Cleared Traditional

K240041 - IVD CAPSULE PSP (FDA 510(k) Clearance)

Also includes:
abioSCOPE

Class II Microbiology device cleared through predicate-based substantial equivalence.

K240041 · Abionic SA · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2024
Decision
264d
Days
Class 2
Risk

K240041 is an FDA 510(k) clearance for the IVD CAPSULE PSP. Classified as Immunoassay For Host Biomarkers Of Sepsis (product code SCX), Class II - Special Controls.

Submitted by Abionic SA (Epalinges, CH). The FDA issued a Cleared decision on September 25, 2024 after a review of 264 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3215 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abionic SA devices

Submission Details

510(k) Number K240041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2024
Decision Date September 25, 2024
Days to Decision 264 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 102d · This submission: 264d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SCX Immunoassay For Host Biomarkers Of Sepsis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3215
Definition A Semi-quantitative Immunoassay That Measures The Relative Levels Of Host Response Proteins Isolated From Host Blood Or Similar Specimens.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04105699 Completed Observational Industry-sponsored

Evaluation of Immunoassay Measurements of Pancreatic Stone Protein Performed on abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

A Multicenter, Prospective, Biomarker-result-blinded Observational Study Evaluating Immunoassay Measurements of Pancreatic Stone Protein Performed on Abionic's abioSCOPE® Device With the PSP Assay on ICU Patients at Risk of Sepsis as an Aid in Identifying Sepsis

544
Patients (actual)
5
Sites
Condition studied Sepsis
Eligibility All sexes · 18 Years+
Sponsor Abionic SA (industry)
Started 2019-12-10 → Primary completion 2023-08-23 → Completed 2023-12-28
Primary outcome
Ability of the abioSCOPE PSP assay performed on day 1 of a participant's ICU admission to correctly identify those with sepsis.
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov