(403 days)
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.
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.
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., 900 range, 53.3% for ±2 degrees tilt. | |
| Lighting (Bias) |
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).