(236 days)
HYDRAGEL BENCE JONES, MAXI KIT HYDRAGEL BENCE JONES, HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for qualitative detection and identification of Bence Jones proteins (monoclonal free light chains) in urine and serum. The detection of Bence Jones proteins serves as a qualitative aid in the identification of monoclonal gammopathies.
The analysis is generally performed on unconcentrated urine or on diluted serum. All these kits utilize the same composition of alkaline buffered HYDRAGEL BENCE JONES agarose gels and the same procedure which is carried out in two stages:
· electrophoresis of the sample on multi-track agarose gel to separate the individual urinary or serum proteins.
· the separated proteins in the reference track are fixed, the remaining tracks are subjected to respective immunofixation with anti aloha, gamma & mu heavy chain trivalent anti kappa and anti lambda free & bound light chains antisera; anti kappa and anti lambda free light chains antisera. The fixed and immunoprecipitated proteins are then stained with acid violet. The electrophoregrams are evaluated visually. The suspect band (in the reference track) is identified from the positive reaction, or lack of, with the individual antisera.
The HYDRAGEL BENCE JONES kit and MAXI KIT HYDRAGEL BENCE JONES are designed for use with a manual electrophoresis apparatus. The only difference between these two kits is the total number of tests which can be performed with i.e., 10 and 100, respectively. Each agarose gel in the HYDRAGEL BENCE JONES kit and MAXI-KIT HYDRAGEL BENCE JONES is intended to run one sample.
The HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus.
Each agarose gel in the HYDRAGEL 2 BENCE JONES and HYDRAGEL 4 BENCE JONES kits is intended to run two and four samples, respectively.
This document is an FDA 510(k) clearance letter for the HYDRAGEL BENCE JONES Kit. It does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
Specifically, the document states that the device is "substantially equivalent" to predicate devices, which means it met the regulatory requirements for clearance based on comparison to existing devices, rather than necessarily performing a specific study to meet pre-defined acceptance criteria for a novel device.
Here's what is not present in the provided document:
- A table of acceptance criteria and the reported device performance: This document only lists the indications for use and a general description of the test procedure. It doesn't present performance metrics like sensitivity, specificity, accuracy, or any specific numerical acceptance thresholds.
- Sample size used for the test set and the data provenance: There is no mention of a test set, its size, or the origin of any data.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert review or ground truth establishment is provided.
- Adjudication method for the test set: Not applicable as no test set or expert review is described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: This type of study is not mentioned. The device is a diagnostic kit, not an AI-assisted interpretation tool, so MRMC studies are generally not applicable in this context.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a lab kit requiring human interpretation, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described.
- The sample size for the training set: Not applicable as this is not an AI/ML device with a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, this FDA clearance letter confirms the device's substantial equivalence to existing devices for its intended use, but it does not provide the kind of detailed study results and performance metrics that would be present in a clinical trial report or a more extensive submission for a novel device or an AI/ML product.
§ 866.5150 Bence-Jones proteins immunological test system.
(a)
Identification. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).(b)
Classification. Class II (performance standards).