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1. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of DF3 defined antigen.
2. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of OC 125 defined antigen.
3. For in vitro use in verifying the calibration range of the VITROS Immunodiagnostic System when used for the measurement of PSA.

The VITROS Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum, plasma and urine, Coated microwells are used as the solid phase separation system. The system is comprised of three main elements: 1. The VITROS Immunodiagnostic Products (in this case VITROS Immunodiagnostic Products Reagent Pack, VITROS Immunodiagnostic Products Calibrators, which are combined by the VITROS Immunodiagnostic System to perform a VITROS assay). 2. The VITROS Immunodiagnostic System instrumentation, which provides automated use of the immunoassay kits. 3. Common reagents used by the VITROS System in each assay. The VITROS System and common reagents are dedicated specifically only for use with the VITROS Immunodiagnostic Products range of immunoassay products.

The provided document is a 510(k) summary for "VITROS Immunodiagnostic Products CA 15-3 Range Verifiers, VITROS Immunodiagnostic Products CA 125 II Range Verifiers, and VITROS Immunodiagnostic Products PSA Range Verifiers."

This document describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. It does not present acceptance criteria for device performance or a study proving that the device meets such criteria. Instead, the submission focuses on demonstrating substantial equivalence based on physical properties, intended use, and comparison with a previously cleared predicate device (VITROS Immunodiagnostic Products FSH Range Verifiers, K973517).

Therefore, I cannot extract the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment from this submission. These details would typically be found in a performance study report, which is not part of this 510(k) summary.

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