ONE STEP Cocaine (COC) Test

Trade name

ONE STEP Cocaine (COC) Test

06936155806881

B-06936155806881

Reference / catalog number

ITP06004-DS50

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

One Step Cocaine (COC) Test is a rapid, qualitative immunoassay for the determination of benzoylecgonine, the major metabolite of cocaine, in human urine. The test is used to screen urine for the presence of benzoylecgonine. 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. Cocaine is derived from the leaves of the coca plant and is a potent central nervous system stimulant and local anesthetic. Cocaine is metabolized and excreted in urine mainly as benzoylecgonine, which may be detected after cocaine exposure. The test is a qualitative visual screening immunoassay based on a competitive binding principle. Benzoylecgonine in the urine competes with drug conjugate immobilized on the membrane for limited antibody binding sites. A negative specimen produces two colored bands, while a positive specimen produces only one control band. The control band 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.

• W0102160506COCAINE + COCAINE METABOLITES - RT & POC

3 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 benzoylecgonine 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 cocaine 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.
• CW032

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