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The NOD™ Chemistry Control is a two-level control set that is intended for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for the analytes listed in the package insert (routine chemistries).

The NOD™ Chemistry Control is a two-level control set.

This document is a 510(k) premarket notification for a medical device called "NOD™ Chemistry Control." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document is a clearance letter from the FDA, confirming that Bioresource Technology, Inc. can market their NOD™ Chemistry Control. It specifies the regulation number, regulation name, regulatory class, and product code. The "Indications for Use" section states that the device is a two-level control set for in-vitro diagnostic use to monitor the precision of laboratory testing procedures for routine chemistries.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study that proves the device meets them based on the provided input.

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NOVA-ONE Control is intended for use in the laboratory to monitor the accuracy and rrovit one of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.

NOVA-ONE Lipid Control Human Liquid Lipid Control

This document is an FDA 510(k) clearance letter for a quality control material (NOVA-ONE Lipid Control Human Liquid Lipid Control). It does not contain information about acceptance criteria or a study proving device performance as typically expected for medical AI/imaging devices.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided text does not contain this type of data. The letter simply states that the device is substantially equivalent to legally marketed predicate devices, which is a regulatory determination for a quality control material and not a performance study as described in your request.

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Liquid Human Glycosylated Hemoglobin (A1C) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (A1C) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.

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The provided text is a government letter concerning the substantial equivalence determination for a medical device called "Glycosylated Hemoglobin A1C Control Normal and Elevated." It informs the manufacturer that they can market the device.

However, the document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is solely an administrative notification of regulatory clearance.

Therefore, I cannot provide the requested table and study details based on the input text.

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