Cleared Traditional

K053034 - ACRO BIOTECH LLC RAPID TETRAHYDROCANNAB...

Also marketed or referenced as:
CATALOG# OPI001000

K053034 is the FDA 510(k) clearance for ACRO BIOTECH LLC RAPID TETRAHYDROCANNAB... by Acro Biotech, LLC. It is a Class 2 Toxicology device (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

Submission Details

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
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.

Device Classification

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 86
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K053034.
CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
K092269 · Randox Laboratories, Ltd. · Apr 2011
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · Microgenics Corp. · Apr 2011
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K063164 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
K050936 · ACON Laboratories, Inc. · Jun 2005
ON CALL MULTI-DRUG HOME TEST CUP
K050878 · ACON Laboratories, Inc. · Jun 2005
ON CALL MULTI-DRUG HOME TEST
K050050 · ACON Laboratories, Inc. · Mar 2005