Not Cleared Direct

DEN220027 - B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN220027 · Brahms GmbH, Part of Thermo Fisher Scientific · Chemistry device
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May 2023
Decision
381d
Days
Class 2
Risk

DEN220027 is an FDA 510(k) submission (not cleared) for the B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System. Classified as Prognostic Test For Development Or Progression Of Preeclampsia (product code QWH), Class II - Special Controls.

Submitted by Brahms GmbH, Part of Thermo Fisher Scientific (Hennigsdorf, DE). The FDA issued a Not Cleared (DENG) decision on May 18, 2023 after a review of 381 days.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1602 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 381 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Brahms GmbH, Part of Thermo Fisher Scientific devices

Submission Details

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 88d · This submission: 381d
Pathway characteristics

Device Classification

Product Code QWH Prognostic Test For Development Or Progression Of Preeclampsia
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.