Cleared Traditional

K163260 - SeptiCyte LAB (FDA 510(k) Clearance)

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

K163260 · Immunexpress, Inc. · Microbiology device
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Feb 2017
Decision
88d
Days
Class 2
Risk

K163260 is an FDA 510(k) clearance for the SeptiCyte LAB. 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 February 17, 2017 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immunexpress, Inc. devices

Submission Details

510(k) Number K163260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2016
Decision Date February 17, 2017
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
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.