# K023856: Visualine Methadone Dipstriptest

- Pathway: 510(k) (Traditional)
- Applicant: Sun Biomedical Laboratories, Inc.
- Decided: Aug 25, 2003 after 279 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 no predicate by number.

## Indications for use
The Visualine@Methadone Dipstrip Test is used for qualitative testing for the presence of Methadone in human urine samples at or above 300 ng/ml. This test provides only a preliminary screening result; a more specific alternative method should be used to confirm the test result. This test is intended for use by medical professionals.

Source page: https://510kreport.com/device/K023856
Methodology: https://510kreport.com/methodology