(34 days)
Syntron's QuikPac II One Step Barbiturate assay is a rapid, qualitative, competitive binding immunoassay for the determination of Barbiturate in urine at the cutoff level of 200 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 indicated. Syntron's QuikPac II One Step Barbiturate Test is not intended to monitor drug levels, but only to screen urines for the presence of Barbiturate and its metabolites,
Syntron's QuikPac II One Step Barbiturate 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 200 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 a breakdown of the acceptance criteria and study details for the QuikPac II One Step Barbiturate Test:
1. Acceptance Criteria and Reported Device Performance:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Clinical Trial) |
|---|---|---|
| Relative Sensitivity | High (Close to 100%) | 100% |
| Relative Specificity | High (Close to 100%) | 99.41% |
| Accuracy | High (Close to 100%) | 99.61% |
The document states "By non parametric testing the results are not significantly different from one another," suggesting that the performance against the predicate device (Emit II®) was considered acceptable.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 307 samples
- Data Provenance: Not explicitly stated, but implies a clinical trial setting. The document mentions "A clinical trial consisting of 307 samples was run," suggesting prospective data collection. The country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not explicitly stated how many experts were involved. The ground truth was established by instrumental analysis (GC/MS).
- Qualifications: Not applicable for establishing ground truth as it was based on GC/MS.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated as a formal adjudication process. The primary comparator was Syva EMIT® (200) II, with all positive samples by either screening method (QuikPac II or EMIT II®) then confirmed by GC/MS (200 ng/ml). This acts as a confirmatory "adjudication" for positive results.
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 performed. This device is a qualitative diagnostic test that provides a visual readout (color band), not an imaging-based interpretation requiring multiple human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this study is inherently a standalone performance evaluation of the device. The QuikPac II test is designed to provide a direct readout without human interpretation beyond observing the presence or absence of a color band, and then comparing that result to other methods. The performance metrics (sensitivity, specificity, accuracy) are for the device itself.
7. The Type of Ground Truth Used:
- Type of Ground Truth: Gold standard instrumental analysis: Gas Chromatography/Mass Spectrophotometry (GC/MS) at a cutoff of 200 ng/ml.
8. The Sample Size for the Training Set:
- The document does not explicitly mention a separate "training set" or its size. In-house testing was performed, but the number of samples in this phase is not specified. For this type of diagnostic device, development often involves internal validation rather than distinct "training" and "test" sets in the machine learning sense. The 307 samples represent the clinical trial/test set.
9. How the Ground Truth for the Training Set Was Established:
- As a distinct training set is not explicitly mentioned, the method for establishing ground truth for any in-house testing (development/validation) would likely be similar to the clinical trial: comparison against a reference method (Syva EMIT®) and confirmation of true positives by GC/MS.
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).