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Helena AT-III Quiplate Procedure

FDA 510(k)

Class II (US FDA 510(k))

510(k) K802912

by Helena Laboratories

Identifiers

510(k) Number
K802912 FDA 510(k)
FDA Product Code
JBQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.7060 FDA 510(k)
Regulation Number
864.7060 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Helena AT-III Quiplate Procedure is a diagnostic test classified as Antithrombin III Quantitation, used to measure levels of antithrombin III in blood plasma. Antithrombin III is a naturally occurring anticoagulant that regulates blood clotting, and its quantification aids in the diagnosis and management of conditions such as thrombophilia, liver disease, or disseminated intravascular coagulation (DIC).

This procedure is performed in clinical hematology laboratories and is designed for single-use. It adheres to FDA 510(k) clearance (K802912) under Special Controls (Regulation 864.7060) and is categorized under Class II medical devices. Supplied as a kit, it requires proper storage and handling as specified in the accompanying instructions. The procedure is intended for in vitro diagnostic use only.

Frequently asked questions

What clinical conditions is the Helena AT-III Quiplate Procedure primarily used to diagnose or monitor?

This test measures antithrombin III levels in blood plasma to aid in diagnosing and managing conditions like thrombophilia (inherited blood clotting disorders), liver disease, and disseminated intravascular coagulation (DIC). Since antithrombin III is a natural anticoagulant, its quantification helps clinicians assess clotting risks or deficiencies.

Is the Helena AT-III Quiplate Procedure intended for single-use or repeated testing, and how should it be handled?

The procedure is explicitly designed for single-use only, meaning each kit should not be reused after opening. Proper storage and handling must follow the instructions provided in the kit to maintain accuracy and reliability of results.

Where is this device used, and what type of laboratory setting is it intended for?

The Helena AT-III Quiplate Procedure is intended for use in clinical hematology laboratories only. It is not meant for point-of-care or home testing but requires specialized laboratory equipment and trained personnel to perform the assay.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

This device received FDA 510(k) clearance (K802912) under Special Controls (Regulation 864.7060) and is classified as a Class II medical device. The clearance was granted through a traditional review process by the Hematology (HE) Advisory Committee, ensuring it meets established safety and performance standards for in vitro diagnostic 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: K802912 FDA 510(k) - HELENA AT-III QUIPLATE PROCEDURE, HELENA AT-III QUIPLATE PROCEDURE (K802912) - Innolitics, Helena At-iii Quiplate Procedure 510 (k) K802912 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K802912 24 fields · synced Sep 19, 2026