510(k) · Cleared
ClearedIVD CAPSULE PSP; abioSCOPE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abionic SA · SCX Immunoassay For Host Biomarkers Of Sepsis
Cleared on Sep 25, 2024 as substantially equivalent to K070310 (Brahms Aktiengesellschaft, 2008) after a 264-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Sep 25, 2024
- Review
- 264 days
- Class
- Class II
- Product code
- SCX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN030002 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backDEN030002 Endotoxin Activity Assay (Eaa) DeviceSpectral Diagnostics, Inc. · 2003
- 2 generations backK040887 B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft · 2005
- 1 generation backK070310 B R a H M S PCT Sensitive Kryptor Test SystemBrahms Aktiengesellschaft · 2008
- This deviceK240041 IVD CAPSULE PSP; abioSCOPEAbionic SA · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN030002 | Endotoxin Activity Assay (Eaa) Device | Spectral Diagnostics, Inc. | 2003 | — |
| −2 | K040887 | B-R-a-H-M-S PCT Lia | Brahms Aktiengesellschaft | 2005 | — |
| −1 | K070310 | B R a H M S PCT Sensitive Kryptor Test System | Brahms Aktiengesellschaft | 2008 | — |
| 0 (this device) | K240041 | IVD CAPSULE PSP; abioSCOPE | Abionic SA | 2024 | — |
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 SCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K070310 | B R a H M S PCT Sensitive Kryptor Test SystemSummary page 6…eference number of platform: P01.00007 Predicate Device Device Name: B.R.A.H.M.S PCT sensitive KRYPTOR® Test System 510(k) Number: K070310 Applicant: B.R.A.H.M.S Aktiengesellschaft Manufacturer: B.R.A.H.M.S GmbH, part of Thermo Fisher Scientific 4.… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All SCX devicesSCX Immunoassay For Host Biomarkers Of Sepsis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SCX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SCX
Too few SCX 510(k)s in any year since 2007 to give a median.
Recalls per year · SCX
No recall names SCX since 2007.
Adverse event reports per year · SCX
No MAUDE report names SCX 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 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP) in human K2-EDTA (arterial and venous) and K3-EDTA (venous) anticoagulated whole blood. The IVD CAPSULE PSP is to be used on the abioSCOPE in vitro diagnostic analyzer. This diagnostic test is used in conjunction with other clinical assessments and laboratory findings to aid…
Read the full statement (133 words)
The IVD CAPSULE PSP is a single-use, rapid in vitro diagnostic immunofluorescence assay for the semi-quantitative determination of the concentration of pancreatic stone protein (PSP) in human K2-EDTA (arterial and venous) and K3-EDTA (venous) anticoagulated whole blood.
The IVD CAPSULE PSP is to be used on the abioSCOPE in vitro diagnostic analyzer. This diagnostic test is used in conjunction with other clinical assessments and laboratory findings to aid in the early detection of sepsis manifesting within the first 3 days after testing. IVD CAPSULE PSP generates PSP values that fall within one of three discrete Interpretation bands based on increasing likelihood of sepsis.
The test is intended for professional use in clinical laboratory settings. It is indicated for use in adult patients at high risk of sepsis presenting to intensive care units (ICUs).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240041: IVD CAPSULE PSP; abioSCOPE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240041
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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