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CryoCheck Weak Lupus Positive Control

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032804

by Precision Biologic

Identifiers

510(k) Number
K032804 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 CryoCheck Weak Lupus Positive Control is a plasma-based control designed for use in lupus anticoagulant (LA) assays. It serves as a weak positive reference material to validate the sensitivity of diagnostic tests for detecting weak LA in patient samples. This control is classified as an abnormal plasma control, specifically intended for hematological testing.

This product is supplied as a lyophilized plasma control, intended for single-use in laboratory settings. It is not sterile or sterile-filtered and requires reconstitution prior to use. The device is regulated under FDA 510(k) clearance (K032804) and falls under Class II medical devices. Storage conditions and expiration dates are specified on the packaging.

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: Weak Lupus Positive Control - Precision BioLogic, PDF Lupus Positive Control and Weak Lupus Positive Control Lupus Negative ..., CRYOcheck™ Weak Lupus Positive Control - Cryopep, PDF SECTION V 51 O(K) CryoCheck Weak Lupus Positive Control

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Precision Biologic

Sources (1)

  • FDA 510(k) K032804 24 fields · synced Oct 1, 2026