FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).