Cleared Traditional

K232095 - SeptiCyte RAPID (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence.

K232095 · Immunexpress, Inc. · Microbiology device
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Dec 2023
Decision
155d
Days
Class 2
Risk

K232095 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 December 15, 2023 after a review of 155 days - an extended review cycle.

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. Standard predicate reliance. 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 K232095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2023
Decision Date December 15, 2023
Days to Decision 155 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 102d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01905033 Unknown Observational

Molecular Diagnosis and Risk Stratification of Sepsis

7500
Patients (est.)
2
Sites
Condition studied Sepsis
Eligibility All sexes · 18 Years+
Principal investigator Tom van der Poll, Prof.
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Started 2011-01-01 → Primary completion 2018-06-01
Primary outcome
Molecular information about causative pathogens and the host response in patients with sepsis
Secondary outcome
Stratification of septic patients by severity and type of immune response to infection
View full study on ClinicalTrials.gov