REAADS Monoclonal Free Protein S Antigen Test Kit

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

510(k) Number

K983914 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Corgenix, Inc. →

• What clinical condition is this test kit designed to help evaluate, and how does it function?

  This test kit is designed to help assess coagulation disorders by quantitatively measuring Free Protein S Antigen levels in human plasma. Free Protein S is a natural anticoagulant, and its deficiency can contribute to thrombotic conditions. The REAADS kit uses an enzyme-linked immunosorbent assay (ELISA) method to determine Free Protein S levels as a percentage of normal concentration, aiding in the diagnosis of factor deficiency-related disorders.

• Is this test kit reusable, or is it intended for single-use only?

  The REAADS Monoclonal Free Protein S Antigen Test Kit is explicitly supplied as a single-use kit. Each kit is designed for one test cycle, ensuring accuracy and preventing cross-contamination between samples.

• What type of sample is required for this test, and how should it be prepared?

  This test requires citrated human plasma as the sample. The plasma must be prepared from whole blood collected in a citrate anticoagulant tube, as the test is not intended for use with whole blood or other sample types.

• How should the test kit be stored to maintain its integrity before use?

  The test kit must be stored according to the manufacturer’s instructions to preserve its integrity. While specific storage conditions (e.g., temperature, humidity) are not detailed here, adherence to Corgenix’s guidelines ensures the kit remains stable and functional until use.

• What regulatory pathway was followed for this device’s clearance, and which advisory committee was involved?

  The REAADS kit received FDA clearance through a traditional 510(k) pathway, classified as substantially equivalent under the Hematology advisory committee (HE). This means it was reviewed by the Hematology Expert Panel to ensure compliance with safety and performance standards for coagulation-related diagnostic tests.