(57 days)
The Real-Time PCR Internal Control 2B Set consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control 2B Set can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
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The provided document is a 510(k) premarket notification letter from the FDA to Nanogen, Inc. regarding their Real-Time PCR Internal Control 2B Set. This document does not contain information about acceptance criteria, study details, or performance data of the device.
The letter states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and other requirements under the Federal Food, Drug, and Cosmetic Act. The "Indication for Use" section describes the intended purpose of the device as an unassayed internal extraction and amplification process control in real-time PCR assays.
Since the provided text is a regulatory clearance letter and not a study report or a detailed submission, it lacks the specific information requested in your prompt regarding acceptance criteria and device performance studies. Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or multi-reader studies.
§ 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.