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K Number
K091860
Device Name
AESKULISA MPO, MODEL 30-7303US
Manufacturer
AESKU.DIAGNOSTICS
Date Cleared
2010-02-23

(249 days)

Product Code
MOB
Regulation Number
866.5660
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AESKULISA MPO is a solid phase enzyme immunoassay employing purified native myeloperoxidase (MPO) from human peripheral blood polymorphonuclear cells for the semiquantitative and qualitative detection of antibodies against MPO in human serum.

The assay is an aid in the diagnosis of autoimmune systemic vasculitis such as microscopic polyangiitis, and glomerulonephritis and should be used in conjunction with other laboratory and clinical findings.

Device Description

AESKULISA MPO is a solid phase enzyme immunoassay.

AI/ML Overview

The provided text is a letter from the FDA regarding the 510(k) premarket notification for the AESKULISA MPO device. While it states that the device is substantially equivalent to legally marketed predicate devices and mentions its intended use, it does not contain the detailed study results, acceptance criteria, or other specific information requested in the prompt for proving the device meets acceptance criteria.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
  6. If a standalone performance (algorithm only) was done
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document primarily focuses on the regulatory approval process and the "Indications for Use" for the AESKULISA MPO device. It does not include the technical details of the performance study that would be necessary to address your specific questions about acceptance criteria and study data.

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).