Cleared Traditional

K203748 - SeptiCyte RAPID (FDA 510(k) Clearance)

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

K203748 · Immunexpress, Inc. · Microbiology device
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Nov 2021
Decision
341d
Days
Class 2
Risk

K203748 is an FDA 510(k) clearance for the SeptiCyte RAPID. Classified as Rt-qpcr Assay For Mrna Transcript Immune Biomarkers (product code PRE), Class II - Special Controls.

Submitted by Immunexpress, Inc. (Seattle, US). The FDA issued a Cleared decision on November 29, 2021 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunexpress, Inc. devices

Submission Details

510(k) Number K203748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2020
Decision Date November 29, 2021
Days to Decision 341 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
239d slower than avg
Panel avg: 102d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PRE Rt-qpcr Assay For Mrna Transcript Immune Biomarkers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition A Quantitative Gene Expression Assay Using Reverse Transcription Polymerase Chain Reaction To Quantify The Relative Expression Levels Of Host Response Genes Isolated From Whole Blood.
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 Microbiology devices follow this clearance model.