Mesacup Test MPO, Model 11053

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K040586 ↗

FDA Product Code

MOB

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• What clinical specialty is the Mesacup Test MPO, Model 11053, primarily used in, and how does it assist in patient evaluation?

  The Mesacup Test MPO, Model 11053, is designed for use in immunology, specifically to detect IgG anti-myeloperoxidase (MPO) antibodies in human serum. These antibodies are associated with certain autoimmune conditions, such as vasculitis, helping clinicians refine diagnostic evaluations in patients suspected of having ANCA-related diseases. The semi-quantitative ELISA format provides measurable results to aid in differential diagnosis.

• Is the Mesacup Test MPO, Model 11053, intended for in-office use or must it be performed in a clinical laboratory setting?

  The device is explicitly intended for use in clinical laboratory settings only, not for point-of-care or in-office testing. This is due to its classification as a diagnostic test system requiring controlled conditions, proper handling, and adherence to laboratory protocols to ensure accurate and reliable results.

• How is the Mesacup Test MPO, Model 11053, supplied, and is it reusable or single-use?

  The Mesacup Test MPO, Model 11053, is supplied as a single-use diagnostic test kit. Each kit is designed for one test cycle, ensuring sterility and consistency of results. Reuse is not recommended or supported by the manufacturer, as it could compromise accuracy or introduce contamination.

• What regulatory pathway was followed for FDA clearance of the Mesacup Test MPO, Model 11053, and what does this mean for its use?

  The device underwent a traditional 510(k) clearance process through the FDA, classified as substantially equivalent (SESE) under regulation 866.5660 and reviewed by the Immunology (IM) Advisory Committee. This means the manufacturer demonstrated that the device is as safe and effective as a legally marketed predicate device, allowing its use in clinical settings for the intended purpose of detecting IgG anti-MPO antibodies in human serum.