# K061556: Amedica Drug Screen THC, Coc,Opi,Amp,Met,PCP,Mdma,Bar,Bzo,; Model C1010,C1015,C1020

- Pathway: 510(k) (Special)
- Applicant: Amedica Biotech, Inc.
- Decided: Jul 21, 2006 after 46 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 Amedica Drug Screen THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, MTD, TCA, PPX, OXY Test Cup is an in vitro diagnostic test for the rapid detection of THC, benzoylecgonine, morphine, amphetamine, methamphetamine, phencyclidine, MDMA, barbiturates, benzodiazepines, methadone, tricyclic antidepressants, propoxyphene and oxycodone in human urine at the following cutoff concentration: THC 11 -nor-A9-Tetrahydrocannabinol-9-carboxylic 50 ng,ml COC Benzoylecgonine 300 ng,ml OPI 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 Oxazepam 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 is needed to obtain a confirmed result.

Source page: https://510kreport.com/device/K061556
Methodology: https://510kreport.com/methodology