(71 days)
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.
The Optilite IgM CSF Kit comprises the following reagents:
Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 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.
The provided text describes the 510(k) submission for the Optilite IgM CSF Kit, an in vitro diagnostic device, not an AI/ML-based device. Therefore, the questions related to AI/ML specific criteria, such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details, are not applicable to this submission.
The acceptance criteria and device performance evaluation for this diagnostic kit are centered on analytical performance characteristics, which are standard for laboratory assays.
Here's a breakdown of the applicable information from the provided text:
1. Table of acceptance criteria and the reported device performance:
| Performance Characteristic | Acceptance Criteria (from CLSI Guidelines and Internal Standards) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Total Precision (%CV) |
§ 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).