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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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DRUG CHECK is a rapid immunochromatography assay designed for the simultaneous qualatative detection of cocaine, amphetamines, THC, morphine, PCP, and/or their metabolites in urine. It is an in vitro test intended for professional use.

The DRUG CHECK assay provides only a preliminary analytical test result. A more specific alterate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MC) is the preferred confirmatory method. (1) Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

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This document is a letter from the FDA regarding clearance for a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory clearance letter, not a scientific study report.

Therefore, I cannot extract the requested information from the provided text.

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The Texas FIRST SIGH test is a 3 minute one step pregnancy test for the dectection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use.

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The provided document is a 510(k) premarket notification letter for a device called "FIRST SIGN II." This letter approves the device for marketing and mentions its intended use. However, it does not contain a study report or detailed performance data to describe specific acceptance criteria and how a study proved the device meets them.

The document only states the "Indications For Use" for the FIRST SIGN test: "a 3 minute one step pregnancy test for the detection of human chorionic gonadotropin(hCG) in urine with a hCG Cut-off of 25 mIU/ml and is an aid in the early detection of pregnancy. This test is for over-the-counter and/or professional use."

Without a detailed study report, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. This type of information would typically be found in the 510(k) submission itself, which is not provided here.

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A rapid enzyme immunoasay test for the quantitative detection of cardiac troponin-I in serum and heparinized plaama as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use.

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The provided text is a 510(k) premarket notification approval letter for the "Tarqet Cardiac Troponin-I Test." Such letters primarily convey regulatory approval and substantial equivalence findings. They do not typically contain detailed descriptions of acceptance criteria, study designs, sample sizes, or ground truth establishment.

Therefore, the requested information regarding acceptance criteria, study specifics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in the provided document.

The document only states the device's indications for use: "A rapid enzyme immunoassay test for the quantitative detection of cardiac troponin-I in serum and heparinized plasma as an aid in the diagnosis of acute myocardial infarction. This test is to be used in clinical and hospital laboratories and is not for Doctor's offices use."

To obtain the requested information, one would need to consult the original 510(k) submission document (K972094) from Texas Immunology, Inc., which would have included the performance data and study details that the FDA reviewed to make its substantial equivalence determination.

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