# K031497: Amedica Drug Screen Mdma-Bar-Bzo-MTD-Tca Test

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Biotech, Inc.
- Decided: Oct 17, 2003 after 157 days
- Product code: DJC (Thin Layer Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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.
- (no number) Instant-View Drug Screen MDMA, Barbiturate, Benzodiazepine, Methadone, TCA Test: named in the summary without a submission number

## Indications for use
The Amedica Drug Screen MDMA-BAR-BZO-MTD-TCA Test is an in vitro diagnostic test for the rapid detection of 3,4 methylenedioxymethamphetamine, secobarbital, oxazepam, methadone and nortriptyline in human urine at the following cut-off concentration. MDMA 3,4 methylenedioxymethamphetamine 500 ng/ml BAR secobarbital 300 ng/ml RZO oxazepam 300 ng/ml MTD methadone 300 ng/ml TCA nortriptyline 1000 ng/ml This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not for over-the-counter sale.

Source page: https://510kreport.com/device/K031497
Methodology: https://510kreport.com/methodology