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The Diastat anti-ß, Glycoprotein1 IgG Test is a semi-quantitative enzyme immunoassay for the detection, in human serum or plasma (citrate or EDTA anticoagulated), of the IgG class of autoantibodies specific for B,GP1 Antigen. The test is intended for use as an aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such a primary anti-phospholipid syndrome, or secondary to Systemic Lupus Erythematosus. The test results are not definitive in isolation and represent one parameter in a multi-criterion diagnostic process. The option of a qualitative protocol is also available.

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The provided text is a 510(k) clearance letter for the Shield DIASTAT anti-B2 Glycoprotein 1 IgG (ELISA) Assay. It confirms the device's substantial equivalence to a legally marketed predicate device. However, this document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information on sample sizes, data provenance for test sets, and details about ground truth establishment.
• Details regarding expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
• Results from standalone algorithm performance, or information about the training set.

The letter focuses on the regulatory clearance process and confirms that the device can be marketed based on its substantial equivalence. To answer your questions, one would need to access the actual 510(k) submission (K982879) which would contain the performance data and study details.

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