510(k) · Cleared
ClearedSeptiCyte RAPID
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 Nov 29, 2021 as substantially equivalent to K163260 (Immunexpress, Inc., 2017) after a 341-day review. Its family tree reaches back 2 generations to 2016. 1 later device descends from it.
- Decided
- Nov 29, 2021
- Review
- 341 days
- Class
- Class II
- Product code
- PRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN150009 (2016). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K241676TriVerityInflammatix, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN150009 | B.R.A.H.M.S PCT sensitive KRYPTOR | Brahms GmbH | 2016 | — |
| −1 | K163260 | SeptiCyte LAB | Immunexpress, Inc. | 2017 | — |
| 0 (this device) | K203748 | SeptiCyte RAPID | Immunexpress, Inc. | 2021 | — |
| +1 | K241676 | TriVerity | Inflammatix, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K163260 | SeptiCyte LABSummary page 5…igher likelihood of sepsis. J. Substantial Equivalence Information: 1. Predicate device name(s): SeptiCyte LAB 2. Predicate 510(k) number(s): K163260 Page 7-2 3. Comparison with predicate: Similarities:… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241676 | TriVerity | 2025 | 0 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K241676 (Inflammatix, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2021, 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?
The SeptiCyte ® RAPID test 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. The SeptiCyte ® RAPID test 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…
Read the full statement (118 words)
The SeptiCyte ® RAPID test 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. The SeptiCyte ® RAPID test 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 SeptiCyte ® RAPID 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 ® RAPID is intended for in-vitro diagnostic use on the Biocartis IdyllaTM System.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203748: SeptiCyte RAPID.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203748
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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