Cleared Traditional

K031497 - AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST

K031497 is an FDA 510(k) clearance for AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TC..., manufactured by Amedica Biotech, Inc.. The device is a Class 2 Toxicology device with product code DJC cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K031497 · Amedica Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
157d
Days
Class 2
Risk

K031497 is an FDA 510(k) clearance for the AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST. Classified as Thin Layer Chromatography, Methamphetamine (product code DJC), Class II - Special Controls.

Submitted by Amedica Biotech, Inc. (Hayward, US). The FDA issued a Cleared decision on October 17, 2003 after a review of 157 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 Amedica Biotech, Inc. devices

FDA 510(k) Submission Details - K031497

510(k) Number K031497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2003
Decision Date October 17, 2003
Days to Decision 157 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
70d slower than avg
Panel avg: 87d · This submission: 157d
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 23
Devices cleared under the same product code (DJC) and FDA review panel - the closest regulatory comparables to K031497.
ACRO BIOTECH LLC RAPID MDMA URINE TEST, CATALOG MDMA0010000
K060355 · Acro Biotech, LLC · Aug 2006
MODIFICATION TO ONTRAK TESTCUP II AND ONSITE CUPKIT
K060896 · Varian, Inc. · Jun 2006
ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST
K053033 · Acro Biotech, LLC · Jun 2006
INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST
K022501 · Alfa Scientific Designs, Inc. · Nov 2002
VERDICT-II
K022141 · Medtox Diagnostics, Inc. · Jul 2002
RAPIDONE-ECSTASY TEST
K013180 · American Bio Medica Corp. · Nov 2001