FDA Product Code QWH: Prognostic Test For Development Or Progression Of Preeclampsia
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.
Leading manufacturers include Roche Diagnostics.
FDA 510(k) Cleared Prognostic Test For Development Or Progression Of Preeclampsia Devices (Product Code QWH)
About Product Code QWH - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QWH since 2023, with 1 receiving FDA clearance (average review time: 321 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QWH have taken an average of 261 days to reach a decision - down from 381 days historically, suggesting improved FDA processing for this classification.
QWH devices are reviewed by the Chemistry panel. Browse all Chemistry devices →