(78 days)
LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array® Protein Systems is intended for use as an assayed quality control material for analysis.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the LiniCAL™ Protein 2 Calibration Verifiers. It states that the device is substantially equivalent to legally marketed predicate devices and is intended for use as an assayed quality control material.
The text does not contain:
- A table of acceptance criteria or reported device performance.
- Details on sample sizes, data provenance, number of experts, their qualifications, or adjudication methods for test sets.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
- Details about the type of ground truth used or how ground truth for training sets was established.
Therefore, I cannot provide a response that includes the requested information based on the input given.
§ 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.