleared Traditional

K053034 - ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST

Also marketed or referenced as:
CATALOG# OPI001000

K053034 is an FDA 510(k) clearance for ACRO BIOTECH LLC RAPID TETRAHYDROCANNAB..., manufactured by Acro Biotech, LLC. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K053034 · Acro Biotech, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
222d
Days
Class 2
Risk

K053034 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Acro Biotech, LLC (Rancho Cucamonga, US). The FDA issued a Cleared decision on June 6, 2006 after a review of 222 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 - K053034

510(k) Number K053034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2005
Decision Date June 06, 2006
Days to Decision 222 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 87d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 125
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K053034.
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