510(k) K241453
K241453 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "Elecsys sFlt-1 and Elecsys PlGF". The FDA issued a decision of Substantially Equivalent on February 7, 2025. The device falls under product code QWH (Prognostic Test For Development Or Progression Of Preeclampsia), a Class II device regulated under 21 CFR 862.1602. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2025
- Date Received
- May 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prognostic Test For Development Or Progression Of Preeclampsia
- Device Class
- Class II
- Regulation Number
- 862.1602
- Review Panel
- TX
- Submission Type
A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.