Sigma Diagnostics Auto D-Dimer, Model CRS126-A

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K003267 ↗

FDA Product Code

DAP

Device Class

Class II

Regulation

21 CFR Part 864.7320

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Diagnostics, Inc. →

• What is the Sigma Diagnostics Auto D-Dimer CRS126-A used for?

  The Sigma Diagnostics Auto D-Dimer CRS126-A is designed to detect and quantify D-dimer, a fibrin degradation product formed during clot breakdown. This helps clinicians assess intravascular coagulation and fibrinolysis, supporting diagnostic evaluations for conditions like deep vein thrombosis (DVT) or disseminated intravascular coagulation (DIC). By measuring D-dimer levels, it aids in ruling out or confirming hypercoagulable states where abnormal clot formation or dissolution may occur.

• How is the Sigma Diagnostics Auto D-Dimer CRS126-A supplied and intended for use?

  This device is supplied as a reagent kit specifically for automated immunoassay analyzers. It is intended for in vitro diagnostic use in clinical laboratories, meaning it is meant to be used by trained personnel in a controlled laboratory setting to analyze patient samples. The kit includes all necessary components for the assay, but it must be used in conjunction with compatible automated analyzers to perform the test.

• Is the Sigma Diagnostics Auto D-Dimer CRS126-A sterile or single-use?

  The device data does not specify explicit sterility requirements beyond standard laboratory practices. However, as an in vitro diagnostic reagent kit, it is typically handled under aseptic conditions to prevent contamination. While not explicitly labeled as single-use, the nature of reagent kits like this one generally assumes single-use per test cycle to maintain accuracy and prevent cross-contamination between samples. Always follow the manufacturer’s instructions for proper handling and storage.

• What storage and handling instructions should be followed for the Sigma Diagnostics Auto D-Dimer CRS126-A?

  The Sigma Diagnostics Auto D-Dimer CRS126-A must be stored and handled according to the manufacturer’s instructions to ensure accuracy and reliability. While specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data, reagent kits like this one typically require refrigeration or room-temperature storage, depending on the components included. It is critical to avoid exposure to extreme temperatures, direct sunlight, or contamination. Always check the accompanying documentation for precise storage guidelines to preserve the integrity of the assay reagents.

• What regulatory approvals does the Sigma Diagnostics Auto D-Dimer CRS126-A hold?

  The Sigma Diagnostics Auto D-Dimer CRS126-A has received FDA 510(k) clearance under the Hematology advisory committee, classifying it as a Class II device under regulation 864.7320. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting the necessary safety and performance standards for its intended use in diagnosing conditions related to fibrinogen and fibrin split products. For detailed regulatory information, refer to the FDA’s OpenFDA database or the manufacturer’s documentation.