(143 days)
Rapid Barbiturate Test Strip is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
Rapid Barbiturate Test Card is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Barbiturate and its metabolites in human urine specimens. The presence of secobarbital in human urine above a cutoff level of 300ng/ml can be detected. The test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale to lay persons. This test provides only a preliminary analytical test result. A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result.
The RapidBAR test is based on the principle of specific immunochemical reaction between antibodies and antigens to analyze particular compounds in human urine specimen. The assay relies on the competition for binding anti-barbiturate antibody between barbiturate-protein conjugate and free drug which may be present in the urine specimen being tested. When barbiturate is present in the urine specimen, it competes with barbiturate-protein conjugate for the limited amount of mouse anti-barbiturate MAb-colloidal gold conjugate. When the amount of barbiturate is equal or more than the cut-off, it will prevent the binding of barbiturateprotein conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line composed of Goat anti-Mouse IgG antibody is present in the test window to work as procedural control. This colored band should always appear on the control line zone if the test device is stored in good condition and the test is performed appropriately.
The provided document describes the 510(k) summary for the Rapid Barbiturate Test Strip and Rapid Barbiturate Test Card. It states the intended use as qualitative determination of secobarbital in human urine specimens above a cutoff level of 300 ng/ml. The document focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and performance data in a comprehensive study report.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity thresholds). Instead, it lists various "Performance" studies conducted, implying that these studies were performed to demonstrate the device's acceptable performance and substantial equivalence.
| Performance Study | Reported Device Performance |
|---|---|
| Rapid Barbiturate Test Strip Sensitivity | Implied as acceptable for substantial equivalence, but no specific values provided. |
| Rapid Barbiturate Test Strip Accuracy (comparison study of clinical urine specimens) | Implied as acceptable for substantial equivalence, but no specific values provided. |
| Stability - Specimen Stability | Study performed, but no specific results or acceptance criteria given. |
| Stability - Product | Study performed, but no specific results or acceptance criteria given. |
| Precision | Study performed, but no specific results or acceptance criteria given. |
| Reproducibility | Study performed, but no specific results or acceptance criteria given. |
| Specificity | Study performed, but no specific results or acceptance criteria given. |
| Interference | Study performed, but no specific results or acceptance criteria given. |
| Rapid Barbiturate Test Card Accuracy (comparison study of clinical urine specimens) | Implied as acceptable for substantial equivalence, but no specific values provided. |
| Precision | Study performed, but no specific results or acceptance criteria given. |
| Comparison between Rapid Barbiturate Test Strip and Test Card | Study performed, but no specific results or acceptance criteria given. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that "Both urine control specimen and clinical urine specimen were tested," but it does not provide the specific sample size for either the control or clinical urine specimens used in the accuracy/comparison studies.
- Data Provenance: The country of origin of the data is not explicitly stated. Given the manufacturer's address in Burlingame, CA, U.S.A., and the FDA 510(k) submission, it is implied that the studies were conducted to meet U.S. regulatory standards, but the physical location of the data collection is not specified. The studies involved "clinical urine specimens," indicating they were likely retrospective or prospective collections from a clinical setting, but this detail is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in-vitro diagnostic devices like this, ground truth for drug testing typically involves confirmatory methods.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this type of device. The Rapid Barbiturate Test is a rapid immunochromatography test designed for a qualitative, visual result, primarily relying on the presence or absence of a colored band. It does not involve human readers interpreting complex images or data in a way that an MRMC study would assess. The "comparison study of clinical urine specimens" mentioned is a comparison of the device's results against a reference method (ground truth), not a comparison of human reader performance with and without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study was done for both the Rapid Barbiturate Test Strip and Test Card. The document lists "Sensitivity Accuracy (comparison study of clinical urine specimens)," "Precision," "Reproducibility," "Specificity," and "Interference" as studies performed. These studies evaluate the device's intrinsic performance characteristics.
7. Type of Ground Truth Used
The most common type of ground truth for urine drug screens is a more specific and sensitive chemical method, such as Gas Chromatography-Mass Spectrometry (GC/MS). While the document states, "A more specific chemical method, such as GC/MS, must be used in order to obtain a confirmed analytical result," it doesn't explicitly state that GC/MS was used as the ground truth for the comparison studies mentioned. However, this is the standard practice for validating such devices, and it is highly probable that a similar confirmatory method was employed for ground truth establishment.
8. Sample Size for the Training Set
This information is not provided in the document. Immunochromatographic assays like this are typically developed based on laboratory experiments and antibody-antigen binding characteristics, rather than "training" an algorithm on a large dataset in the way a machine learning model would be. Therefore, the concept of a "training set" in the context of an algorithm may not directly apply.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for this type of device is not directly applicable in the same way it would be for AI/ML algorithms. The ground truth for the underlying immunochemistry would be established through known concentrations of barbiturates and cross-reactants, and the selection of antibodies would be based on their empirically determined binding characteristics. The document does not provide details on this developmental process.
§ 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).