# K080872: Amedicheck Drug Screen THC, Coc, Opi, Amp, Met, PCP, Mdma,Bar, BZ

- Pathway: 510(k) (Special)
- Applicant: Amedica Biotech, Inc.
- Decided: Aug 19, 2008 after 141 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- 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 AmediCheck Drug Screen Test THC/COC/OPI/AMP/MET/PCP/BAR/BZO/MDMA/OXY/MTD/PPX/TCA is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, barbiturates, benzodiazepines, MDMA, oxycodone, methadone, propoxyphene and tricyclic antidepressants in human urine at the following cutoff concentration: THC I l-nor-A9 -Tetrahydrocannabinol-9-carboxylic 50 ng,ml COC Benzoylecgonine 300 ng,ml ON Morphine 2000 ng,ml OPI Morphine 300 ng,ml AMP Amphetamine 1000 ng, ml MET Methamphetamine 1000 ng,ml PCP Phencyclidine 25 ng,ml MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml BAR Secobarbital 300 ng/ml BZO Oxazeparn 300 ng/ml MTD Methadone 300 ng/ml TCA Nortriptyline 1000 ng/ml PPX Propoxyphene 300 ng/ml OXY Oxycodone 300 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale. This assay provides only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the pref eiTed confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K080872
Methodology: https://510kreport.com/methodology