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AESKU PR3 Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091859

by Aesku Diagnostics

Identifiers

510(k) Number
K091859 FDA 510(k)
FDA Product Code
MOB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5660 FDA 510(k)
Regulation Number
866.5660 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AESKU PR3 Test System is a solid-phase enzyme-linked immunosorbent assay (ELISA) designed for the qualitative and quantitative detection of antibodies against proteinase 3 (PR3) in human serum. It employs highly purified native human PR3 derived from neutrophil granulocytes to identify anti-PR3 antibodies, which target conformational epitopes accessible only on the native protein. This system is classified under the device type 'Test System, Antineutrophil Cytoplasmic Antibodies (ANCA)' and is used primarily in immunology diagnostics.

The device is supplied as a single-use diagnostic kit and is intended for use in clinical laboratory settings. It requires no special storage conditions beyond refrigeration at 2–8°C and is not intended for MRI environments. The system is authorized under FDA 510(k) clearance (K091859) and falls under device class II. No information regarding reusability or sterility beyond standard single-use diagnostic kit protocols is provided in the specifications.

Frequently asked questions

What clinical setting is the AESKU PR3 Test System intended for, and why is this important for my lab?

The AESKU PR3 Test System is designed exclusively for use in clinical laboratory settings, where trained personnel can perform enzyme-linked immunosorbent assays (ELISA). This is important because it ensures proper handling, interpretation, and compliance with diagnostic protocols. The system detects anti-PR3 antibodies, which are critical for diagnosing conditions like vasculitis, so accuracy and controlled environments are essential.

Is the AESKU PR3 Test System reusable, or is it meant for single-use only? How does this affect my workflow?

The AESKU PR3 Test System is supplied as a single-use diagnostic kit, meaning each kit is intended for one test cycle only. This design minimizes cross-contamination risk and ensures consistent, reliable results. For your workflow, this means you’ll need to account for kit disposal after use and plan accordingly to avoid interruptions.

What storage conditions are required for the AESKU PR3 Test System, and how might this impact inventory management?

The system requires standard refrigeration at 2–8°C—no additional storage precautions are needed. This makes it practical for most clinical labs, as refrigeration is commonly available. However, ensure proper inventory rotation to avoid expiration, and monitor temperature logs if required by your facility’s protocols.

Does the AESKU PR3 Test System detect specific types of antibodies, and why does this matter for patient diagnosis?

Yes, the AESKU PR3 Test System specifically detects antibodies against proteinase 3 (PR3), which are a subset of antineutrophil cytoplasmic antibodies (ANCA). These antibodies are strongly associated with conditions like Wegener’s granulomatosis (now classified as granulomatosis with polyangiitis), so accurate detection is critical for diagnosing and managing autoimmune-related vasculitis.

What regulatory pathway does the AESKU PR3 Test System follow, and how does this affect its use in my facility?

The AESKU PR3 Test System is authorized under FDA 510(k) clearance (K091859), meaning it has been deemed substantially equivalent to a predicate device and classified as Class II. This classification indicates it undergoes rigorous review for safety and effectiveness, ensuring reliability for clinical use. Your facility can confidently incorporate it into immunology diagnostics workflows without additional regulatory hurdles.

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: AESKULISA® ELISA Test Kits - AESKU We take care of your health, 3302 PR3 sensitive - AESKU.GROUP - Experts in Diagnostics, Aesku.Diagnostics GmbH & Co. KG 30-7302US AESKULISA® PR3 sensitive

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Aesku Diagnostics

Sources (1)

  • FDA 510(k) K091859 24 fields · synced Oct 6, 2026