Identity
- Trade Name
- ELECSYS ANTI-HCV IMMUNOASSAY & ELECSYS PRECICONTROL ANTI-HCV FOR USE ON MODULAR ANALYTICS E170 IMMUNOSSAY ANALYZER FDA PMA
- Generic Name
- Assay, enzyme linked immunosorbent, hepatitis c virus FDA PMA
Identifiers
- PMA Number
- P090009 FDA PMA
- FDA Product Code
- MZO FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 866.3169 FDA PMA
- Regulation Number
- 866.3169 FDA PMA
- Advisory Committee
- Microbiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Elecsys Anti-HCV Immunoassay is an in vitro diagnostic enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (potassium EDTA, lithium heparin, and sodium heparin). This assay is classified under the nomenclature for microbiology assays and is intended for use on the Modular Analytics E170 Immunoassay Analyzer.
The device is supplied as a reagent kit for use with the Modular Analytics E170 analyzer and is intended for laboratory use. It is not a single-use or reusable device but rather a consumable component of the immunoassay system. The assay employs electrochemiluminescence immunoassay (ECLIA) technology and requires validation through clinical correlation with other laboratory results and patient information. Authorized for use under FDA PMA (P090009), it adheres to regulatory requirements outlined in 866.3169.
Frequently asked questions
What types of samples can the Elecsys Anti-HCV Immunoassay test, and how should they be prepared for analysis?
The Elecsys Anti-HCV Immunoassay is designed to detect total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma collected with potassium EDTA, lithium heparin, or sodium heparin. No additional preparation is required beyond standard serum/plasma collection protocols, as the assay is compatible with these anticoagulants. Results should be interpreted in conjunction with clinical correlation and other laboratory findings.
Is this assay intended for single-use or repeated testing, and how is it supplied?
The Elecsys Anti-HCV Immunoassay is not a single-use device but rather a reagent kit for use with the Modular Analytics E170 Immunoassay Analyzer. It is supplied as a consumable component of the immunoassay system, meaning each kit contains reagents for multiple tests on the analyzer. The kit itself is not reusable; it must be replaced after use to perform additional assays.
What analyzer is required to run the Elecsys Anti-HCV Immunoassay, and does it support any specific testing workflows?
The assay is exclusively intended for use on the Modular Analytics E170 Immunoassay Analyzer by Roche Diagnostics. It employs electrochemiluminescence immunoassay (ECLIA) technology, which requires the analyzer’s automated platform for processing. The workflow includes sample preparation on the analyzer, reagent dispensing, and automated detection of anti-HCV antibodies, with results available for clinical correlation.
How should the reagent kit be stored, and are there any special handling requirements?
While the provided data does not specify storage conditions explicitly, typical immunoassay reagent kits like this one generally require refrigeration (2–8°C) to maintain stability. The kit should be stored in its original packaging, protected from light and moisture, and used within the manufacturer’s recommended expiration date. Always follow Roche Diagnostics’ accompanying instructions for storage and handling to ensure accurate assay performance.
What is the primary clinical use of this assay, and how should results be interpreted?
The Elecsys Anti-HCV Immunoassay is qualitatively detects total antibodies to hepatitis C virus in serum or plasma to aid in the presumptive diagnosis of HCV infection in individuals with symptoms of hepatitis or those at risk. However, the assay does not determine the state of infection or associated disease—results must be interpreted alongside clinical findings and other laboratory tests. It is not a standalone diagnostic tool but part of a broader diagnostic workflow.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P090009 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics Corp.
Sources (1)
- FDA PMA P090009 24 fields · synced Oct 6, 2026