(25 days)
The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.
Here's a breakdown of the acceptance criteria and study detailed in the provided document for the Optilite IgA Kit, organized according to your requested information.
It's important to note that this document is a 510(k) summary for a modification to an existing device (Optilite IgA Kit, K103824). Therefore, the study presented here primarily focuses on confirming that the modified device (with a change from sheep to goat antibody) performs comparably to the predicate device (the original cleared kit) and that the performance characteristics detailed in the original submission still hold true. This is not a study to establish initial performance characteristics, but rather to demonstrate equivalence after a modification.
Acceptance Criteria and Device Performance Study for Optilite IgA Kit (K191985)
This study was conducted to demonstrate that the modified Optilite IgA Kit, with a change in the source of the detection antibody from sheep to goat, maintains comparable performance to the predicate device (Optilite IgA Kit, K103824). The acceptance criteria were primarily based on demonstrating no significant change in performance compared to the previously cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Relative to Predicate Device's Performance Claims) | Reported Device Performance (Modified Kit) | Conclusion |
|---|---|---|---|
| Precision | No change in performance compared to predicate. Data should support existing precision claims in product insert. | Repeatability & Within Lab: Consistent low CV% (1.0-6.3%) across 5 levels. Between Instrument: Low CV% (0.0-2.9%) across 5 levels. Between Lot: Low CV% (0.8-5.2%) across 5 levels. | Meets Criteria: The results do not indicate any change in performance compared to the cleared device (K103824). |
| Linearity/Assay Reportable Range | No change in performance compared to predicate. Data should support existing linearity claims in product insert. | Linear regression equation: y=1.007x + 0.159 g/L with R value of 0.999. | Meets Criteria: Results are comparable to those presented in the original product insert, indicating no change in performance. |
| Kit Stability (Accelerated) | Verified stability in accordance with ISO 23640:2015, with maximum allowable difference of ±15% compared to baseline. Should support 18-month stability claim. | All tested parameters (IR, Controls, Samples 1, 2, 3) passed the accelerated stability criteria, achieving or exceeding the required stability days (e.g., sample 1 achieved 561 equivalent days at 4°C, required 395 days). | Meets Criteria: All parameters passed, verifying the stability claim. |
| Detection Limit (LoD, LoQ, LoB) | No change in performance compared to predicate. Data should support existing claims in product insert. | LoQ validated at 0.02 g/L (within 8% CV acceptance criteria). LoD estimated at 0.007 g/L; LoB estimated at 0.005 g/L. No change observed after antisera change. | Meets Criteria: No change in performance observed, supporting existing LoB, LoD, and LoQ claims. |
| Method Comparison (vs. Predicate) | Bland Altman Mean Bias close to 0%, 95% Limits of Agreement indicating good concordance. Passing Bablok slope close to 1, intercept close to 0. High Correlation Coefficient. No indication of change in performance vs. predicate. | Bland Altman Mean Bias: 2.38%, 95% Limits of Agreement: -10.6% to 15.37%. Passing Bablok: y=1.012x + 0.011 (Slope 95% CI: 1.001 to 1.027, Intercept 95% CI: -0.006 to 0.044). Correlation coefficient: 0.998. | Meets Criteria: Results do not indicate any change in performance compared to the cleared device (K103824). |
| Reference Range Transfer | ≤2 samples falling outside of the limits of the original reference interval from 20 tested samples. | 19 out of 20 samples gave results within the reference interval (0.947 to 4.043 g/L). One sample was at the lower boundary ( |
§ 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).