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The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine. The cutoff concentrations are as follow:

The QuickTox™ Multiple Drug Dipcard is used to obtain visual, qualitative results for multiple drugs-of-abused in humane urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

The QuickTox™ Multiple Drug Dipcard is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine.

The provided document is a 510(k) clearance letter for the QuickTox™ Multiple Drug Dipcard. It describes the device's intended use and the cutoff concentrations for various drugs, but it does not contain a study or data proving the device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the document.
• Sample size used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method: Not provided.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not provided.
• Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable as this is a physical diagnostic device, not an AI algorithm.
• Type of ground truth used: Not provided.
• Sample size for the training set: Not applicable as this is a physical diagnostic device, not an AI algorithm.
• How the ground truth for the training set was established: Not applicable as this is a physical diagnostic device, not an AI algorithm.

What the document does provide:

The document primarily serves as an FDA clearance letter, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies:

• Trade/Device Name: QuickTox™ Multiple Drug Dipcard-COC/MOR/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA
• Regulation Number and Name: 21 CFR 862.3250, Cocaine and cocaine metabolite test system (and other product codes for the other drugs)
• Regulatory Class: Class II
• Indications For Use: An in vitro screen test that contains chromatographic immunoassays for the rapid detection of cocaine (benzoylecgonine), morphine, methamphetamine, THC, amphetamines, phencyclidine, benzodiazepine (oxazepam), barbiturate (secobarbital), methadone, nortriptyline and their metabolites in human urine.
• Cutoff Concentrations (which could be considered part of the "acceptance criteria" for qualitative detection thresholds):

• Intended Use Details: Used to obtain visual, qualitative results for multiple drugs-of-abuse in human urine. Intended for professional in vitro diagnostic use only, not for over-the-counter sale.

To obtain the detailed study information you requested (like sample sizes, ground truth establishment, performance metrics beyond cutoffs), one would typically need to review the original 510(k) submission summary or associated scientific literature, which is not provided in this document. The FDA clearance letter summarizes the regulatory decision, but not the underlying technical validation studies in detail.

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