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ADP REAGENT

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910800

by Helena Laboratories

Identifiers

510(k) Number
K910800 FDA 510(k)
FDA Product Code
GHR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5700 FDA 510(k)
Regulation Number
864.5700 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ADP REAGENT is a lyophilized preparation of adenosine-5-diphosphate used in routine platelet aggregation studies for the evaluation of qualitative platelet function disorders. It is classified as a Reagent, Platelet Aggregation under product code GHR and is intended for use with an impedance cell counter and Plateletworks reagent tubes to assess platelet function.

The reconstituted ADP reagent has a concentration of 200 μM and is supplied in a format of 2 x 1 mL vials. It is used to screen pre-surgical and trauma patients for adequate platelet function and to monitor the effects of anti-platelet therapies. The device received FDA 510(k) clearance (K910800) and is classified as a Class II device under regulation number 864.5700.

Frequently asked questions

What is ADP REAGENT used for?

ADP REAGENT is used in routine platelet aggregation studies to evaluate qualitative platelet function disorders, screen pre-surgical and trauma patients for adequate platelet function, and monitor the effects of anti-platelet therapies when used with an impedance cell counter and Plateletworks reagent tubes.

How is ADP REAGENT supplied and prepared for use?

ADP REAGENT is supplied as a lyophilized preparation in a format of 2 x 1 mL vials. It must be reconstituted before use, resulting in a final concentration of 200 μM adenosine-5-diphosphate for platelet aggregation testing.

Is ADP REAGENT sterile or single-use?

The provided data does not specify whether ADP REAGENT is sterile or intended for single-use or reuse. Information about sterility, single-use designation, or reuse limitations is not included in the device data and should be obtained from the manufacturer’s labeling or instructions for use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Plateletworks | Helena Laboratories - Innovations for Science ..., Platelet Aggregation | Helena Laboratories - Innovations for Science ..., K952252 FDA 510 (k) - ADP REAGENT | Helena Laboratories

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K910800 24 fields · synced Sep 25, 2026