Buffer, Collagen Reagent and Diluent (JBX)

Full name

Buffer, Collagen Reagent and Diluent

510(k) Number

K781710 ↗

FDA Product Code

JBX

Device Class

Class II

Regulation

21 CFR Part 864.6675

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Buffer, Collagen Reagent and Diluent used for in a clinical setting?

  This device is specifically designed as an accessory for platelet aggregometers, serving as a reagent and diluent to prepare collagen solutions. It is used in platelet aggregation testing—a critical hematology procedure—to evaluate how well blood clots, helping diagnose or monitor conditions affecting clotting function.

• Is this product intended for single-use or can it be reused?

  The Buffer, Collagen Reagent and Diluent is explicitly labeled for single-use only in laboratory settings. Since it is supplied as a 10 ml 10X concentrate, reuse would compromise accuracy and sterility, which are essential for reliable platelet aggregation testing.

• How should this reagent be prepared before use?

  Before use, the 10 ml 10X concentrate must be diluted with distilled water to achieve the appropriate concentration for collagen solution preparation. The exact dilution ratio isn’t specified in the data, but proper dilution is necessary to ensure accurate platelet aggregation testing results.

• What regulatory pathway does this device follow, and what class is it assigned?

  This device follows the FDA’s 510(k) clearance pathway and is classified as a Class II device under FDA nomenclature (Product Code: JBX). It was determined to be *substantially equivalent* to a predicate device and received clearance under the *Traditional* review process, with the advisory committee HE (Hematology) involved in its evaluation.

• Are there any special storage requirements mentioned for this reagent?

  The regulatory submission does not specify storage conditions (e.g., temperature, light exposure) for the Buffer, Collagen Reagent and Diluent. However, since it is a laboratory reagent, standard practice would recommend storing it in a cool, dry place away from direct sunlight until use, as with most chemical concentrates.