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K Number
K062217
Device Name
AESKULSKA BETA2-GLYCO-A
Manufacturer
AESKU, INC
Date Cleared
2006-12-13

(134 days)

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

AESKULISA ß2 Glyco-A is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

AESKULISA ß2 Glyco-GM is a solid phase enzyme immunoassay employing native ß2 glycoprotein I highly purified from human plasma for the separate semiquantitative and qualitative detection of IgG and/or IgM antibodies against β2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

AESKULISA ß2 Glyco-Check is a solid phase enzyme immunoassay employing native ß2 glycoprotein 1 highly purified from human plasma for the combined semiquantitative and qualitative detection of IgA, IgG and IgM antibodies against ß2 glycoprotein I in human serum. The presence of anti-ß2 glycoprotein I antibodies in conjunction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them in the format you requested. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the intended use of the devices (AESKULISA® ß2-Glyco-A, AESKULISA® ß2-Glyco-GM, AESKULISA® ß2-Glyco-Check) for detecting antibodies related to antiphospholipid syndrome.

However, the letter does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample size for test sets or their data provenance.
  3. Information on the number or qualifications of experts used for ground truth.
  4. Adjudication methods.
  5. Results of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  6. Results of standalone algorithm performance studies.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. The sample size for the training set.
  9. How ground truth for the training set was established.

This document serves as a regulatory clearance notice, not a detailed study report or clinical trial summary. To get the information you are looking for, you would typically need to consult the full 510(k) submission, the device's labeling, or peer-reviewed publications related to the device.

§ 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).