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Elecsys PTH Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070391

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K070391 FDA 510(k)
FDA Product Code
CEW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1545 FDA 510(k)
Regulation Number
862.1545 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Elecsys PTH Test System is an electrochemiluminescence immunoassay (ECLIA) device designed for the in vitro quantitative measurement of intact parathyroid hormone (PTH) in human serum and plasma. It falls under the category of radioimmunoassay systems and is classified as a Class II medical device, enabling precise diagnostic evaluation for conditions such as hypercalcemia and hypocalcemia.

This system is intended for use on Elecsys and cobas e immunoassay analyzers, supporting intraoperative monitoring where applicable. Supplied as a sterile, single-use reagent system, it requires no additional sterilization and is regulated under FDA 510(k) clearance (K070391) and CE marking (CEW). Storage and handling follow standard immunoassay protocols to maintain assay integrity.

Frequently asked questions

What types of analyzers is the Elecsys PTH Test System designed to work with, and how does this affect intraoperative monitoring capabilities?

The Elecsys PTH Test System is specifically designed for use on Roche Diagnostics’ Elecsys and cobas e immunoassay analyzers. This compatibility ensures precise and reliable measurement of intact parathyroid hormone (PTH) in real-time, which is particularly valuable for intraoperative monitoring. The system’s integration with these analyzers allows for seamless workflow integration during surgeries, enabling clinicians to quickly assess PTH levels and make informed decisions during procedures.

Is the Elecsys PTH Test System intended for single-use or reusable applications, and what does this mean for handling and cost management?

The Elecsys PTH Test System is supplied as a sterile, single-use reagent system. This design eliminates the need for additional sterilization between uses, reducing the risk of contamination and simplifying handling protocols. For cost management, single-use systems can help minimize inventory and waste management challenges, as each test requires a fresh reagent kit, ensuring consistent performance without the need for cleaning or reprocessing.

What storage and handling requirements must be followed to maintain the integrity of the Elecsys PTH Test System’s assays?

The Elecsys PTH Test System follows standard immunoassay protocols for storage and handling to preserve assay integrity. While specific storage conditions (e.g., temperature, humidity) are not detailed here, it is critical to adhere to the manufacturer’s guidelines—typically involving refrigeration or room-temperature storage as indicated on the packaging—to prevent degradation of the reagents. Proper handling ensures accurate and reliable PTH measurements, which are essential for diagnosing conditions like hypercalcemia or hypocalcemia.

How does the regulatory pathway for the Elecsys PTH Test System impact its availability or use in clinical settings?

The Elecsys PTH Test System has received FDA 510(k) clearance (K070391) and a CE marking (CEW), indicating it meets regulatory standards for safety and effectiveness in the U.S. and European markets, respectively. This clearance allows healthcare providers to confidently incorporate the system into their diagnostic workflows, ensuring compliance with local regulations while leveraging its validated performance for PTH measurement. The classification as a Class II device further underscores its rigorous evaluation for clinical 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: Elecsys® PTH - Roche Diagnostics USA, Elecsys® PTH - Roche Diagnostics USA, ROCHE ELECSYS PTH TEST SYSTEM (K070709) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA 510(k) K070391 24 fields · synced Sep 19, 2026