# K022141: Verdict-II

- Pathway: 510(k) (Special)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Jul 30, 2002 after 28 days
- Product code: DJC (Thin Layer Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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
Verdict@-IIPropoxypheneMethamphetamine-MDMAis a one-step immunochromatographictest for the rapid, qualitative detection of methamphetamine (MAMP), 3,4-methylenedioxymethylamphetamine (MDMA) and their metabolites; propoxyphene, and its main metabolite norpropoxyphene. The test detects the major metabolites of these drugs at the following cutoff concentrations: Methamphetamine (MAMF)- lOOO,ng/mL 3,4-methylenedioxymethlyamphetamine(MDMA)- 1500 ng/rnL Norpropoxyphene (Main metabolite of propoxyphene)-300 ng/mL This product is not for over-the-counter-sale Verdict@-I1provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result

Source page: https://510kreport.com/device/K022141
Methodology: https://510kreport.com/methodology