Modification To Vitros Immunodiagnostic Products Troponin I Reagent Pack/ Calib…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020662 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 Vitros Troponin I Reagent Pack and Calibrators is an immunoassay method designed for the quantitative measurement of Troponin I, a cardiac biomarker. Troponin I is used as an indicator of myocardial injury, aiding in the diagnosis of acute coronary syndromes and other cardiac conditions. This device operates within the Vitros Immunodiagnostic System, leveraging immunoassay technology to detect and quantify Troponin I concentrations in heparin plasma samples.
This modification to the existing Vitros Troponin I Reagent Pack and Calibrators is intended for use in clinical chemistry laboratories. Supplied as a reagent pack and calibrators, the device is classified as a Class II medical device under FDA regulation 862.1215. The product is intended for single-use and requires proper storage and handling as specified by the manufacturer. The modification received FDA 510(k) clearance (K020662) under the Traditional 510(k) Review process, with a decision of Substantially Equivalent (SESE) by the Clinical Chemistry (CH) Advisory Committee.
Frequently asked questions
What is the Vitros Troponin I Reagent Pack used for?
The Vitros Troponin I Reagent Pack is designed for the quantitative measurement of Troponin I, a cardiac biomarker. Troponin I serves as an indicator of myocardial injury, helping clinicians diagnose acute coronary syndromes and other cardiac conditions. It operates within the Vitros Immunodiagnostic System, using immunoassay technology to detect and quantify Troponin I concentrations in heparin plasma samples.
How is the Vitros Troponin I Reagent Pack supplied?
This device is supplied as a reagent pack combined with calibrators. It is intended for single-use only, meaning each pack is designed for one-time use in clinical chemistry laboratories. Proper storage and handling, as specified by Ortho-Clinical Diagnostics, are essential to maintain the product’s integrity and performance.
Is the Vitros Troponin I Reagent Pack sterile?
The device data does not explicitly state whether the reagent pack or calibrators are sterile. However, as a medical device intended for clinical use, it is reasonable to assume it follows standard practices for sterility in immunoassay products. For precise details, refer to the manufacturer’s instructions for use or contact Ortho-Clinical Diagnostics directly.
What regulatory pathway was followed for this modification?
The modification to the Vitros Troponin I Reagent Pack and Calibrators received FDA 510(k) clearance under the Traditional 510(k) Review process. The decision was classified as Substantially Equivalent (SESE) by the Clinical Chemistry (CH) Advisory Committee. This means the device was determined to be as safe and effective as a legally marketed predicate device.
Where can this device be used?
The Vitros Troponin I Reagent Pack and Calibrators are intended exclusively for use in clinical chemistry laboratories. They are compatible with the Vitros Immunodiagnostic System, which is designed for diagnostic testing in controlled laboratory environments. The device is not intended for home use or point-of-care testing outside of a clinical setting.
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: Modification to Vitros Immunodiagnostic Products Troponin I Reagent ..., Modification to Vitros Immundodiagnostic Products Troponin I Reagent ..., MODIFICATION TO VITROS IMMUNODIAGNOSTIC PRODUCTS… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020662 | Class II | Active |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA 510(k) K020662 24 fields · synced Oct 1, 2026