(227 days)
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
DrugStop is the first step in a two step testing process. If a result is NEGATIVE, then, the person being tested probably does not have that drug in their body. HOWEVER, if the result is PRELIMINARY, the sample NUST be sent to our reference lab for confirmation at no additional cost to the customer. Home drug tests are not as accurate as lab tests and any PRELIMINARY results NUST BE CONFIRMED before any action is taken against the person being tested.
DrugStop is an at home drug screening test and if necessary a confirmation service. This product is a preliminary screen to detect and identify the presence of drugs within the body using a urine sample. The device is designed to detect the presence of COC (Cocain, Crack), THC (Marijuana, Pot, Cannabis), NOR (Opiates, Herion, Morphine), AMP (Amphetamine, Speed, Methamphetamine), PCPC (Angel Dust).
I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is an FDA 510(k) clearance letter for the "DrugStop" device, indicating that it has been found substantially equivalent to a legally marketed predicate device.
However, this document does not contain the detailed study results, acceptance criteria for performance, or information about the specific studies conducted to establish the device's performance. It is a regulatory clearance letter, not a scientific study report.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
- If a standalone (algorithm only) performance study was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The document only states the device's name, its intended use (at-home drug screening for COC, THC, NOR, AMP, PCPC, with confirmation service for preliminary positive results), and that it is considered substantially equivalent to a predicate device. It also explicitly mentions that "Home drug tests are not as accurate as lab tests and any PRELIMINARY results MUST BE CONFIRMED before any action is taken against the person being tested." This statement implies a known difference in accuracy compared to lab tests but does not quantify it or provide specific performance metrics.
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