# K023252: Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020

- Pathway: 510(k) (Traditional)
- Applicant: Icn Biomedicals, Inc.
- Decided: Nov 22, 2002 after 53 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- 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) Applied Biotech Sitrestep nuDrug Screen Test Methadone: named in the summary without a submission number

## Indications for use
Rapid Methadone Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens, The presence of Methadone in human urine above a cutoff level of 300nglml can be detected. The 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 to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GUMS, must be used in order to obtain a confirmed analytical result. Rapid Methadone Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Methadone and its metabolites in human urine specimens. The presence of Methadone in human urine above a cutoff level of 300ng/ml. can be detected. The 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 to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GUMS, must be used in order to obtain a confirmed analytical result.

Source page: https://510kreport.com/device/K023252
Methodology: https://510kreport.com/methodology