(189 days)
UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative measurement of circulating total IgE in human serum or plasma. UniCAP Total IgE assay is to be used with the instrument UniCAP 100. 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 clinical laboratories, as well as, physician office laboratories. Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.
UniCAP is a fully integrated and automated system for the determination of total IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the measurement of total IgE, and Pharmacia Total IgE Control LMH. The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests; samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended. UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced.
Here's an analysis of the provided text regarding the UniCAP Total IgE device, focusing on the acceptance criteria and the study performed:
Acceptance Criteria and Device Performance Study for UniCAP Total IgE
The provided document describes the UniCAP Total IgE Fluoroimmunoassay system, demonstrating its substantial equivalence to the Pharmacia CAP System IgE FEIA. The primary "acceptance criterion" for this 510(k) submission is established through demonstrating strong correlation with an already legally marketed device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | High correlation coefficient (ideally > 0.95-0.98) between the new device and a predicate device for measuring total IgE. | Correlation coefficient of 0.99 between UniCAP and Pharmacia CAP System. |
| Measuring Range | Ability to measure samples across the complete measuring range. | Comparison study included 150 serum samples with concentrations spread over the complete measuring range. |
| Linearity | Linear relationship between measurements from the new device and the predicate device. | Linear regression analysis resulted in the equation y = 24.5 + 1.05x, indicating a strong linear relationship. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 150 serum samples.
- Data Provenance: The document does not explicitly state the country of origin for the samples or whether they were retrospective or prospective. It only mentions they were "serum samples."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes a comparison study against a predicate device, not a study involving expert human interpretation of results to establish ground truth in the traditional sense. The "ground truth" here is effectively established by the predicate device's measurements. Therefore, this section is not applicable in the context of expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. The study compares the device's measurements directly to those of a predicate device, not to human adjudications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This study focuses on the analytical performance of the device itself by comparing it to another device, not on how it aids human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this study is a standalone performance study. The UniCAP Total IgE Fluoroimmunoassay is an automated, in vitro diagnostic device, and the comparison was between its automated measurements and those of a predicate automated system. There is no human-in-the-loop performance described in this comparison study.
7. The Type of Ground Truth Used
The "ground truth" in this context is the quantitative total IgE values obtained from the predicate device, the Pharmacia CAP System IgE FEIA. This represents a reference measurement standard rather than pathology or expert consensus.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of an algorithm or machine learning. This device is an immunoassay system, and its development would typically involve reagent formulation, instrument calibration, and analytical validation rather than machine learning training sets.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the machine learning sense) is mentioned, this section is not applicable. The device's calibration and analytical performance are based on established biochemical and immunological principles, likely validated against known standards and internal controls. The document mentions "A new calibration curve is run once a month, and/or when a new lot number of Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced," which suggests ongoing calibration and quality control rather than a one-time "training set" ground truth.
§ 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).