510(k) K241453

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.