# K031032: Verdict II, Profile II

- Pathway: 510(k) (Special)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Jul 14, 2003 after 104 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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@-IITHC/COC/OPI/MAMP-MDMA is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids, opiates, cocaine, methamphetamine (MAMP), and 3,4-methylenedioxymethylamphetamine(MDMA) and their metabolites. The test detects the major metabolites of these drugs at the following cutoff concentrations: Cannabinoids (1 1 nor-9-carboxy-Ag-THC)-50ng/ml Opiates (morphine)-300 ng/ml Cocaine (benzoy1ecgonine)-300 ng/mL Methamphetamine (MAMP)-1000 ng/mL 3,4-methylenedioxymethiyamphetamine(MDMA)- 1500 ng/mL, This product is not for over-the-counter-sale Verdict@-11provides 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/K031032
Methodology: https://510kreport.com/methodology