Cleared Traditional

K241453 - Elecsys sFlt-1 and Elecsys PlGF (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241453 · Roche Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Feb 2025
Decision
261d
Days
Class 2
Risk

K241453 is an FDA 510(k) clearance for the Elecsys sFlt-1 and Elecsys PlGF. Classified as Prognostic Test For Development Or Progression Of Preeclampsia (product code QWH), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 7, 2025 after a review of 261 days - an extended review cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K241453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 88d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.