DRI Cocaine Metabolite Assay
Device Facts
| Record ID | K181499 |
|---|---|
| Device Name | DRI Cocaine Metabolite Assay |
| Applicant | Microgenics Corporation |
| Product Code | DIO · Clinical Toxicology |
| Decision Date | Jul 6, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3250 |
| Device Class | Class 2 |
Indications for Use
The DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine at a cutoff concentration of either 150 ng/mL or 300 ng/mL. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography / Mass spectrometry (GC/MS) or Liquid chromatography/ tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Tests for cocaine metabolite cannot distinguish between abused drugs and certain prescribed medications. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.
Device Story
DRI Cocaine Metabolite Assay is a homogeneous enzyme immunoassay for detecting benzoylecgonine in human urine. Input: urine sample; Reagents: mouse monoclonal anti-benzoylecgonine antibody, G6PDH-labeled drug, substrate. Principle: competitive binding between sample drug and labeled drug for antibody sites; free drug allows labeled enzyme to interact with substrate, increasing G6PDH activity. Output: spectrophotometric measurement at 340 nm (NAD to NADH conversion) proportional to drug concentration. Used in clinical laboratories by trained professionals. Results are preliminary; require confirmation via GC/MS or LC-MS/MS. Assists clinicians in identifying potential drug abuse; supports laboratory quality control and specimen dilution for confirmation.
Clinical Evidence
Bench testing only. Precision evaluated per CLSI EP05-A3 (n=80). Accuracy compared to LC-MS/MS (n=100) showed 100% concordance. Specificity and interference studies (CLSI EP07-A2) confirmed no significant cross-reactivity with structurally unrelated compounds or physiological substances (pH, specific gravity, endogenous/exogenous compounds).
Technological Characteristics
Homogeneous enzyme immunoassay; G6PDH-labeled drug competitive binding; spectrophotometric detection at 340 nm. Reagents: mouse monoclonal anti-benzoylecgonine antibody, G6P, NAD, benzoylecgonine analog-labeled G6PDH. Liquid ready-to-use format. Storage: 2-8°C. Analyzed on clinical chemistry analyzers (e.g., Beckman Coulter AU680).
Indications for Use
Indicated for qualitative and/or semi-quantitative determination of benzoylecgonine in human urine for individuals suspected of cocaine use. Intended for use by trained professionals in clinical laboratory settings. Not for distinguishing between abused drugs and certain prescribed medications.
Regulatory Classification
Identification
A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.
Special Controls
*Classification.* Class II (special controls). A cocaine and cocaine metabolite test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
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