Elecsys Troponin T STAT (Short Turnaround Time)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051752 FDA 510(k)
- FDA Product Code
- MMI 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 Troponin T STAT is an immunoassay method for measuring cardiac troponin T, a biomarker used to detect myocardial injury. It employs electrochemiluminescence immunoassay (ECLIA) technology to quantify troponin T levels in blood samples, aiding in the diagnosis of acute coronary syndromes and cardiac conditions.
This device is designed for use on cobas e immunoassay analyzers and is intended for in vitro diagnostic use. It is supplied as a single-use reagent system and requires no special storage conditions beyond standard laboratory practices. The Elecsys Troponin T STAT holds FDA 510(k) clearance under the Special 510(k) pathway, classified as a Class II device under regulation 862.1215.
Frequently asked questions
What clinical conditions is the Roche Elecsys Troponin T STAT immunoassay primarily used to diagnose or monitor?
The Roche Elecsys Troponin T STAT is designed to measure cardiac troponin T levels in blood samples, which helps detect myocardial injury. This biomarker is critical for diagnosing acute coronary syndromes and other cardiac conditions, such as heart attacks or unstable angina, by identifying elevated troponin T concentrations linked to heart muscle damage.
How is the Elecsys Troponin T STAT reagent system supplied, and is it reusable?
The Elecsys Troponin T STAT is supplied as a single-use reagent system, meaning each kit is intended for one test cycle only. This design ensures consistency and reduces the risk of contamination or cross-sample carryover, which is important for accurate cardiac troponin T measurements.
What type of analyzer is required to run the Elecsys Troponin T STAT test, and does it have any special storage requirements?
The Elecsys Troponin T STAT is specifically designed for use on cobas e immunoassay analyzers from Roche Diagnostics. No special storage conditions are required beyond standard laboratory practices, such as protecting it from extreme temperatures or direct light, which is typical for most immunoassay reagents.
What regulatory pathway was used for FDA clearance of this device, and what class does it fall under?
The Elecsys Troponin T STAT received FDA 510(k) clearance under the Special 510(k) pathway, classified as a Class II medical device under regulation 862.1215. This classification reflects its role as an immunoassay method for measuring cardiac troponin T, which is considered moderately high risk due to its diagnostic implications for serious cardiac conditions.
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® Troponin T hs STAT - Roche Diagnostics USA, Elecsys® Troponin T hs STAT - Roche Diagnostics USA, Elecsys Troponin T hs Gen 6 - 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 | K051752 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K051752 24 fields · synced Sep 19, 2026