(84 days)
The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Not Found
The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device, the Optilite Hevylite IgA Kappa Kit and Optilite Hevylite IgA Lambda Kit. It describes the intended use and regulatory classification, but it does not contain information about:
- Acceptance criteria and reported device performance (in the context of a study demonstrating it meets the criteria)
- Sample sizes for test sets, data provenance, training sets, or how ground truth was established for training sets
- Number/qualifications of experts or adjudication methods for ground truth
- MRMC comparative effectiveness studies or standalone algorithm performance
Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.
The document states the Indications for Use of the device, which are:
- The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser.
- The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser.
- Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Kappa/IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations.
- The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
This indicates the device's role in monitoring IgA multiple myeloma patients, but it does not specify performance metrics or the studies used to validate these claims.
Summary of unavailable information from the given text:
| Question Item | Information Not Available in Document |
|---|---|
| 1. Acceptance Criteria and Reported Performance Table | No acceptance criteria or performance data are presented in this FDA clearance letter. |
| 2. Test Set Sample Size and Data Provenance | Not mentioned. |
| 3. Number and Qualifications of Experts for Test Set Ground Truth | Not mentioned. |
| 4. Adjudication Method for Test Set | Not mentioned. |
| 5. MRMC Comparative Effectiveness Study | No mention of an MRMC study or effect size for human reader improvement with/without AI assistance (device is an IVD kit). |
| 6. Standalone Algorithm Performance Study | Not mentioned (device is an IVD kit, not an AI algorithm in the traditional sense). |
| 7. Type of Ground Truth Used (for any studies) | Not mentioned. |
| 8. Training Set Sample Size | Not mentioned. |
| 9. How Ground Truth for Training Set Established | Not mentioned. |
§ 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).