(25 days)
The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are designed for the qualitative detection of oligoclonal bands in the electrophoretic patterns of cerebrospinal fluid (CSF) and confirmation of their immunoglobulin character. The use of anti-IgG antisera permits to prove or disprove the "true" IgG character of oligoclonal banding. Visual, comparative interpretation of immunofixation patterns of IgG in high resolution isoelectric separations of CSF and serum proteins from the same patient allows detection of oligoclonal banding that represents intrathecal synthesis of immunoglobulins.
The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are indicated when certain diseases of the central nervous system (CNS), such as multiple sclerosis, are suspected and the detection of oligoclonal banding and inflammatory processes (intrathecal synthesis of immunoglobulins) can aid to the diagnosis.
The use of enzyme labeled antibodies increases the sensitivity of detection so that the analysis can be generally performed on unconcentrated CSF.
The only difference between the 3 CSF and 6 CSF kits is in the intended number of samples per gel: 3 and 9 CSF/serum sample pairs, respectively.
Not Found
This 510(k) summary does not contain the detailed study information regarding acceptance criteria and performance as it is a premarket notification for substantial equivalence, not a clinical study report. The document states that the device is substantially equivalent to legally marketed predicate devices without providing explicit acceptance criteria or a dedicated study demonstrating performance against specific metrics as would be found in a clinical trial report.
However, based on the provided text, we can infer some general information about the device's intended use and the nature of its performance.
Inferences from the document:
- Device Function: The HYDRAGEL 3 CSF ISOFOCUSING and HYDRAGEL 9 CSF ISOFOCUSING kits are designed for the qualitative detection of oligoclonal bands in cerebrospinal fluid (CSF) and confirmation of their immunoglobulin character for aiding in the diagnosis of certain CNS diseases like multiple sclerosis.
- Performance Claim: The use of enzyme-labeled antibodies increases sensitivity, allowing analysis on unconcentrated CSF.
- Substantial Equivalence: The FDA's review determined substantial equivalence to predicate devices marketed prior to May 28, 1976. This implies that the device's performance is considered comparable to existing, legally marketed devices.
Missing Information (not found in the provided document):
The document does not provide the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Information on a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set.
- How the ground truth for the training set was established.
Conclusion:
This document is a regulatory approval letter based on a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. It typically does not include the detailed performance study results, acceptance criteria, ground truth establishment, or expert involvement that would be found in a comprehensive clinical study report. The FDA concluded that the device is substantially equivalent to existing devices based on the information provided in Sebia's 510(k) submission (K033277).
§ 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).