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Elecsys FSH CalSet II

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003409

by Roche Diagnostics Corp.

Identifiers

510(k) Number
K003409 FDA 510(k)
FDA Product Code
JIT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1150 FDA 510(k)
Regulation Number
862.1150 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Elecsys FSH CalSet II is a secondary calibrator designed for use with electrochemiluminescence immunoassay (ECLIA) systems. It provides quantitative calibration standards for measuring follicle-stimulating hormone (FSH) levels in human serum and plasma, supporting accurate diagnostic testing in clinical chemistry applications.

This calibrator is intended for use with the Elecsys and cobas e immunoassay analyzers. Supplied as a sterile, single-use product, it is regulated under FDA 510(k) clearance (K003409) and falls under the classification of a Class II device (regulation number 862.1150). It is not intended for MRI use and must be stored according to manufacturer instructions to maintain stability and performance.

Frequently asked questions

What is the Elecsys FSH CalSet II used for?

The Elecsys FSH CalSet II is a secondary calibrator designed specifically for quantitative calibration of follicle-stimulating hormone (FSH) measurements in human serum and plasma. It supports accurate diagnostic testing on Roche’s electrochemiluminescence immunoassay (ECLIA) systems, including the Elecsys and cobas e analyzers. This ensures reliable FSH level assessments for clinical chemistry applications.

How is the Elecsys FSH CalSet II supplied and what are its sterility and usage guidelines?

The Elecsys FSH CalSet II is supplied as a sterile, single-use product. Sterility is maintained through manufacturing controls, and it is intended for one-time use only to prevent contamination and ensure consistent calibration performance. Always follow the manufacturer’s instructions for storage and handling to preserve stability and accuracy.

Is the Elecsys FSH CalSet II compatible with all Roche immunoassay analyzers?

No, the Elecsys FSH CalSet II is explicitly designed for use with Roche’s ECLIA systems, including the Elecsys and cobas e immunoassay analyzers. It is not compatible with non-Roche platforms or MRI-compatible devices. Always verify compatibility with your analyzer model before use.

What storage conditions are required to maintain the calibrator’s performance?

The Elecsys FSH CalSet II must be stored according to the manufacturer’s instructions to maintain stability and performance. Typically, this includes refrigeration (e.g., 2–8°C) and protection from light and extreme temperatures. Check the packaging or Roche’s documentation for specific storage guidelines to avoid degradation or inaccurate calibration results.

What regulatory pathway does the Elecsys FSH CalSet II follow?

The Elecsys FSH CalSet II is regulated under the FDA’s 510(k) clearance pathway, classified as a Class II medical device under regulation number 862.1150. It was determined to be substantially equivalent to a predicate device through an abbreviated review process by the Clinical Chemistry Advisory Committee (CH). This classification reflects its role as a secondary calibrator for 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: Elecsys® FSH - Roche Diagnostics USA, Elecsys® FSH - Roche Diagnostics USA, ELECSYS FSH CALSET II (K003409) — 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) K003409 24 fields · synced Oct 1, 2026