(195 days)
For Sure One Step Buprenorphine Test Card is an immunochromatographic enzyme immunoassay for qualitative determination of the presence of buprenorphine in human urine at cutoff concentration of 10 ng/ml. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
For Sure Buprenorphine Rapid Test Card consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate in whilel the arag of aring membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibodysample from and ages free drug in the specimen forming an antibody-antigen complex. conjugate onlike to the from bilized antigen conjugate in the Test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 will of Buprenorphine. Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. A NEGATIVE specimen produces two distinct color bands in both the test line and control area. A POSITIVE specimen unor color band in the control area. There is no meaning attributed to color produces only one other line. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's a breakdown of the acceptance criteria and study information for the "For Sure Buprenorphine Rapid Test Card" based on the provided text:
Important Note: The provided document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain a detailed study report with all the specific performance metrics and methodologies that would typically be found in a full scientific publication or comprehensive regulatory submission. Therefore, some requested information (like specific sample sizes for test and training sets, number and qualifications of experts, and MRMC study details) is not explicitly stated in this document.
Acceptance Criteria and Reported Device Performance
The document implies acceptance criteria based on the comparison to the predicate device and the intended use. The primary performance metric mentioned is the device's ability to qualitatively determine the presence of buprenorphine at a specific cutoff concentration.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative Detection of Buprenorphine at 10 ng/ml Cutoff | The device provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine at a cutoff concentration of 10 ng/ml. |
| Consistency with Intended Use | The device's intended use is for immunochromatographic enzyme immunoassay for qualitative determination of buprenorphine in human urine. |
| Substantial Equivalence to Predicate Devices | Demonstrated through comparison of intended use, analytical properties (analyte, cutoff, matrix), and operational characteristics (instrument, calibration, storage) to CEDIA Buprenorphine ASSAY (K040316) and GC/MS. |
| Demonstrates Reagent and Device Functioning (Control Zone) | Unbound colloidal gold-labeled antibody conjugate binds to the reagent in the negative control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. |
| Absence of False Negatives (above cutoff) | The drug or drug metabolites in the sample compete with a drug conjugate. If the drug is above the detection level of 10 ng/ml of Buprenorphine, it will not produce a magenta color band in the test reaction zone. |
| Absence of False Positives (below cutoff) | A NEGATIVE specimen produces two distinct color bands in both the test line and control area. (Implies no test line appears if below cutoff.) |
Study Details
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Sample sizes used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated in the provided text.
- Data Provenance: Not explicitly stated. The submission is from Tianjin New Bay Bioresearch Co., Ltd. in China, but the origin of the urine samples used for testing is not detailed. It is also not specified if the data was retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated. However, the preferred confirmatory method for ground truth is Gas Chromatography/Mass Spectrometry (GC/MS), which would typically be performed and interpreted by qualified laboratory personnel (e.g., toxicologists, chemists).
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Adjudication method for the test set:
- Adjudication Method: Not explicitly stated. The document refers to GC/MS as the preferred confirmatory method, implying this is the gold standard for ground truth, rather than an adjudication among human readers for the device itself.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is a rapid, visual immunoassay test card, not an AI-powered diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Yes, in the sense that the test card itself provides a visual result (presence or absence of a line) without needing a human to interpret complex data from an algorithm. The reading is visual: "A NEGATIVE specimen produces two distinct color bands... A POSITIVE specimen produces only one color band in the control area." This is the "algorithm only" performance for this type of device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Gas chromatography /mass spectrometry (GC/MS) is explicitly stated as the preferred confirmatory method for obtaining confirmed analytical results. This serves as the gold standard ground truth.
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The sample size for the training set:
- Sample Size (Training Set): Not explicitly stated. This document primarily focuses on the substantial equivalence study for regulatory clearance, not the development process of the immunoassay itself.
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How the ground truth for the training set was established:
- Ground Truth (Training Set): Not explicitly stated. Again, the document focuses on regulatory clearance. However, it's highly probable that similar laboratory methods, likely GC/MS, would have been used during the development and optimization (training) phase of the immunoassay to establish its performance characteristics against known samples.
§ 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).