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LiniCAL™ Protein 3 Calibration Verifiers Levels A - E for the Olympus AU Series Chemistry Immuno Analyzers™ is intended for use as an assayed quality control material for analysis.
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The provided text is an FDA 510(k) clearance letter for a medical device (LiniCAL™ Protein 3 Calibration Verifiers). It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain the acceptance criteria, study details, or performance data for the device.
FDA 510(k) clearance letters primarily focus on:
- Identifying the device and its intended use.
- Confirming substantial equivalence to a predicate device.
- Stating that the device can be legally marketed.
- Outlining regulatory requirements.
To answer your request, specific details regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparison studies are typically found in the 510(k) summary or the full 510(k) submission document, which is not provided here.
Therefore, I cannot provide the requested information based on the given text.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.