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 Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the IMMULITE® Cocaine Metabolite device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets (e.g., sensitivity > 95%). Instead, it establishes "Performance Equivalence" to a predicate device. The performance is assessed by comparing the new device (IMMULITE® Cocaine Metabolite) against the predicate device (DPC's Coat-A-Count Cocaine Metabolite) and then further verifying positive results with a confirmatory method (GC/MS).

Acceptance Criteria (Implied)	Reported Device Performance
Substantially Equivalent to Predicate Device (DPC's Coat-A-Count Cocaine Metabolite)	Method Comparison against Predicate: - Agreement between IMMULITE® and Coat-A-Count (CAC) on 351 urine samples is shown in the contingency table (details below). - 229 samples positive by both, 106 negative by both. - 11 positive by IMMULITE® but negative by CAC. - 5 positive by CAC but negative by IMMULITE®.
Confirmation of Positive Results	GC/MS Confirmation of IMMULITE® Positives: - 221 out of 223 IMMULITE® positive specimens confirmed positive by GC/MS (cutoff 150 ng/mL). - Confirmation rate: 99% (221/223).
Safe and Effective	Concluded that the device is safe, effective, and performs as well as or better than the legally marketed device based on nonclinical tests.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (for Method Comparison): 351 urine samples.
Data Provenance: Obtained from a drug testing laboratory. No specific country of origin is mentioned, but "Los Angeles, CA" is the manufacturer's location, suggesting US origin. The samples are retrospective, as they were "obtained from a drug testing laboratory," indicating pre-existing samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The primary "ground truth" for the method comparison appears to be the predicate device (DPC's Coat-A-Count Cocaine Metabolite). For the confirmation of positive results, the ground truth was GC/MS (Gas Chromatography/Mass Spectrometry).
The document does not specify the number of experts or their qualifications who established the GC/MS results or who interpreted the results from the drug testing laboratory. GC/MS is an objective analytical method, so expert interpretation in the human sense is less relevant than proper laboratory protocols and calibration.

4. Adjudication Method for the Test Set

There is no explicit adjudication method described for the method comparison or for the GC/MS confirmation. The results are presented as direct comparisons to the predicate device and then to GC/MS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This device is a semi-quantitative immunoassay for measuring a chemical compound in urine, not an imaging device requiring human reader interpretation or AI assistance in the current sense. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance assessment was effectively done. The IMMULITE® Cocaine Metabolite system is an automated analyzer that provides a numerical result based on a chemiluminescent immunoassay. Its performance characteristics (comparison to a predicate and GC/MS) are assessed directly without human interpretation influencing the primary result generation. The "interpretation of results" using a 300 ng/mL cutoff is a predefined rule applied to the device's output, not human-in-the-loop performance.

7. The Type of Ground Truth Used

For Method Comparison: The ground truth was the predicate device (DPC's Coat-A-Count Cocaine Metabolite).
For Confirmation of Positive Results: The ground truth was GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug confirmation.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This is typical for an immunoassay where the underlying chemical and immunological principles are well-established, and the system is calibrated using known standards rather than being "trained" on a large dataset of patient samples in the way a machine learning algorithm would be.

9. How the Ground Truth for the Training Set Was Established

As no training set is described in the context of a machine learning model, the concept of establishing ground truth for it is not applicable here. The device's calibration would rely on reference standards of known benzoylecgonine concentrations.

Summary

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Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: (213) 776-0180 Fax: (213) 776-0204

K963918

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 StreetLos Angeles. CA 90045-5597
Telephone Number:	(213) 776-0180
Facsimile Number:	(213) 776-0204
Contact Person:	Edward M. Levine, Ph.D.Director of Clinical Affairs
Date of Preparation:	September 27. 1996
Trade:	IMMULITE® Cocaine Metabolite
Catalog Number:	LKCN1 (100 tests), LKCN5 (500 tests)
Common:	Reagent system designed for the semi-quantitativeanalysis of benzoylecgonine, and its parentcompound, cocaine, in urine.
CFR:	A device intended to measure cocaine and a cocainemetabolite (benzoylecgonine) in serum, plasma, andurine. Measurements obtained by this device areused in the diagnosis and treatment of cocaine use oroverdose.
Classification:	Class II device (862.3250), 91-DIO
Manufacturer:	Diagnostic Products Corporation (DPC)5700 West 96th StreetLos Angeles, CA 90045-5597
Establishment Registration #:	2017183
Substantially EquivalentPredicate Device:	DPC's Coat-A-Count (CAC) Cocaine Metabolite(K870740)

Description and Intended Use of Device:

Substantial Equivalence Claim:

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

Image /page/0/Picture/10 description: The image shows a logo with a globe in the background. In front of the globe, the number 25 is prominently displayed, signifying an anniversary. Below the number, the word "YEARS" is written. The phrase "EXCELLENCE IN DIAGNOSTICS" is written around the globe.

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Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: Fax: (213) 776-0204

Intended Use Equivalence:

Image /page/1/Picture/2 description: The image shows the logo for DPC. The letters are in a bold, sans-serif font and are all capitalized. The letters are black and the background is white. There is a registered trademark symbol in the upper right corner of the logo.

Each product is designed for the semi-quantitative measurement of cocaine metabolites in Each product is intended strictly for in vitro diagnostic use, and each product urine. 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℃ 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.

Image /page/1/Picture/7 description: The image shows a logo with the text "EXCELLENCE in DIAGNOSTICS" arranged in an arc at the top right. A globe is in the background, and the number "25" is prominently displayed in the foreground. The word "YEARS" is at the bottom of the logo.

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 1271-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: (213) 776-0180 Fax: (213) 776-0204

Performance Equivalence - Method Comparison (continued):

	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.

Image /page/2/Picture/6 description: The image shows a logo with the text "EXCELLENCE in DIAGNOSTICS" arranged in a circular fashion around a globe. The number "29" is prominently displayed on the left side of the globe, with the word "YEARS" written below it. The logo appears to be for a company or organization that has been in the diagnostics field for 29 years.

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.

Edward Hevia

9/16/56

Edward M. Levine, Ph.D. Director of Clinical Affairs

Date

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

(a)
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.(b)
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).