Cleared Traditional

K053033 - ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST

Also marketed or referenced as:
CATALOG# MET001000

K053033 is an FDA 510(k) clearance for ACRO BIOTECH LLC RAPID METHAMPHETAMINE ..., manufactured by Acro Biotech, LLC. The device is a Class 2 Chemistry device with product code DJC cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K053033 · Acro Biotech, LLC · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
222d
Days
Class 2
Risk

K053033 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), 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 Chemistry FDA review panel, regulated under 21 CFR 862.3610 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K053033

510(k) Number K053033 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 Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 89d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJC Device Classification - Class 2, Special Controls

Product Code DJC Thin Layer Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJC Thin Layer Chromatography, Methamphetamine

All 30
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K053033 · ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
Download PDF FDA Summary Acro Biotech, LLC