Chromostrate Antithrombin III Assay

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Gen. Diag. Chromostrate Antithrombin III Assay

510(k) Number

K850412 ↗

FDA Product Code

JBQ

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Chromostrate Antithrombin III Assay used for?

  This assay quantifies antithrombin III, a plasma protein that regulates blood coagulation. Low levels are associated with thromboembolic disorders, so the test helps diagnose and monitor coagulation-related conditions in patients.

• Is the Chromostrate Antithrombin III Assay single-use or reusable?

  The assay is supplied as a single-use diagnostic reagent. Each kit is designed for one-time use to ensure accurate and reliable results, requiring validation per standard laboratory protocols before each run.

• How should the Chromostrate Antithrombin III Assay be stored?

  Storage and handling must follow the manufacturer’s instructions to preserve assay integrity. While no specific sterility or MRI safety requirements are noted, proper conditions (e.g., temperature, humidity) are critical to maintain reagent stability and test validity.

• Does the Chromostrate Antithrombin III Assay require special handling for sterility?

  The device is not labeled with sterility requirements in regulatory records, but standard laboratory practices for in vitro diagnostics should be followed. Since it’s a single-use reagent, contamination risks are mitigated by proper storage and usage protocols.

• What regulatory clearance does the Chromostrate Antithrombin III Assay hold?

  The assay holds FDA 510(k) clearance (K850412) under product code JBQ, classified as a Class II medical device. This clearance confirms it is substantially equivalent to a predicate device for quantitating antithrombin III in clinical settings.