510(k) · Cleared
ClearedSeptiCyte LAB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunexpress, Inc. · PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Cleared on Feb 17, 2017 as substantially equivalent to DEN150009 (Brahms GmbH, 2016) after an 88-day review. Its family tree reaches back 1 generation to 2016. 2 later devices descend from it.
- Decided
- Feb 17, 2017
- Review
- 88 days
- Class
- Class II
- Product code
- PRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150009 (2016). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN150009 B.R.A.H.M.S PCT sensitive KRYPTORBrahms GmbH · 2016
- This deviceK163260 SeptiCyte LABImmunexpress, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK203748 SeptiCyte RAPIDImmunexpress, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK241676 TriVerityInflammatix, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTOR | Brahms GmbH | 2016 | — |
| 0 (this device) | K163260 | SeptiCyte LAB | Immunexpress, Inc. | 2017 | — |
| +1 | K203748 | SeptiCyte RAPID | Immunexpress, Inc. | 2021 | — |
| +2 | K241676 | TriVerity | Inflammatix, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PRE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PRE device
- #1 K241676 TriVerityscore 9.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTORSummary page 4…eant to aid in the assessment of patients with suspected sepsis (21 CFR 866.3215). Regulatory Class: II 3. PREDICATE DEVICE B·R·A·H·M·S PCT sensitive KRYPTOR® (DEN150009) 4. DEVICE DESCRIPTION SeptiCyte™ LAB is an in vitro diagnostic test to be used when prescribed by a clinician in professi… | 2016 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203748 | SeptiCyte RAPID | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All PRE devicesPRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PRE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PRE
Too few PRE 510(k)s in any year since 2007 to give a median.
Recalls per year · PRE
No recall names PRE since 2007.
Adverse event reports per year · PRE
No MAUDE report names PRE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (102 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163260: SeptiCyte LAB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163260
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026