Cleared Special

K061556 - AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,

Also marketed or referenced as:
MODEL C1010,C1015,C1020

K061556 is an FDA 510(k) clearance for AMEDICA DRUG SCREEN THC, manufactured by Amedica Biotech, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Special 510(k) pathway after a 46-day FDA review.

K061556 · Amedica Biotech, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
46d
Days
Class 2
Risk

K061556 is an FDA 510(k) clearance for the AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Amedica Biotech, Inc. (Hayward, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K061556

510(k) Number K061556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2006
Decision Date July 21, 2006
Days to Decision 46 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 87d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K061556.
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
K080467 · Applied Dna Technologies, Inc. · Nov 2008
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
K080872 · Amedica Biotech, Inc. · Aug 2008
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
ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST
K053034 · Acro Biotech, LLC · Jun 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
K061556 · AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,
Download PDF Amedica Biotech, Inc.