(266 days)
IMMULITE® Opiates Screen is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer and is designed for use as a semi-quantitative screen for opiates and metabolites in urine. It is intended strictly for in vitro diagnostic use in the context of a program involving an established confirmatory test for opiates.
IMMULITE® Opiates Screen is a solid-phase, chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Analyzer.
Here's a breakdown of the acceptance criteria and study details for the IMMULITE® Opiates Screen, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific numerical acceptance criteria for sensitivity, specificity, or agreement. Instead, it frames the study as a "Method Comparison" against commercially available immunoassays and GC/MS, aiming to demonstrate substantial equivalence and comparable performance. The reported performance is presented as a comparison to these existing methods.
However, based on the context of demonstrating "effective" and performing "as well as or better than the legally marketed device," we can infer that the device aimed for high agreement, sensitivity, and specificity. I'll present the reported performance against the predicate and other methods as the de facto "met criteria" for this submission.
| Metric | Against Roche Abuscreen OnLine (Comparator Immunoassay) | Against Syva Emit (Predicate Immunoassay) | Against GC/MS (Reference Method) |
|---|---|---|---|
| Agreement | 97.6% | 98.4% | 96.8% |
| Relative Sensitivity | 96.0% (92.8% - 98.1% CI) | 97.6% (94.8% - 99.1% CI) | 97.9% (95.1% - 99.3% CI) |
| Relative Specificity | 98.6% (96.9% - 99.6% CI) | 98.9% (97.3% - 99.7% CI) | 96.1% (93.6% - 97.8% CI) |
Note: The confidence intervals (CI) are for the respective sensitivity and specificity values.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 618 urine samples were used for the method comparison study.
- Data Provenance: The urine samples were "Randomly selected drug-free and drug-containing urine samples obtained from the Uddevalla Hospital in Uddevalla Sjukhus, Switzerland and tested on site." The study is retrospective as samples were "obtained" and then tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on the number of experts or their qualifications for establishing the ground truth.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. It primarily compares the IMMULITE® Opiates Screen against other assays and GC/MS. Discrepancies are noted (e.g., "8 of the 10 'false negative' cases were negative by GC/MS"), but an explicit adjudication process involving human reviewers is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of a diagnostic assay (IMMULITE® Opiates Screen) against other assays and a reference method, not on the impact of this assay on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The study is essentially a standalone (algorithm only) performance study in the context of the device's function. The IMMULITE® Opiates Screen is an automated immunoassay designed to provide a semi-quantitative result; its performance is measured directly, independent of human interpretation beyond the initial sample collection and result reporting. The comparison is between the device's output and the output of other devices/methods.
7. The Type of Ground Truth Used
The primary ground truth/reference method used for the most definitive comparison was GC/MS (Gas Chromatography/Mass Spectrometry). This is generally considered a highly accurate confirmatory method for drug testing. The document also used the results from two other commercially available immunoassays (Roche Abuscreen OnLine and Syva Emit) as comparators.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is typical for a diagnostic assay like this, where the "training" (if any, e.g., for calibrating the assay) is internal to the manufacturer's development and not usually part of the external validation study reported for submission. The provided study describes a validation/test set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, information on how its ground truth was established is not provided.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).