Identifiers
- 510(k) Number
- K002148 FDA 510(k)
- FDA Product Code
- DHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys HCG Test System is an in vitro diagnostic device classified as a human chorionic gonadotropin (hCG) test system, designed for the quantitative measurement of hCG in serum or plasma. It employs an electrochemiluminescence immunoassay (ECLIA) to detect and monitor hCG levels, which are clinically relevant for pregnancy detection and the assessment of hCG-producing tumors, including ovarian, placental, or testicular malignancies. The system provides rapid and sensitive detection of hCG, including its various forms such as the holo-hormone, nicked forms, and β-core fragments.
This system is intended for use on Elecsys and cobas e immunoassay analyzers, including models such as the cobas e 801. It is supplied as a reusable diagnostic analyzer system with disposable test reagents, requiring no additional sterilization beyond manufacturer-provided protocols. The device is not single-use and operates within Class II (Moderate Risk) regulatory classification under FDA 510(k) clearance (K002148). Storage and handling follow standard laboratory practices for immunoassay systems, with compliance ensured through FDA-authorized distribution channels.
Frequently asked questions
What clinical applications does the Elecsys HCG Test System support?
The Elecsys HCG Test System is designed for the quantitative measurement of human chorionic gonadotropin (hCG) in serum or plasma, enabling detection of pregnancy and monitoring of hCG-producing tumors such as ovarian, placental, or testicular malignancies. It detects multiple hCG forms, including holo-hormone, nicked variants, and β-core fragments, providing comprehensive clinical insights.
How is the Elecsys HCG Test System supplied and what are its key components?
The system consists of a reusable diagnostic analyzer (compatible with Elecsys and cobas e immunoassay analyzers, including models like the cobas e 801) paired with disposable test reagents. No additional sterilization is required beyond the manufacturer’s protocols, ensuring ease of use in clinical settings.
Is the Elecsys HCG Test System single-use or reusable?
The analyzer itself is reusable, while the test reagents are disposable. This design minimizes waste and operational costs while maintaining accuracy and sterility for repeated use in laboratory settings.
What storage and handling requirements apply to this system?
Storage and handling follow standard laboratory practices for immunoassay systems. The manufacturer provides specific protocols to ensure proper maintenance, and compliance is verified through FDA-authorized distribution channels. Always adhere to these guidelines to preserve performance and reliability.
What regulatory pathway does the Elecsys HCG Test System follow?
The system is classified under FDA 510(k) clearance (K002148) as a Class II (Moderate Risk) device, with a decision of ‘Substantially Equivalent’ in the Clinical Chemistry advisory committee. This classification reflects its role in quantitative immunoassay testing for hCG detection.
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® HCG STAT - Roche Diagnostics USA, Elecsys® HCG+β - Roche Diagnostics USA, Elecsys HCG+β - Roche
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002148 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA 510(k) K002148 24 fields · synced Oct 1, 2026