# K992111: Verdict -II Opiates 2000

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: Dec 16, 1999 after 177 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®-II OPIATES 2000 is a one-step immunochromatographic test for the rapid, qualitative detection of opiates (morphine and/or codeine) in human urine. The test detects opiates and their major metabolites at the cut-off concentration of 2000ng/mL. It is not for over-the-counter sale. VERDICT®-II OPIATES 2000 provides 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 (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are efit ,

Source page: https://510kreport.com/device/K992111
Methodology: https://510kreport.com/methodology