IMMULITE COCAINE METABOLITE

K963918 · Diagnostic Products Corp. · DIO · Apr 8, 1997 · Clinical Toxicology

Device Facts

• Record ID: K963918
• Device Name: IMMULITE COCAINE METABOLITE
• Applicant: Diagnostic Products Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Apr 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE® Automated Analyzer for the semi-quantitative measurement of benzoylecgonine and its parent compound, cocaine, in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for cocaine and its principal metabolites.

Device Story

IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent enzyme immunoassay for urine analysis. It utilizes an IMMULITE® Automated Analyzer to measure benzoylecgonine and cocaine concentrations. The process involves a polystyrene bead coated with monoclonal antibodies; patient sample and alkaline phosphatase-conjugated benzoylecgonine are incubated; competitive binding occurs; centrifugal wash removes unbound conjugate; chemiluminescent substrate (PPD) is added. Alkaline phosphatase hydrolyzes PPD, producing light emission inversely proportional to analyte concentration. The system is used in clinical laboratories; results are interpreted by healthcare providers against a 300 ng/mL cutoff to identify potential cocaine use, necessitating confirmatory testing (e.g., GC/MS). The device provides automated, rapid semi-quantitative results, assisting in clinical decision-making regarding drug use or overdose.

Clinical Evidence

No clinical studies performed. Performance established via method comparison of 351 urine samples against the predicate (Coat-A-Count). Results showed 229 positive/106 negative agreement. 223 IMMULITE-positive samples were further validated against GC/MS (150 ng/mL cutoff), achieving a 99% (221/223) confirmation rate.

Technological Characteristics

Solid-phase chemiluminescent immunometric assay. Components: polystyrene bead coated with monoclonal anti-benzoylecgonine antibody, alkaline phosphatase-conjugated benzoylecgonine, and PPD (phosphate ester of adamantyl dioxetane) substrate. Operates on the IMMULITE® Automated Analyzer. Measurement principle: competitive binding with light emission inversely proportional to analyte concentration. No specific ASTM standards cited.

Indications for Use

Indicated for the semi-quantitative measurement of benzoylecgonine and cocaine in urine to aid in the diagnosis and treatment of cocaine use or overdose. Intended for use in programs requiring confirmatory testing.

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).

Predicate Devices

• DPC's Coat-A-Count (CAC) Cocaine Metabolite (K870740)

Submission Summary (Full Text)

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Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
Tel: [phone]
Fax: [phone]
1<903918
APR - 8 1997

# 510 (k) Summary of Safety and Effectiveness

*This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.*

**Name:** Diagnostic Products Corporation (DPC)
**Address:** 5700 West 96th Street
Los Angeles, CA 90045-5597
**Telephone Number:** [phone]
**Facsimile Number:** [phone]
**Contact Person:** Edward M. Levine, Ph.D.
Director of Clinical Affairs
**Date of Preparation:** September 27, 1996
**Device Name:**
**Trade:** IMMULITE® Cocaine Metabolite
**Catalog Number:** LKCN1 (100 tests), LKCN5 (500 tests)
**Common:** Reagent system designed for the semi-quantitative analysis of benzoylecgonine, and its parent compound, cocaine, in urine.
**CFR:** 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.
**Classification:** Class II device (862.3250), 91-DIO
**Manufacturer:** Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, CA 90045-5597
**Establishment Registration #:** 2017183
**Substantially Equivalent**
**Predicate Device:** DPC's Coat-A-Count (CAC) Cocaine Metabolite (K870740)

## Description and Intended Use of Device:

IMMULITE® Cocaine Metabolite is a solid-phase, chemiluminescent enzyme immunoassay designed for use with the IMMULITE® Automated Analyzer for the semi-quantitative measurement of benzoylecgonine and its parent compound, cocaine, in urine. It is intended strictly for *in vitro* diagnostic use in the context of a program involving an established confirmatory test for cocaine and its principal metabolites.

## Substantial Equivalence Claim:

Diagnostic Products Corporation (DPC) asserts that DPC's IMMULITE® Cocaine Metabolite is substantially equivalent to DPC's Coat-A-Count (CAC) Cocaine Metabolite.


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Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
Tel: [phone]
Fax: [phone]

# DPC

## Intended Use Equivalence:

Each product is designed for the semi-quantitative measurement of cocaine metabolites in urine. Each product is intended strictly for *in vitro* diagnostic use, and each product provides a preliminary analytical test result.

## Performance Equivalence - Technological Comparison:

**IMMULITE® Cocaine Metabolite** is a chemiluminescent immunoassay. The technology in IMMULITE® Cocaine Metabolite is identical to technology used in previously cleared and commercially marketed IMMULITE® products. DPC's Coat-A-Count Cocaine Metabolite is a solid-phase $^{125}$I radioimmunoassay.

**IMMULITE® Cocaine Metabolite** is a solid-phase, chemiluminescent immunometric assay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a monoclonal antibody specific for benzoylecgonine. The patient sample and alkaline phosphatase-conjugated benzoylecgonine are simultaneously introduced into the Test Unit, and incubated for 30 minutes at $37^{\circ}\mathrm{C}$ with intermittent agitation. During this time, benzoylecgonine in the sample competes with the enzyme-labeled benzoylecgonine for a limited number of antibody binding sites on the bead. Unbound enzyme conjugate is then removed by a centrifugal wash, after which substrate is added and the Test Unit is incubated for a further 10 minutes.


The chemiluminescent substrate, PPD (a phosphate ester of adamantyl dioxetane), undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in a sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output as measured by the luminometer - is inversely proportional to the concentration of benzoylecgonine in the sample.

**DPC's Coat-A-Count® Cocaine Metabolite** is a solid-phase radioimmunoassay wherein $^{125}$I-labeled benzoylecgonine competes for a fixed time with benzoylecgonine in the patient sample for sites on benzoylecgonine-specific antibody. The antibody being immobilized to the wall of a polypropylene tube, decanting the supernatant suffices to terminate the competition and to isolate the antibody-bound fraction of the radiolabeled benzoylecgonine. Counting the tube in a gamma counter than yields a number, which converts by way of a calibration curve to a measure of the benzoylecgonine present in the patient sample.

## Performance Equivalence - Method Comparison:

**IMMULITE® Cocaine Metabolite** procedure was compared to Coat-A-Count Cocaine Metabolite on a total of 351 urine samples obtained from a drug testing laboratory, with the following results:

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Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
Tel: [phone]
Fax: [phone]

# Performance Equivalence - Method Comparison (continued):

DPC

| CAC | Positive | Negative |
| --- | --- | --- |
| Positive | 229 | 11 |
| Negative | 5 | 106 |

223 of the 234 specimens tested positive by the IMMULITE Cocaine Metabolite procedure were tested by the GC/MS procedure. 221 of the 223 IMMULITE positive specimens were found positive by the GC/MS procedure (cutoff 150 ng/mL), achieving a confirmation rate of 99% (221/223).

## Interpretation of Results

Using a cutoff of 300 ng/mL (0.3 ug/mL), as recommended in the SAMHSA guidelines, a numerical result greater than or equal to 300 ng/mL is interpreted as positive for cocaine metabolite, whereas a result less than 300 ng/mL is interpreted as negative.


## Clinical Studies:

Not applicable

## Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the device is safe, effective, and performs as well as or better than the legally marketed device.


EML/mb
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