# K023648: Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine, Cannabinoids, Morphine, Methamphetami

- Pathway: 510(k) (Traditional)
- Applicant: Sun Biomedical Laboratories, Inc.
- Decided: May 6, 2003 after 188 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. The FDA summary names no predicate by number.

## Indications for use
The Visualine Cup VI for Drugs of Abuse Test is used for qualitative testing for the presence of Cocaine and it's metabolites at or above 300 ng/ml, Cannabinoids and it's metabolites at or above 50 ng/ml, Morphine and it's metabolites at or above 300 ng/ml, Methamphetamine at or above 1,000 ng/ml, Amphetamine at or above 1,000 ng/ml, Phencyclidine at or above 25 ng/ml, and Benzodiazepines and it's metabolites at or above 300 ng/ml in human urine samples. 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/K023648
Methodology: https://510kreport.com/methodology