Elecsys sFlt-1 and Elecsys PlGF
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241453 FDA 510(k)
- FDA Product Code
- QWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1602 FDA 510(k)
- Regulation Number
- 862.1602 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Elecsys sFlt-1 and Elecsys PlGF are prognostic tests for the development or progression of preeclampsia. They are used to determine the sFlt-1/PlGF ratio, which is an aid in the diagnosis of preeclampsia in conjunction with other diagnostic and clinical methods. The tests are part of the Clinical Chemistry medical specialty.
The Elecsys sFlt-1 and Elecsys PlGF assays are provided in separate kits and must be used on the same patient sample and the same cobas immunoassay analyzer to calculate the ratio. The device has been authorized with an FDA 510K clearance. The device is classified as a class 2 device with the regulation number 862.1602.
Frequently asked questions
What is the Elecsys sFlt-1 and Elecsys PlGF test used for?
The Elecsys sFlt-1 and Elecsys PlGF tests are used to determine the sFlt-1/PlGF ratio, which aids in the diagnosis of preeclampsia in conjunction with other diagnostic and clinical methods.
How are the Elecsys sFlt-1 and Elecsys PlGF assays supplied?
The Elecsys sFlt-1 and Elecsys PlGF assays are provided in separate kits and must be used on the same patient sample and the same cobas immunoassay analyzer to calculate the ratio.
What is the regulatory status of the Elecsys sFlt-1 and Elecsys PlGF device?
The device has been authorized with an FDA 510K clearance and is classified as a class 2 device with the regulation number 862.1602.
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® sFlt-1/PlGF (Preeclampsia) ratio - Roche Diagnostics USA, Elecsys® sFlt-1 and Elecsys® PlGF - Roche Diagnostics USA, Preeclampsia - Roche Elecsys SFlt-1/PlGF Ratio For Preeclampsia ..., method-sheet-cobas
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241453 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Diagnostics
Sources (1)
- FDA 510(k) K241453 24 fields · synced Sep 25, 2026