Cleared Traditional

K060355 - ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000

K060355 is an FDA 510(k) clearance for ACRO BIOTECH LLC RAPID MDMA URINE TEST, manufactured by Acro Biotech, LLC. The device is a Class 2 Toxicology device with product code DJC cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K060355 · Acro Biotech, LLC · Toxicology device
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Aug 2006
Decision
175d
Days
Class 2
Risk

K060355 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000. 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 August 7, 2006 after a review of 175 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 - K060355

510(k) Number K060355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date August 07, 2006
Days to Decision 175 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
88d slower than avg
Panel avg: 87d · This submission: 175d
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 Toxicology devices follow this clearance model.

Regulatory Peers - DJC Thin Layer Chromatography, Methamphetamine

All 22
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