(101 days)
dBest Amphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml. The dBest Amphetamines Test Kits are for professional and laboratory use only.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "dBest AMP Test Kit" and related documents. It does not contain the detailed information necessary to answer all the questions about acceptance criteria or a specific study proving the device meets them. This type of regulatory document typically confirms equivalence to a predicate device based on submitted data, rather than detailing the full study methodology and results.
However, based on the limited information present in the document, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a detailed performance table. The "Indications For Use" section provides a key performance characteristic:
| Characteristic | Acceptance Criterion (Implicit) | Reported Performance (Implicit) |
|---|---|---|
| Amphetamines detection cutoff in urine | N/A (Not explicitly stated as a criterion) | 1000 ng/ml |
2. Sample size used for the test set and the data provenance
This information is not available in the provided text. The document is a clearance letter, not the study report itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided text.
4. Adjudication method for the test set
This information is not available in the provided text.
5. 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
This device is an "immunochromatographic assay" – a rapid test kit for detecting amphetamines. It is not an AI-powered diagnostic device, nor does it involve "human readers" in the sense of interpreting complex images. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to AI algorithm performance. As established above, this is not an AI device. The device itself is standalone in that it provides a direct result (qualitative detection of amphetamines).
7. The type of ground truth used
While not explicitly stated for the testing proving the device performance, for a diagnostic test like this, the ground truth would typically be established by a reference method, such as:
- Mass Spectrometry (e.g., GC-MS or LC-MS): This is the gold standard for confirming drug presence and concentration in urine samples.
8. The sample size for the training set
This information is not available in the provided text, as it doesn't describe the study details. Furthermore, for a simple immunochromatographic assay, the concept of a "training set" (as typically used in machine learning) might not directly apply in the same way. Development would involve extensive analytical validation, but not necessarily machine learning training.
9. How the ground truth for the training set was established
This information is not available in the provided text. (See point 8 regarding "training set.")
§ 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).