K241453 is an FDA 510(k) clearance for the Elecsys sFlt-1 and Elecsys PlGF. This device is classified as a Prognostic Test For Development Or Progression Of Preeclampsia (Class II - Special Controls, product code QWH).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 7, 2025, 261 days after receiving the submission on May 22, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1602. 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..
| 510(k) Number | K241453 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 2024 |
| Decision Date | February 07, 2025 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | QWH — Prognostic Test For Development Or Progression Of Preeclampsia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1602 |
| Definition | 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. |