Shield Diastat ANTI-B2 Glycoprotein 1 IgG (ELISA) Assay

• • Terminated Z-0674-05 FDA Unclassified (pre-2012) ·initiated 26 Oct 2004

  Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.

510(k) Number

K982879 ↗

FDA Product Code

MSV

Device Class

Class II

Regulation

21 CFR Part 866.5660

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Shield Diagnostics, Ltd. →

• What is the Shield Diastat Anti-B2 Glycoprotein 1 IgG (ELISA) Assay used for?

  This assay is designed for detecting IgG autoantibodies against ß2-glycoprotein 1 in human serum or plasma. It is intended for use in clinical laboratory settings by trained personnel to perform diagnostic testing.

• How is the Shield Diastat Anti-B2 Glycoprotein 1 IgG Assay supplied?

  The assay is supplied as a test system for laboratory use. It is intended for single-use applications and should be used according to the manufacturer's instructions by trained personnel in clinical laboratory settings.

• What is the regulatory status of the Shield Diastat Anti-B2 Glycoprotein 1 IgG Assay?

  The device is authorized under FDA 510K clearance with product code MSV and is classified as Class II. It received FDA clearance through the traditional pathway with a decision code of SESE, indicating it is substantially equivalent to other devices on the market.

• Is the Shield Diastat Anti-B2 Glycoprotein 1 IgG Assay MRI safe?

  The device is not specified as MRI safe in the provided data. Users should consult the manufacturer's instructions for specific information regarding MRI compatibility and safety considerations.