(385 days)
The Rapid Reader System is designed to read , capture, document and archive ABMC's Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC test"). The Rapid Reader is used to obtain qualitative results (equivalent to manual read test results) and is intended for professional and point of care use only. It is not intended for over the counter sale to non-professionals. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gaschromatography/mass spectrometry (GC/MS).
The Rapid Reader System is a reader designed to capture, document and archive ABMC Drug of abuse test results using Rapid Drug Screen®, Rapid One®, and Rapid TEC® screening immunoassays ("ABMC tests"). The Rapid Reader is used to obtain qualitative results and is intended for professional use only. This Reader, combined with ABMC tests is a simplified qualitative screening method that provides a preliminary indication of drugs in urine. Results should be confirmed using appropriate confirmation methods. i.e., gas-chromatography/mass spectrometry (GC/MS).
The Rapid Reader utilizes a digital camera, pictures are analyzed using software algorithm developed to read any of American Bio Medica Corporation's (ABMC's) drugs of abuse screening immunoassays. These immunoassays include the Rapid Drug Screen®, Rapid One®, or Rapid TEC® drug of abuse test for the simultaneous detection of up to 10 drugs of abuse in human urine. All of these tests have been previously FDA cleared as Class II devices.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correctly identified drug-free specimens as negative (equivalent to manual interpretation). | The Rapid Reader interpretation and manual interpretation correctly identified 100% of drug-free specimens as negative. |
| Correctly identified specimens containing drug at a concentration above cutoff as positive (equivalent to manual interpretation). | The Rapid Reader interpretation and manual interpretation correctly identified 100% of specimens containing drug at a concentration above the cutoff level for each of the 14 drugs of abuse as positive. |
| Qualitative results equivalent to manual read test results. | The study implicitly demonstrates this by showing 100% concordance with manual interpretation for both negative and positive results across all tested drugs. The conclusion states: "The evaluation has led to the assurance that the performance of the Rapid Reader in correctly interpreting the ABMC test result is equivalent to the performance of reading the test manually." |
Study Details:
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Sample size used for the test set and the data provenance: Not explicitly stated. The text mentions "Certified negative and positive controls for each of the 14 drugs of abuse were tested," suggesting a set of controlled samples. The provenance (country of origin, retrospective/prospective) is not specified, but the study inherently appears prospective in nature as it describes an evaluation being conducted.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Three "untrained professionals" performed the manual interpretation which served as the reference for comparison. Their specific qualifications beyond "untrained professionals" are not provided.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated, but the process implies direct comparison of the Rapid Reader's output to the manual interpretation by the three "untrained professionals." It's not clear if there was a formal adjudication process if these three professionals disagreed amongst themselves.
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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, in the typical sense of measuring human reader improvement with AI assistance, was not performed. This study compared the device (Rapid Reader) against manual human interpretation, not human readers with and without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the described study is a standalone performance evaluation. The Rapid Reader generated results independently, which were then compared to human manual interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by "manual interpretation (human eye interpretation)" performed by three "untrained professionals," combined with the use of "certified negative and positive controls" for each drug. This is a form of expert consensus/reference standard.
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The sample size for the training set: Not provided. The document focuses exclusively on the performance evaluation of the Rapid Reader, not its development or training data.
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How the ground truth for the training set was established: Not provided.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).