Cleared Traditional

Elecsys sFlt-1 and Elecsys PlGF

K241453 · Roche Diagnostics · Chemistry
Feb 2025
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K241453 is an FDA 510(k) clearance for the Elecsys sFlt-1 and Elecsys PlGF, a Prognostic Test For Development Or Progression Of Preeclampsia (Class II — Special Controls, product code QWH), submitted by Roche Diagnostics (Indianapolos, 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 review panel. Regulated under 21 CFR 862.1602.

Submission Details

510(k) Number K241453 FDA.gov
FDA Decision Cleared 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

Device Classification

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.