IVD CAPSULE PSP - IVD CAPSULE PSP
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Abionic SA
Identifiers
- 510(k) Number
- K240041 FDA 510(k)
- FDA Product Code
- SCX FDA 510(k)
- Models / Variants
- IVD CAPSULE PSP FDA 510(k)EUDAMED
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3215 FDA 510(k)
- Regulation Number
- 866.3215 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The IVD Capsule PSP is an immunoassay device for host biomarkers of sepsis, classified under the nomenclature for in vitro diagnostic tests. It quantifies sepsis-related biomarkers in whole blood to support early detection and monitoring of sepsis progression, leveraging nanofluidic technology for rapid, lab-quality results.
This single-use, near-patient device requires a 50 µL sample of whole blood and delivers results within five minutes. Supplied as a sterile, disposable capsule for use on the abioSCOPE platform, it is regulated under FDA 510(k) clearance (K240041) and IVDR compliance. The device is intended for Emergency and Critical Care settings, with no MRI safety considerations specified.
Frequently asked questions
What types of clinical settings is the IVD Capsule PSP designed for, and why is this important for my workflow?
The IVD Capsule PSP is specifically designed for Emergency and Critical Care settings, where rapid sepsis detection is critical. This makes it ideal for environments like ERs, ICUs, or trauma centers where delays in diagnosis can significantly impact patient outcomes. Its near-patient use and five-minute turnaround time allow clinicians to monitor sepsis progression *at the point of care*, reducing the need for lab-dependent delays and enabling faster intervention decisions.
How is the IVD Capsule PSP supplied, and what does this mean for my inventory management?
The device is supplied as a single-use, sterile, disposable capsule—no assembly or preparation is required beyond loading it onto the abioSCOPE platform. This eliminates the need for sterilization or reprocessing, simplifying inventory management and reducing waste compared to reusable systems. Each capsule is designed for one test, ensuring consistent performance without cross-contamination risks, which is particularly important in high-turnover emergency settings.
What sample volume is required, and how does this compare to traditional sepsis testing methods?
The IVD Capsule PSP requires only 50 µL of whole blood, which is significantly less than many traditional sepsis biomarker assays (often requiring 1–2 mL or more). This minimal sample size is advantageous in critical care, where blood draws are limited due to patient instability or coagulopathy. The small volume also reduces patient discomfort and the risk of iatrogenic anemia, making it practical for frequent monitoring.
Is the device compatible with any other platforms, or is the abioSCOPE platform a requirement?
The IVD Capsule PSP is exclusively designed for use with the abioSCOPE platform—it is not a standalone device. This integration ensures seamless operation, automated sample handling, and rapid result delivery within five minutes. While the capsule itself is disposable, the abioSCOPE platform is likely reusable (as implied by its role as a reader/instrument), so your workflow would need to account for platform maintenance and calibration alongside capsule inventory.
How does the nanofluidic technology in this device impact the accuracy and reliability of sepsis biomarker detection compared to conventional methods?
The device leverages nanofluidic technology to deliver lab-quality results in a near-patient format, which traditionally requires centralized lab infrastructure. This technology enables precise quantification of sepsis-related biomarkers with high sensitivity and specificity, reducing false positives/negatives that can occur with less sophisticated point-of-care tests. The rapid turnaround (five minutes) also aligns with clinical needs for immediate triage, though validation studies would confirm its performance against gold-standard lab methods in your specific patient populations.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Home | Abionic, PSP / abioSCOPE® Prime Biosciences, The abioSCOPE® | Abionic, PDF 143696-abioscope-ivd-test-kit-psp-abionic-user-manual
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K240041 | Class II | Active |
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Manufacturer
- Manufacturer
- Abionic SA
Sources (2)
- FDA 510(k) K240041 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026