# K022954: Amedica Drug Screen Cocaine Test

- Pathway: 510(k) (Traditional)
- Applicant: Amedica Biotech, Inc.
- Decided: Nov 6, 2002 after 62 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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. The FDA summary names its predicate without a number.
- (no number) Rapid Cocaine Test: named in the summary without a submission number

## Indications for use
The Amedica Drug Screen Cocaine Test is an in vitro diagnostic test for the rapid detection of benzoylecgonine in human urine at a cutoff of 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/K022954
Methodology: https://510kreport.com/methodology