# K163260: SeptiCyte LAB

- Pathway: 510(k) (Traditional)
- Applicant: Immunexpress, Inc.
- Decided: Feb 17, 2017 after 88 days
- Product code: PRE (Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN150009 (2016). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR, Brahms GmbH (2016) Summary page 4.

## Most influential descendants
- K203748: SeptiCyte RAPID (2021), 1 descendant of its own
- K241676: TriVerity (2025), 0 descendants of its own

## Indications for use
SeptiCyte™ LAB is a gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood collected in the PAXgene™ Blood RNA Tube. SeptiCyte™ LAB is used in conjunction with clinical assessments and other laboratory findings as an aid to differentiate infection-positive (sepsis) from infection-negative systemic inflammation in patients suspected of sepsis on their first day of ICU admission. The test generates a score (SeptiSCORE™) that falls within one of four discrete Interpretation Bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte™ LAB is intended for in-vitro diagnostic use.

Source page: https://510kreport.com/device/K163260
Methodology: https://510kreport.com/methodology