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CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material.
CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are intended to evaluate the performance of assayed, liquid, quality control products on the Olympus AU Systems™.

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This is a 510(k) premarket notification for two types of quality control materials: "CLINIQA Liquid QC™ TDM Controls" and "CLINIQA LiniCAL™ TDM Calibration Verifiers." These devices are classified as Class I medical devices, which means they are subject to general controls but do not require extensive clinical trials or performance studies for market clearance. The FDA's review for such devices primarily focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than establishing specific performance criteria through a detailed study.

Therefore, the provided document does not contain the information requested regarding acceptance criteria, a specific study proving device performance against such criteria, sample sizes, expert qualifications, or detailed ground truth methodologies. These types of detailed performance studies are typically required for higher-risk devices (Class II or Class III) with more extensive regulatory requirements.

Here's why the requested information isn't present in this document:

• Device Type: Quality control materials (like controls and calibrators) are used to monitor the performance of diagnostic assays. Their "performance" is generally assessed by their stability, homogeneity, and their ability to produce expected values when tested on analytical systems, rather than their diagnostic accuracy in a clinical context.
• Regulatory Pathway (510(k)): The 510(k) pathway is for demonstrating substantial equivalence. This means the manufacturer shows their new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics and, if applicable, performance data to the predicate, but not necessarily establishing de novo acceptance criteria and proving performance against them in a large-scale study as would be needed for a novel diagnostic device.
• Absence of Clinical Study Data: The document is a clearance letter, not a full submission. For Class I devices, the submission itself would contain limited performance data, usually focusing on analytical performance (e.g., stability studies, target value assignments, matrix effects) rather than clinical accuracy or reader studies.

In summary, based on the provided FDA clearance letter, I cannot provide the requested information because it is not typically required or present for this type of device and regulatory pathway.

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