(264 days)
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 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).
The IVD CAPSULE PSP is a single-use, semi-quantitative immunofluorescence assay used to determine the concentration of the pancreatic stone protein (PSP) in a human whole blood sample. The test kit contains the following components: Capsule, Special pipette (abioPIPETTE), Vial containing a detection reagent (abioMIX), Desiccant bag. The main component is the capsule, a high impact polystyrene plastic cartridge. The capsule allows dispensing the blood-abioMIX solution onto the loading port with a membrane separator. A second membrane drives the sample by capillary force to nanofluidic biosensors containing a read-out area where PSP is captured by specific antibodies and fluorescently detected. The concentration of captured PSP is proportional to the fluorescence generated by the fluorophore conjugated to the detection antibody. The capsule also contains an RFID tag programmed with biosensor configuration and lot-specific information.
The abioSCOPE is a tabletop diagnostic device that measures analytes in biological samples using test-specific capsules (IVD CAPSULE). It is operated through a high-resolution touchscreen. It is composed of a fully automated fluorescence microscope and a tray for the IVD CAPSULE. The abioSCOPE uses a laser to excite molecular complexes inside the biosensors, leading to fluorescence emission. The abioSCOPE then calculates the concentration of the analyte.
The acceptance criteria and the study proving the device meets these criteria are detailed as follows for the IVD CAPSULE PSP device:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided focus on the clinical performance of the device, specifically its ability to classify patients into sepsis risk categories based on PSP concentrations.
| PSP Concentration Range (ng/ml) | Acceptance Criteria (Implied by Likelihood Ratio) | Reported Device Performance (Predictive Value) | Reported Device Performance (Likelihood Ratio) |
|---|---|---|---|
| ≥ 300 | High likelihood of sepsis (Likelihood Ratio > 1.0, specifically indicating strong correlation) | 70.10% | 2.49 (95% CI: 1.83-3.38) |
| 100 - 299 | Moderately increased risk of sepsis (Likelihood Ratio > 1.0, but lower than highest risk category) | 55.30% | 1.32 (95% CI: 1.02-1.70) |
§ 866.3215 Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.
(a)
Identification. A device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis is identified as an in vitro device intended for the detection and qualitative and/or quantitative measurement of one or more non-microbial analytes in human clinical specimens to aid in the assessment of patients with suspected sepsis when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the device's detailed Indications for Use statement describing what the device detects and measures, the results provided to the user, whether the measure is qualitative and/or quantitative, the clinical indications for which the test is to be used, and the specific population(s) for which the device use is intended.
(2) Premarket notification submissions must include detailed documentation of the device description, including (as applicable), all device components, software, ancillary reagents required but not provided, explanation of the device principle and methodology, and for molecular devices include detailed documentation of the primer/probe sequence, design, and rationale for sequence selection.
(3) Premarket notification submissions must include detailed documentation of applicable analytical studies, such as, analytical sensitivity (Limit of Detection, Limit of Blank, and Limit of Quantitation), precision, reproducibility, analytical measuring range, interference, cross-reactivity, and specimen stability.
(4) Premarket notification submissions must include detailed documentation of a prospective clinical study or, if appropriate, results from an equivalent sample set. This detailed documentation must include the following information:
(i) Results must demonstrate adequate device performance relative to a well-accepted comparator.
(ii) Clinical sample results must demonstrate consistency of device output throughout the device measuring range likely to be encountered in the Intended Use population.
(iii) Clinical study documentation must include the original study protocol (including predefined statistical analysis plan), study report documenting support for the Indications for Use(s), and results of all statistical analyses.
(5) Premarket notification submissions must include evaluation of the level of the non-microbial analyte in asymptomatic patients with demographic characteristics (
e.g., age, racial, ethnic, and gender distribution) similar to the Intended Use population.(6) As part of the risk management activities performed under 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(7) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling, and a detailed explanation of the interpretation of the limitations of the samples (
e.g., collected on day of diagnosis) must be included in the device's 21 CFR 809.10(b)(10) compliant labeling.