DRI Cocaine Metabolite Assay

K211973 · Microgenics Corporation · DIO · Sep 24, 2021 · Clinical Toxicology

Device Facts

• Record ID: K211973
• Device Name: DRI Cocaine Metabolite Assay
• Applicant: Microgenics Corporation
• Product Code: DIO · Clinical Toxicology
• Decision Date: Sep 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The Alinity c Cocaine 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 on the Alinity c analyzer. The semiquantitative application 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) are 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. Principle: competitive binding between drug-labeled G6PDH and sample drug for fixed antibody sites; free drug allows G6PDH to interact with substrate, increasing enzyme activity. Output: spectrophotometric measurement at 340 nm (NAD to NADH conversion) proportional to drug concentration. Used in clinical laboratories on Alinity c analyzer by trained professionals. Provides preliminary results; requires confirmation by LC-MS/MS or GC/MS. Assists clinicians in drug abuse screening and laboratory quality control.

Clinical Evidence

Bench testing only. Performance evaluated on Alinity c analyzer. Precision (n=120) showed clear separation at cutoffs. Method comparison against LC-MS/MS (n=100+ samples) demonstrated 100% agreement among positives and 96-98% agreement among negatives. Specificity and interference studies confirmed no significant cross-reactivity with structurally unrelated compounds or physiological substances.

Technological Characteristics

Homogeneous enzyme immunoassay. Reagents: mouse monoclonal anti-benzoylecgonine antibody, G6PDH-labeled benzoylecgonine analog, G6P, NAD, Tris/HEPES buffers, sodium azide preservative. Sensing: spectrophotometric (340 nm). Form: liquid ready-to-use. Connectivity: Alinity c analyzer system. Storage: 2–8 °C.

Indications for Use

Indicated for qualitative and/or semi-quantitative determination of benzoylecgonine (cocaine metabolite) in human urine at 150 ng/mL or 300 ng/mL cutoffs. For use by trained professionals in clinical laboratory settings. Not for distinguishing between abused drugs and 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).

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k211973

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.