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The Kenota 1 Total IgE is an in vitro test system intended for semi-quantitative measurement of total IgE in human capillary whole blood on the Kenota 1 instrument. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders in conjunction with other clinical findings, and is to be used in allergist/immunologist offices.

Device Description

The Kenota 1 Total IgE test system consists of Kenota 1 Total IgE Cartridge (reagent) and other test components, including Kenota 1 Total IgE External Controls (EC), Kenota 1 (instrument), Kenota 1 Sample Collection Kit (SCK), and Kenota 1 Developing Solution.

AI/ML Overview

Here's an analysis of the provided text to extract acceptance criteria and study details for the Kenota 1 Total IgE device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for semi-quantitative classification are implied by the "Percent in ATE" (Allowable Test Error) within the method comparison study, where ATE means the result is within one category of the comparator. While explicit thresholds for numeric precision are provided, the primary acceptance for classification appears centered around this categorical agreement.

Performance Metric	Acceptance Criteria (Implied/Directly Stated)	Reported Device Performance
Semi-quantitative Agreement (Overall)	Not explicitly stated as a percentage, but shown for each range and overall. The study aims to achieve a high "Percent in ATE" (Allowable Test Error).	96.4% in ATE (344/357), with a 95% CI of (93.9%; 97.9%)
Semi-quantitative Agreement (Low Range)	Implied high percentage in ATE	96.8% in ATE (183/189)
Semi-quantitative Agreement (Middle Range)	Implied high percentage in ATE	96.6% in ATE (84/87)
Semi-quantitative Agreement (High Range)	Implied high percentage in ATE	95.1% in ATE (77/81)
Erroneous Results (LER)	Implied low percentage, ideally 0%	0.0% in LER (0/357), with a 95% CI of (0.0%; 1.1%)
Within-laboratory Precision (Cartridge lots) - %CV	Not explicitly stated, but generally, lower %CV indicates better precision.	Low: 19.6%; Medium: 14.5%; High: 15.9%; Very High: 9.7%
Within-laboratory Precision (Instruments) - %CV	Not explicitly stated, but generally, lower %CV indicates better precision.	Low: 13.6%; Medium: 14.0%; High: 15.3%; Very High: 6.8%
Fingerstick Repeatability - %CV	Not explicitly stated, but generally, lower %CV indicates better repeatability.	5-34 kU/L: 10.6%; 35-100 kU/L: 8.7%; 101-200 kU/L: 9.8%; 201-540 kU/L: 8.4%; 541-900 kU/L: 7.2%; Entire Range: 8.3%
Multi-site Reproducibility (Controls) - %CV	Not explicitly stated, but generally, lower %CV indicates better reproducibility.	Low Control: 12.2%; High Control: 11.6%
Linearity (Categorical Agreement)	100% agreement expected where possible, with some allowance for boundary cases (e.g., <5 and 5-34 boundary).	Achieved high categorical agreement (e.g., 100% agreement for most middle categories, 93.3% for >900 range, 53.3% for <5 and 46.7% for 5-34 at 4 kU/L)
Interference (Bias)	≤±10% difference between test and control sample	No significant interference observed for numerous endogenous and exogenous substances within tested concentrations, except Rheumatoid Factor and Omalizumab.
Detection Limit (LoD & LoQ)	Not explicitly stated as acceptance criteria, but reported values must be robust.	LoD: 5 kU/L; LoQ: 5 kU/L
Accuracy (Recovery Bias)	< ± 10% bias over two blood collector lots	< ± 10% bias across two blood collector lots
Carry-Over	No carry-over between tests	No carry-over observed
Temperature/Humidity (Bias)	< ± 5% bias compared to control conditions	Achieved for several test conditions. Instrument triggers alert for out-of-spec conditions.
Vibration (Bias)	< ± 5% bias compared to control conditions	Achieved.
Tilt (Bias)	< ± 5% bias at ±2 degrees tilt	Achieved. Instrument triggers error for > ±2 degrees tilt.
Lighting (Bias)	< ± 5% bias compared to control conditions	Achieved.
Mechanical Impact (Bias)	< ± 5% bias compared to control conditions	Achieved.
Air Bubbles (Bias)	< ± 5% bias for bubbles up to approximately 4 uL size	Achieved. Instrument has failure alert for larger bubbles.
Cartridge Positions (Bias)	< ± 5% bias compared to average	Achieved.

Study Information

Sample Size Used for the Test Set and Data Provenance:
- Method Comparison Study: 357 samples were used for comparison analysis out of 411 eligible subjects (6 to 80 years).
- Data Provenance: Subjects were "recruited as representative of the intended use population, for patients with eczema or atopy coming in for regular appointments to the allergy specialty care clinics." Data was collected from three CLIA-waived sites in the US (likely prospective, given the recruitment and paired sample collection for the study).
- Fingerstick Repeatability Study: 355 fresh fingerstick whole blood samples.
- Data Provenance: Conducted in three CLIA-waived sites in the U.S. (likely prospective).
- Reference Interval Study: 117 fingerstick samples.
- Data Provenance: Collected from adult (N=95, 22-79 years) and pediatric (N=22, 8 to <22 years) volunteer donors from populations in North Carolina, Virginia, and Minnesota, USA (likely prospective).
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
For the method comparison study, the ground truth was established by a predicate device: "ImmunoCAP Total IgE (K161899)", not by human experts. The predicate device is a quantitative measurement system for total IgE. The text does not mention human experts establishing ground truth for the test set.
Adjudication Method for the Test Set:
Not applicable, as the ground truth was based on a predicate device, not expert consensus requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. The study compares the Kenota 1 device's performance against a predicate device, not human readers with and without AI assistance.
If a Standalone (Algorithm Only) Performance Was Done:
Yes, the entire performance section, including analytical studies (precision, linearity, interference, detection limit) and comparison with the predicate device, represents a standalone performance evaluation of the Kenota 1 Total IgE system. It assesses the device's accuracy and reliability as a direct test system.
Type of Ground Truth Used:
- Method Comparison Study: The ground truth was established by the predicate device, ImmunoCAP Total IgE (K161899). This is a legally marketed quantitative test system for total IgE.
- Analytical Studies (e.g., Precision, Linearity, Detection Limit, Interference): Ground truth was established through spiked samples, pooled samples, or samples with known IgE concentrations measured by validated quantitative laboratory methods or reference materials (e.g., WHO 3rd International Standard Human IgE).
Sample Size for the Training Set:
The document does not provide details on a separate training set for the device itself. The studies described are performance validation studies, usually analogous to a test set for a machine learning model, rather than a training set. For in vitro diagnostic devices like this, calibration (9-level multipoint calibration performed at the manufacturing site) is part of the "training" process. The calibrators used were 0, 2.17, 6.2, 18.6, 37.2, 93, 310, 620, and 930 kU/L.
How the Ground Truth for the Training Set Was Established:
As mentioned above, the device itself is an immunoassay system, not an AI/ML algorithm requiring a distinct "training set" in the conventional sense. Its "training" or calibration involves tying its measurements to a recognized standard.
- Calibration Ground Truth: The working calibrators for the Kenota 1 Total IgE were "traceable to the primary reference material WHO 3rd International Standard Human IgE (11/234)." This international standard serves as the ground truth for establishing the device's measurement scale.

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