(20 days)
IMMULITE Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with IMMULITE and IMMULITE 2000 Third Generation PSA assays. It is intended as an aid in monitoring day-to-day assay performance.
DPC's IMMULITE® Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with both the IMMULITE® and IMMULITE 2000® Third Generation PSA assays.
The provided document is a 510(k) summary for the IMMULITE® Third Generation PSA Control Module. It explicitly states that "Clinical Studies: Not applicable" and "The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in againting DPC substantial equivalence for IMMULITE® T Generation PSA Control Module." This indicates that the device's acceptance was based on substantial equivalence to a predicate device, not on clinical performance studies proving specific acceptance criteria related to a device's performance in diagnosing, detecting, or treating a condition.
Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria (e.g., sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) cannot be extracted from this document, as such studies were not conducted or reported for this submission.
The device is a control module for an assay, used to monitor the day-to-day performance of the assay itself, rather than a diagnostic device for which clinical performance metrics like sensitivity or specificity would typically be evaluated in a study. Its function is to provide known values to ensure the assay is working correctly.
§ 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.