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These are qualitative calibrators/controls to confirm the presence of antibodies to autoantigens (Jo-1, Scl-70, or PCNA) in human serum. Antibodies to Jo-1 are found in patients with polymyositis and dermatomyositis, antibodies to Scl-70 are found in patients with scleroderma, and antibodies to PCNA are found in patients with systemic lupus erythematosus. These optional controls are intended for use with the Immuno Concepts AUTO-ID® Autoantibody Test System.

AUTO-I.D.® Jo-1 Positive Control Serum (Catalog number 6004) AUTO-I.D.® Sc1-70 Positive Control Serum (Catalog number 6005) AUTO-I.D.® PCNA Positive Control Serum (Catalog number 6006)

This document is a 510(k) premarket notification approval letter for the Immuno Concepts Incorporated's Auto I.D.® Jo-1, Scl-70, and PCNA Positive Controls. It indicates the products are substantially equivalent to legally marketed predicate devices. This type of document does not contain details about specific acceptance criteria or an in-depth study proving device performance against those criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence, not necessarily to provide detailed performance studies in the way you might find for a novel, high-risk device. The approval letter confirms the device can be legally marketed, but it doesn't typically elaborate on the specific performance study results that were part of the submission package.

Therefore, I cannot provide the requested information because the provided text does not contain it. The text focuses on the regulatory approval, indicating the device is a "qualitative calibrator/control to confirm the presence of antibodies to autoantigens." This implies performance validation related to its role as a control, likely confirming the presence of the respective antibodies, but the details of such validation are not in this approval letter.

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