(298 days)
The ForSure One Step Buprenorphine Drug Cup Test Device is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at cutoff level of 10 ng/mL. The test is intended for prescription and overthe-counter use.
The buprenorphine assay will yield preliminary positive results when buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The ForSure One Step Buprenorphine Drug Cup Test Device shows the drug was or was not present at the cutoff level. The assay provides only a preliminary analytical test result.
A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
ForSure" One Step Buprenorphine Drug Cup Test Device is a convenient specimen collection cup with a built-in strip holder which is able to hold the QuikStrip of Buprenorphine within the container. The membrane of the test strip is coated with goat anti-mouse antibody and Buprenorphine-Bovine serum albumin conjugate. The sample pad contains a colloidal gold-labeled mouse monoclonal anti-Buprenorphine antibody. As the test sample flows through the absorbent device, the Colloidal Gold labeled antibody-conjugate binds to the free drug in the specimen forming an antibody-conjugate in the test reaction zone and will not produce a magenta color band when the drug is above the detection level of 10 ng/ml 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 produces only one color band in the control area. There is no meaning attributed to color or its intensity for either line. The test is easy and fast allowing the user to visually read the screen for abuse of drugs without the need for any other instrumentation to determine results. The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine. If the Buprenorphine result shows 1 line (preliminary positive) you should send the sample for laboratory testing.
The provided document describes the ForSure™ One Step Buprenorphine Drug Cup Test Device (K122064). This summary focuses on the acceptance criteria and study information as requested.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity | Acceptance: ≥10ng/ml Buprenorphine in urine show positive result (Implied from predicate and subject device consistency) |
| Total Precision | Acceptance: No appreciable within and inter-lot variation for positive and negative spiked samples across three (3) different lots at different days (Implied from predicate and subject device consistency) |
| Cutoff Determination | Acceptance: Cutoff at 10 ng/ml. 50% below cutoff are negative. Cutoff and 25% above cutoff are positive. (Implied from predicate and subject device consistency) |
| Accuracy | Acceptance: Comparison study of positive and negative specimens with GC/MS shows very good correlation. (Implied from predicate and subject device consistency) |
| Assay Time | Acceptance: 5 minutes (Explicitly stated in comparison table) |
| Matrix | Acceptance: Urine (Explicitly stated in comparison table) |
| Preliminary Positive Reconfirmation | Acceptance: Yes, by GC/Mass (Explicitly stated in comparison table) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "A comparison study of positive and negative specimens with GC/MS was performed" for accuracy, without providing specific numbers of specimens.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the number of experts used or their qualifications for establishing ground truth. The ground truth method used (GC/MS) is an objective analytical method, not dependent on expert interpretation in the same way as, for example, image review by radiologists.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a definitive analytical method and does not typically involve adjudication among human experts for preliminary results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a "visual read single use" diagnostic, where results are read directly, not through interpretation by multiple human readers that would then be compared to AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a standalone diagnostic tool, as it is a "visual read single use" lateral flow immunoassay. The intended use description explicitly states, "The tester will obtain a result in five minutes. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. This test is the first step in determining whether there are drugs in the urine." This indicates its standalone performance provides a preliminary result, with confirmatory testing (GC/MS or LC/MS) recommended for positive findings. The performance metrics (Sensitivity, Precision, Cutoff, Accuracy) are related to this standalone analytical performance.
7. Type of Ground Truth Used
The ground truth used for the accuracy study was Gas Chromatography/Mass Spectrometry (GC/MS). The text states: "A comparison study of positive and negative specimens with GC/MS was performed." It also mentions Liquid Chromatography/Mass Spectrometry (LC/MS) as another preferred confirmatory method.
8. Sample Size for the Training Set
The document does not provide information on a "training set" sample size. This device is a lateral flow immunoassay, which is a chemical and biological test, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its development would involve chemical and biological optimization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of an AI/machine learning algorithm, this question is not applicable. The development of this immunochromatographic assay relies on established biochemical principles and would involve iterative testing against known concentrations of Buprenorphine and its metabolites, similar to how the performance metrics (sensitivity, cutoff, accuracy) are assessed.
§ 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).