APTT Reagent

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K904341 ↗

FDA Product Code

GFO

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sigma Chemical Co. →

• What is the APTT Reagent used for in clinical settings?

  The APTT Reagent is designed to measure the activated partial thromboplastin time (APTT), a critical blood test that evaluates the intrinsic and common pathways of coagulation. Clinicians use it to diagnose coagulation disorders, monitor patients on anticoagulant therapy (such as heparin), and identify deficiencies in specific clotting factors like Factor VIII or Factor IX. This helps guide treatment decisions for conditions like hemophilia or disseminated intravascular coagulation (DIC).

• How is the APTT Reagent supplied and intended for use?

  The APTT Reagent is supplied as a single-use diagnostic tool, meaning each vial is intended for one test to ensure accuracy and prevent cross-contamination. It is exclusively for use in clinical laboratories, where trained personnel follow standard laboratory practices for handling, storage, and testing. This ensures reliable results for patient care.

• Is the APTT Reagent sterile, and how should it be stored?

  The APTT Reagent is not explicitly described as sterile in the provided data, but as a diagnostic reagent intended for laboratory use, it should be handled under aseptic conditions to avoid contamination. Storage instructions are not detailed, but generally, reagents like this are stored at room temperature (15–30°C) in a dry place, protected from light and extreme temperatures. Always refer to the manufacturer’s label for precise storage guidelines.

• Can the APTT Reagent be reused, or is it disposable?

  The APTT Reagent is intended for single-use only. Reusing it could compromise test accuracy due to potential degradation of reagents or contamination, leading to unreliable results. Single-use design aligns with best practices in laboratory diagnostics to ensure patient safety and data integrity.

• What regulatory pathway was followed for FDA clearance of this device?

  The APTT Reagent was cleared through the Traditional 510(k) pathway by the FDA in 1990 under clearance number K904341. It is classified as a Class 2 device with product code GFO, indicating it poses moderate risk and requires general controls (e.g., labeling, performance standards) but not as stringent oversight as Class 3 devices. The clearance was based on a determination of substantial equivalence to a predicate device.