(62 days)
Rapid Opiates Test Card II is an imunochromatorgraphy based one step in vitro test. It is designed for qualitative determination of Opiates and its metabolites in human urine specimens. The presence of Morphine in human urine above a cutoff level of 2,000ng/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.
The Rapid Drug tests are 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 antibody binding between drug conjugate and free drug which may be present in the urine specimen being tested.
When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody-dye conjugate. When the amount of drug is equal or more than the cutoff level, it will prevent the binding of drug conjugate to the antibody. As a result, 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.
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A table of acceptance criteria and the reported device performance
The provided text does not explicitly state formal acceptance criteria with specific numerical targets. However, the performance section indicates that the device's accuracy, precision, and other characteristics were evaluated, and the overall conclusion is that it is "substantially equivalent" to a legally marketed predicate device.
Performance Characteristic Evaluated Reported Device Performance (Implied Acceptance) Sensitivity Accuracy "comparison study of clinical urine specimens" showed the device to be "substantially equivalent to the Applied Biotech SureStep ™Drug Screen Test Morphine II." Stability - Specimen Evaluated (details not provided) Stability - Product Evaluated (details not provided) Precision Evaluated (details not provided) Reproducibility Evaluated (details not provided) Specificity Evaluated (details not provided) Interference Evaluated (details not provided) Overall Effectiveness "demonstrate Rapid Opiates Test Strip II and Rapid Test Card II to be substantially equivalent to the Applied Biotech SureStep ™Drug Screen Test Morphine II" -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text states: "Both urine control specimen and clinical urine specimen were tested to evaluate the safety and effectiveness of Rapid Opiates Test Strip II and Rapid Opiates Test Card II."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). It only mentions "clinical urine specimens."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the given text. The method for establishing ground truth is not detailed beyond the use of "urine control specimen and clinical urine specimen."
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the given text.
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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
No, an MRMC comparative effectiveness study involving human readers or AI assistance was not mentioned. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool for interpretation by human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance characteristics provided are for the device (Rapid Opiates Test Strip II and Rapid Test Card II) operating as a standalone diagnostic test, without human interpretation beyond reading the visual result. The "Indications for Use Statement" specifies it is "designed for qualitative determination... The test kit is used to obtain a visual, qualitative result and is intended for professional use."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The text mentions the use of "urine control specimen and clinical urine specimen." For drug tests, the ground truth is typically established through a reference method (e.g., Gas Chromatography-Mass Spectrometry (GC/MS) or other highly accurate laboratory methods) that quantifies the presence and concentration of the drug in the urine. While not explicitly stated as GC/MS, the "comparison study of clinical urine specimens" and the determination of "sensitivity accuracy" imply a highly reliable reference method was used to establish the true presence or absence of opiates.
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The sample size for the training set
This device is an immunochromatography-based test, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set size does not apply. The development would involve analytical verification and validation using various concentrations of analytes and interferents, not a data-driven training set like for AI.
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How the ground truth for the training set was established
As explained in point 8, this device does not utilize a training set in the AI/machine learning context. The "ground truth" for the development and analytical validation of such a test would be established through precisely prepared controls (known concentrations of opiates and other substances) and clinical samples verified by a gold-standard laboratory method.
§ 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).