# K102428: Wunder Test

- Pathway: 510(k) (Traditional)
- Applicant: Hien Helen Nguyen
- Decided: Apr 18, 2012 after 601 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
A competitive binding immunoassay used for the qualitative determination of Cannabinoids in human urine. The device is visually read and intended for over-the-counter single use. The test has a cutoff of 50 nglmL of Cannabinoids. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration.and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Source page: https://510kreport.com/device/K102428
Methodology: https://510kreport.com/methodology