ONE STEP Methadone (MTD) Test

Trade name

ONE STEP Methadone (MTD) Test

06936155803927

B-06936155803927

Reference / catalog number

ITP06008-TC40

GS1

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The One Step Methadone (MTD) Test is a rapid, qualitative immunoassay for the determination of methadone and its metabolite in human urine. The test is used to screen urine for the presence of methadone. The test is for use by healthcare professionals only. This test 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 spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. Methadone is a prescription drug that can also be abused and may be excreted in urine in unchanged forms and metabolites. The test is based on competitive immunochemical reactions between methadone or its metabolite in the specimen and drug conjugate for limited antibody binding sites. When methadone is present at or above the cutoff level, the test line does not develop and only the control line appears, indicating a positive result. A negative specimen produces both a test line and a control line. The control line indicates that sufficient sample volume has been added and that the reagents are functioning properly.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102160599DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER

4 warnings recorded — scroll inside the panel to see all entries.

• CW011

  For professional in vitro diagnostic use only. This product is designed for detection of methadone in human urine only and provides a preliminary qualitative screening result only. Positive results should be confirmed using an alternate method, preferably GC/MS, and clinical considerations and professional judgment should be applied. The test is not suggested for determining the quantitative methadone level in urine and does not indicate the level of intoxication or monitor drug levels. Avoid cross-contamination of urine samples by using a new urine specimen cup for each sample, and do not interpret results after 8 minutes.
• CW010

  Read and follow the package insert carefully before use.
• CW008

  Read and follow the package insert carefully before use.
• CW032

  Do not use the kit beyond the expiration date printed on the outside of the foil pouch.