(407 days)
The Helena V8 Immunodisplacement Kit is designed for the detection and the characterization of monoclonal proteins (immunoglobulin's IgG, IgA, IgM, kappa (bound) and lambda (bound) light chains), in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit designed for serum protein separation into 6 major fractions in alkaline buffer. The electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins. The test results are to be used in conjunction with clinical findings and other laboratory tests.
For In Vitro Diagnostic Use Only.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
Not Found
The provided document is an FDA 510(k) clearance letter for the "V8 Immunodisplacement Kit" and does not contain the detailed study information required to fully answer the request. This document primarily focuses on the regulatory aspects of the device's clearance based on substantial equivalence to a predicate device.
Therefore, I cannot provide all the requested information. However, I can extract what is available and note what is missing.
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not detail specific acceptance criteria or performance metrics from a study.
2. Sample size used for the test set and the data provenance
This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available in the provided document.
4. Adjudication method for the test set
This information is not available in the provided document.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not available in the provided document. The device described (V8 Immunodisplacement Kit) is for in vitro diagnostic use involving capillary electrophoresis and visual evaluation of electrophoretograms. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting imaging or similar data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not available in the provided document. As mentioned, this device appears to be an in vitro diagnostic kit with visual evaluation by a human.
7. The type of ground truth used
This information is not available in the provided document. For this type of device (detection and characterization of monoclonal proteins), ground truth would likely involve established laboratory methods or clinical diagnoses.
8. The sample size for the training set
This information is not available in the provided document. As this is not an AI/machine learning device, the concept of a "training set" in that context may not apply.
9. How the ground truth for the training set was established
This information is not available in the provided document.
Summary of available information from the document:
- Device Name: V8 Immunodisplacement Kit
- Intended Use: Detection and characterization of monoclonal proteins (IgG, IgA, IgM, kappa (bound), and lambda (bound) light chains) in human serum with the Helena V8 Capillary Electrophoresis System. It is used in conjunction with the Helena V8 Serum Protein SPE Kit.
- Evaluation Method: Electrophoretograms of separated proteins mixed with individual specific antisera are evaluated visually to detect the presence of specific reactions with suspect monoclonal proteins.
- Context of Use: Test results are to be used in conjunction with clinical findings and other laboratory tests.
- Regulatory Status: 510(k) clearance based on substantial equivalence to legally marketed predicate devices.
- Classification: Class II, Product Codes: CFF (Immunoglobulins A, G, M, D, and E immunological test systems).
- Prescription Use: Yes.
To obtain the detailed study information regarding acceptance criteria, sample sizes, ground truth establishment, and performance, one would typically need to review the 510(k) submission summary or additional technical documentation provided by Helena Biosciences Europe to the FDA, which is not part of this clearance letter.
§ 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).