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The Genie Cup™ Integrated Screening Device is a professional use, rapid, multiple immunoassay tool for the qualitative detection of the major metabolites of the following drugs of abuse in urine at the SAMHSA specified (except for methamphetamines) cutoff concentrations.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is a 510(k) clearance letter from the FDA for the "Genie Cup™ Integrated Screening Device."

While it mentions the intended use and cutoff concentrations for certain substances, it does not include:

• A table of acceptance criteria and reported device performance. It lists cutoff concentrations but not the performance metrics against those cutoffs (e.g., sensitivity, specificity).
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details about standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size and ground truth establishment for the training set.

The document primarily focuses on the FDA's determination of substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market the device. It refers to "established economics of the major metabolites of Sep" and SAMHSA specified cutoff concentrations, suggesting that the device's design aligns with existing standards, but it doesn't present the specific rigorous study data you're asking for.

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The FINGERPRINT Drug Screening Device™ is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the National Institute on Drug Abuse (NIDA) specified cutoff concentrations.

AMP amphetamines 1000 ng/ml
COC cocaine 300 ng/ml
MOR opiates 300 ng/ml
PCP phencyclidine 25 ng/ml
THC cannabinoids 50 ng/ml

FINGERPRINT Drug Screening Device™ test provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical test result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmed analytical result. 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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The provided text is a 510(k) clearance letter from the FDA for a device called "FINGERPRINT Drug Screening Device™". It describes the intended use and includes a table of drug analytes and their respective cutoff concentrations. However, it does not include specific information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample size, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory communication confirming substantial equivalence, not a scientific study report.

Ask a specific question about this device