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This homogeneous tricyclics serum tox enzyme immunoassay is intended to be used for qualitative and semiquantitative determination of tricyclic antidepressants in serum, plasma or urine of patients suspected of drug overdose. A 300 ng/mL nortriptyline cutoff calibrator is used in this assay to differentiate a positive from a negative sample. Detection of the drug presence and its approximate concentration in serum, plasma or urine from patients suspected of drug overdose can assist the physician in diagnosis and determination of steps towards treatment.

homogeneous tricyclics serum tox enzyme immunoassay

This document is a 510(k) clearance letter from the FDA for a medical device called the "Tricyclic Serum Tox EIA Assay." This letter grants permission to market the device, indicating that it has been found substantially equivalent to a predicate device.

Unfortunately, the provided document {0}, {1}, and {2} does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on the regulatory clearance process and states the intended use of the device. It does not include a performance study report or any data related to method validation or clinical trials that would detail acceptance criteria and a study proving the device meets them.

Therefore, I cannot provide the requested information based on the provided text. To answer these questions, a separate document detailing the device's performance study, such as a summary of safety and effectiveness, would be needed.

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The N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma. NAPA is the major metabolite of procainamide. Its pharmacologic activity is almost equal to that of procainamide. Furthermore, serum NAPA concentration may exceed its parent drug concentration. Therefore, simultaneous measurement of procainamide and NAPA serum concentration is critical in achieving optimal procainamide therapy.

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The provided text is an FDA 510(k) clearance letter for an in vitro diagnostic device, the N-Acetylprocainamide (NAPA) Enzyme Immunoassay. This letter primarily focuses on the regulatory clearance process, stating that the device has been found substantially equivalent to legally marketed predicate devices.

However, the document does NOT contain information about:

• Specific acceptance criteria used in a performance study.
• The results of such a study (device performance data).
• Any details regarding sample sizes (test or training sets).
• Data provenance.
• The number or qualifications of experts involved in establishing ground truth.
• Adjudication methods.
• Comparative effectiveness studies (MRMC).
• Standalone algorithm performance.
• The type of ground truth used or how ground truth for training data was established.

Therefore, I cannot provide the requested table or answer the specific questions based on the provided text. The document is strictly a regulatory clearance letter and does not delve into the technical study details that would typically be found in a 510(k) summary or the full submission.

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The Digoxin Immunoassay is intended for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity.

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria for the Digoxin Immunoassay.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the intended use of the Digoxin Immunoassay: "for in vitro diagnostic use for quantitative determination of digoxin concentrations in human serum or plasma. Accurate determination of digoxin concentrations provides critical information for clinical management of patients administered digoxin, aiding the physician in monitoring digoxin levels to determine the optimal digoxin dosage for effective therapy, while avoiding digoxin toxicity."

However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Information about sample sizes, data provenance, or details of a specific study.
3. Details regarding number or qualifications of experts, or adjudication methods.
4. Information on MRMC comparative effectiveness studies.
5. Details on standalone algorithm performance.
6. The type of ground truth used.
7. Sample size for the training set or how ground truth for the training set was established.

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The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.

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The provided text is a 510(k) premarket notification approval letter for the Vancomycin Enzyme Immunoassay. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission document itself, not in the FDA's approval letter.

Therefore, I cannot fulfill your request with the given input. The document is solely an approval stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

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The Multi-Drug Urine Calibrators and Controls are intended to be used for calibration and validation of DRI's drugs of abuse enzyme immunoassay to detect amphetamines, barbiturates, benzodiazepines, cocaine metabolites, methadone, methaqualone, opiates, phencyclidine and propoxyphene in human urine.

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This document is a marketing authorization letter from the FDA, it does not contain information about the acceptance criteria and study details. It permits the marketing of "Drugs of Abuse Urine Calibrators and Controls" and states its intended use, but does not provide any performance data, study design, or ground truth establishment methods. Therefore, I cannot extract the requested information from this document.

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This homogeneous lidocaine enzyme immunoassay is intended to be used for quantitative determination of lidocaine in human serum or plasma. Monitoring serum or plasma lidocaine concentration is the most effective means of improving the drug efficacy and minimizing the risk of toxicity for patients under lidocaine treatment for certain cardiac arrhythmias.

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The provided text is a 510(k) clearance letter from the FDA for a Lidocaine Enzyme Immunoassay. It determines the device is substantially equivalent to previously marketed devices. However, it does not contain specific details about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

Such information would typically be found in the 510(k) submission itself, or in supplementary documents that describe the studies conducted to demonstrate substantial equivalence. The clearance letter only states that the FDA reviewed the submission and determined substantial equivalence based on the indications for use.

Therefore, I cannot provide the requested information from the given text. A 510(k) clearance letter acknowledges the review and decision, but does not usually include the detailed study results or acceptance criteria.

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This 50 ng/mL cocaine metabolite urine calibrator is intended to be used for calibrating cocaine : metabolite enzyme immunoassay for qualitative and semi-quantitative determination of cocaine and its metabolites in human urine.

The assay results obtained with the cocaine metabolite enzyme immunoassay in combination with the use of such calibrator provide only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. Gas chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment 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 letter from the FDA regarding the clearance of a medical device, specifically a "50 ng/mL Cocaine Metabolite Urine Calibrator." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter only states that the device is substantially equivalent to legally marketed predicate devices and is cleared for marketing.

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

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This homogeneous methadone enzyme immunoassay is intended to be used for aualitative and semi-quantitative determination of methadone in human urine. The assay provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a confirmed analytical result. (નેકડ chromatograph/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment 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) premarket notification response letter from the FDA regarding a Methadone EIA Assay. This document does not describe the acceptance criteria for the device or the study that proves the device meets those criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.

Therefore, I cannot extract the requested information because it is not present in the provided text.

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Ask a specific question about this device

Ask a specific question about this device