DEN220027 is an FDA 510(k) submission for the B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System. This device is classified as a Prognostic Test For Development Or Progression Of Preeclampsia (Class II - Special Controls, product code QWH).
Submitted by Brahms GmbH, Part of Thermo Fisher Scientific (Hennigsdorf, DE). The FDA issued a Not Cleared (DENG) decision on May 18, 2023.
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 | DEN220027 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | May 02, 2022 |
| Decision Date | May 18, 2023 |
| Days to Decision | 381 days |
| Submission Type | Direct |
| Review Panel | Chemistry (CH) |
| Summary | — |
| 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. |