# K100108: Amedica Drug Test THC, Coc, Opi,  Amp, Met, PCP, Bar, Bzo, Mdma, Oxy, Tca

- Pathway: 510(k) (Special)
- Applicant: Amedica Biotech, Inc.
- Decided: Apr 14, 2010 after 90 days
- Product code: NGL (Test, Opiates, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Amedica Drug Screen Test THC/COC/OPL/AMP/MET/PCP/MDMA/BARIBZO/MTD/TCA/OXY is an in vitro diagnostic test for the rapid detection of the following drugs in human urine THC 1 1-nor-A⁹-Tetrahydrocannabinol-9-carboxylic 50 ng/mI COC Benzoyiecgonine 300 ng/mI OPI Morphine 300 ng/ml OPI Morphine 2000 ng/ml AMP Amphetamine 1000 ng/ml MET Methamphetamine 1000 ng/ml PCP Phencyclidine 25 ng/ml MDMA 3,4 methylenedioxymethamphetamine 500 nglml BAR Secobarbital 300 ng/ml BZO Oxazepam 300 ng/mI MTD Methadone 300 ng/ml TCA Nortriptyline 1000 ng/ml OXY Oxycodone 300 ng/ml This test is intended for use by over-the-counter (OTC) consumers as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Tests for prescription drugs will yield preliminary positive results when prescription drugs are ingested, even at or above therapeutic doses. There are no uniformly recognized drug cutoffs for barbiturates, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Source page: https://510kreport.com/device/K100108
Methodology: https://510kreport.com/methodology