(95 days)
An in vitro test for the qualitative identification of barbiturates in urine at a cutoff concentration of 200 ng/mL of Secobarbital. Measurements that are obtained by this device are used in the screening for drug abuse.
Immunoassay for the qualitative detection of barbiturates in urine. The QuickScreen™ Test, like many commercially available drug screening test kits, qualitatively measures the presence of barbiturates by visual, color sandwich, one-step immunoassay technology.
Acceptance Criteria and Study for QuickScreen™ Barbiturates Screening Test
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines the acceptance criteria as achieving "substantial equivalence to the reported performance characteristics of other commercially available tests for the qualitative detection of barbiturates in urine." The specific performance metric provided is agreement with a predicate device.
| Acceptance Criteria | Reported Device Performance (QuickScreen™ Barbiturates Screening Test) |
|---|---|
| Substantial equivalence to predicate devices (qualitative detection of barbiturates in urine) | 97% agreement when compared to the Behring EMIT II |
2. Sample Size and Data Provenance for Test Set:
- Clinical Sample Correlation Study: The exact sample size for this study is not explicitly stated. It refers to "clinical specimens" without specifying the number.
- Data Provenance: Retrospective, as it involved "clinical specimens" and "correlation studies," suggesting analysis of previously collected samples. The country of origin is not specified, but the manufacturer is based in San Diego, California, USA, implying U.S. data.
- Blind-Labeled Spiked Sample Study: The exact sample size for this study is not explicitly stated.
- Data Provenance: Prospective, as it involved "spiked samples," indicating controlled addition of the substance to samples for testing. The country of origin is not specified, but the manufacturer is based in San Diego, California, USA, implying U.S. data.
3. Number and Qualifications of Experts for Ground Truth:
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set.
4. Adjudication Method for the Test Set:
The adjudication method is not mentioned. The primary comparison is against a "predicate device" (Behring EMIT II) for the clinical samples and through "blind-labeled spiked samples."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focuses on the device's performance against a predicate device and spiked samples, not on human reader improvement with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The "clinical sample correlation study and a blind-labeled spiked sample study" evaluate the QuickScreen™ Barbiturates Screening Test's performance independently, comparing its results to a ground truth (either the predicate device's results or the known concentrations in spiked samples).
7. Type of Ground Truth Used:
- Clinical Sample Correlation Study: The ground truth was established by another "commercially available test" – the Behring EMIT II. This is a form of comparative ground truth against an established method.
- Blind-Labeled Spiked Sample Study: The ground truth was based on known concentrations of barbiturates in the "spiked samples." This represents a form of analytical ground truth.
8. Sample Size for the Training Set:
The document does not provide information about a separate training set or its sample size. The studies described appear to be validation or performance evaluation studies, not explicitly detailing a training phase for a learning algorithm.
9. How Ground Truth for Training Set Was Established:
As no training set is explicitly mentioned, the method for establishing its ground truth is not provided. The device described uses "basic immunochemical sandwich assay principle," which is a traditional laboratory method and does not typically involve machine learning requiring a "training set" in the modern sense.
§ 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).