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Specialty Assayed CONTROL-2

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100103

by Helena Laboratories

Identifiers

510(k) Number
K100103 FDA 510(k)
FDA Product Code
GGC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 864.5425 FDA 510(k)
Regulation Number
864.5425 FDA 510(k)
Advisory Committee
Hematology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Specialty Assayed Control-2 is an in vitro coagulation control plasma designed for use with multipurpose coagulation testing systems. It is classified as an abnormal plasma control, intended to verify the performance and accuracy of coagulation assays by providing a reference standard with predefined abnormal coagulation parameters. This device supports laboratory validation of coagulation testing methods, ensuring reliable diagnostic results for conditions such as thrombophilia or bleeding disorders.

This control plasma is supplied as a liquid reagent, intended for single-use in clinical hematology laboratories. It is regulated under FDA 510(k) clearance (K100103) and falls under the classification of Class II medical devices (product code GGC). The device is intended for use with coagulation assays and is exempt from certain premarket notification procedures under specific regulatory conditions. Storage and handling instructions are not specified in the data but typically require refrigeration and protection from light to maintain stability.

Frequently asked questions

What is the Specialty Assayed Control-2 used for in a clinical lab?

The Specialty Assayed Control-2 is an abnormal plasma control designed to verify the performance and accuracy of coagulation assays. It provides predefined abnormal coagulation parameters, allowing laboratories to validate testing methods and ensure reliable diagnostic results for conditions like thrombophilia or bleeding disorders. By comparing test results against this reference standard, clinicians can confirm assay consistency and detect potential errors.

How is the Specialty Assayed Control-2 supplied and intended for use?

This device is supplied as a liquid reagent and is intended for single-use in clinical hematology laboratories. It is specifically engineered to work with multipurpose coagulation testing systems, ensuring compatibility with standard lab workflows. The liquid form allows for easy handling and immediate use without additional preparation steps.

Is the Specialty Assayed Control-2 sterile, and how should it be stored?

While the provided data does not explicitly state sterility, the Specialty Assayed Control-2 is formulated as a liquid reagent intended for direct use in clinical settings. For optimal stability and safety, it is recommended to store the control plasma refrigerated and protected from light, following standard practices for liquid plasma-based controls. Always refer to the manufacturer’s labeling for precise storage instructions.

Can the Specialty Assayed Control-2 be reused, or is it designed for single applications?

The Specialty Assayed Control-2 is explicitly intended for single-use only. Reusing a liquid plasma control could compromise accuracy due to potential contamination, degradation of components, or changes in coagulation parameters over time. Single-use design ensures consistent and reliable performance for each assay validation.

What regulatory pathway does the Specialty Assayed Control-2 follow, and what classification does it hold?

The Specialty Assayed Control-2 is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K100103). This classification indicates it is subject to general controls and special controls to ensure safety and effectiveness. The device is also exempt from certain premarket notification procedures under specific regulatory conditions, as outlined in its FDA submission.

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: SPECIALTY ASSAYED CONTROL-2 by HELENA LABORATORIES | FDA 510 (k) Summary, K941872 - Specialty Assayed Control-2 Cat. No. 5302, Coagulation | Helena Laboratories - Innovations for Science & Clinical ..., SPECIALTY ASSAYED CONTROL-2 (K100103) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Helena Laboratories

Sources (1)

  • FDA 510(k) K100103 24 fields · synced Oct 1, 2026