(43 days)
Syntron's QuikPac II One Step Opiate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Opiate in urine at the cutoff level of 300 ng/ml. The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikPac II One Step Opiate Test is not intended to monitor drug levels, but only to screen urines for the presence of Opiate and its metabolites.
Syntron's QuikPac II One Step Opiate Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 300 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.
Here's an analysis of the provided text regarding the QuikPac II One Step Opiate Test, focusing on acceptance criteria and supporting study data:
Acceptance Criteria and Device Performance for QuikPac II One Step Opiate Test
The QuikPac II One Step Opiate Test is a rapid, qualitative, competitive binding immunoassay intended for the determination of Opiate in urine at a cutoff level of 300 ng/ml. The device's performance was evaluated through in-house testing and a clinical trial.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds (e.g., "Sensitivity must be >95%"). Instead, it presents the achieved performance. Based on the "Summary of Safety and Effectiveness," the implied acceptance criteria were likely perfect or near-perfect agreement with the predicate device (Emit II®) and confirmation by GC/MS.
| Performance Metric | Implied Acceptance Criteria (Based on reported results) | Reported Device Performance |
|---|---|---|
| In-House Testing | ||
| Relative Sensitivity | 1.000 (100%) | 1.000 (100%) |
| Relative Specificity | 1.000 (100%) | 1.000 (100%) |
| Accuracy | 100% | 100% |
| Clinical Trial | ||
| Relative Sensitivity | 100% | 100% |
| Relative Specificity | 100% | 100% |
| Accuracy | 100% | 100% |
| False Positives | Zero | Zero |
| False Negatives | Zero | Zero |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Trial): 298 samples.
- Data Provenance: The text refers to "in-house testing" and "a clinical trial" as well as an "independent clinical trial." It does not explicitly state the country of origin but given the submitting company (Syntron Bioresearch, Inc.) is in Carlsbad, California, and the FDA submission, it's highly likely the data is from within the United States. The studies appear to be retrospective, as samples were "documented to be positive by GC/MS" and then tested with the device and a predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth appears to be established by comparison to Syva EMIT® II and confirmed by GC/MS.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test (lateral flow immunoassay), not an image-based or interpretation-based diagnostic device that typically involves multiple human readers. The comparison was device-to-device (QuikPac II vs. Emit II®) with GC/MS confirmation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance presented is for the device operating in a standalone manner. While the test is read visually, the performance metrics (sensitivity, specificity, accuracy) relate to the device's ability to correctly identify the presence or absence of opiates in comparison to reference methods, without considering a human reader's interpretive variability as a primary outcome. The context implies a direct, objective readout based on the presence or absence of a color band.
7. The Type of Ground Truth Used
The ground truth used was a combination of:
- Comparison to a predicate device: Syva EMIT® II.
- Confirmatory method: Gas Chromatography/Mass Spectrometry (GC/MS) for all positive samples from either screening method. GC/MS is considered a "gold standard" for drug confirmation.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. The reported study appears to be the primary validation study, potentially serving as both internal evaluation and external validation.
9. How the Ground Truth for the Training Set Was Established
Since a separate training set is not explicitly mentioned or described, the method for establishing its ground truth is not provided. If the validation samples were also used for any iterative development, the ground truth would have been established as described in point 7.
§ 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).