Elecsys CK-MB STAT Immunoassay
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140404 FDA 510(k)
- FDA Product Code
- JHY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1215 FDA 510(k)
- Regulation Number
- 862.1215 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys CK-MB STAT Immunoassay is an in vitro diagnostic device classified as a colorimetric method for creatine kinase isoenzymes (CK-MB). It employs electrochemiluminescence immunoassay (ECLIA) technology to quantitatively measure the MB isoenzyme of creatine kinase in human serum and plasma. This assay is designed to aid in the detection and monitoring of myocardial infarction by identifying cardiac-specific biomarkers. The device leverages two distinct monoclonal antibodies to enhance specificity for human CK-MB, ensuring accurate diagnostic results.
This assay is intended for use on cobas e immunoassay analyzers and is supplied as a ready-to-use reagent system. It is classified as a Class II device under FDA regulations (510(k) clearance, K140404) and is intended for single-use in clinical chemistry laboratories. The device requires proper storage at controlled temperatures and adheres to standard sterility and handling protocols for in vitro diagnostics. No MRI safety considerations apply, as it is not a magnetic resonance-compatible device.
Frequently asked questions
What is the Elecsys CK-MB STAT Immunoassay used for?
The Elecsys CK-MB STAT Immunoassay is designed to quantitatively measure the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma. It aids in detecting and monitoring myocardial infarction by identifying cardiac-specific biomarkers, helping clinicians assess acute cardiac events with greater precision. The assay’s use of two monoclonal antibodies enhances specificity, reducing false positives from skeletal muscle interference.
How is the Elecsys CK-MB STAT Immunoassay supplied and intended for use?
This assay is supplied as a ready-to-use reagent system, eliminating the need for manual preparation or dilution. It is intended exclusively for single-use in clinical chemistry laboratories and operates on Roche’s cobas e immunoassay analyzers. The system is engineered for rapid, high-throughput testing, ensuring timely diagnostic results for acute cardiac care settings.
Is the Elecsys CK-MB STAT Immunoassay sterile and how should it be stored?
Yes, the Elecsys CK-MB STAT Immunoassay adheres to standard sterility protocols for in vitro diagnostics, ensuring safety for single-use applications. It must be stored under controlled temperatures as specified in the manufacturer’s instructions to maintain reagent integrity and accuracy. Improper storage could compromise assay performance or introduce contamination risks.
Can the Elecsys CK-MB STAT Immunoassay be reused or shared between patients?
No, the Elecsys CK-MB STAT Immunoassay is designed for single-use only. Reusing or sharing reagents between patients violates manufacturer guidelines and poses significant risks, including cross-contamination and inaccurate results. Each reagent system is pre-packaged to ensure consistency and sterility for individual patient testing.
Does this assay require any special handling or compatibility considerations?
The assay is compatible only with cobas e immunoassay analyzers and does not require additional handling beyond standard ECLIA protocols. Unlike MRI-compatible devices, this assay has no magnetic resonance-related safety considerations. Proper adherence to storage, handling, and disposal protocols—per manufacturer instructions—is critical to ensure reliable diagnostic performance and compliance with clinical laboratory standards.
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® CK-MB STAT - Roche Diagnostics USA, Elecsys® CK-MB - Roche Diagnostics USA, Elecsys CK-MB STAT - elabdoc-prod.roche.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140404 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K140404 24 fields · synced Oct 1, 2026