(128 days)
Hevylite Human IgG Kappa is a quantitative in vitro assay performed on the Siemens BN II nephelometer for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Kappa is used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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.
Hevylite Human IgG Lambda is a quantitative in vitro assay performed on the Siemens BN II nephelometer of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgG Lambda is used alongside Hevylite Human IgG Kappa / IgG Lambda ratio. The Hevylite Human IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma 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.
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This FDA 510(k) clearance letter pertains to the Hevylite™ Human IgG Kappa Kit and Hevylite™ Human IgG Lambda Kit for use on Siemens BN™ II Systems. It's important to note that this document is a regulatory approval and does not contain the specifics of a study proving the device meets acceptance criteria in the format you requested for AI/ML devices.
The information typically found in a clinical study report for an AI/ML device, such as sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, is not present in this regulatory correspondence for an in vitro diagnostic test system.
However, I can extract information related to the device and its intended use, and general aspects of regulatory review for in vitro diagnostic kits.
General Information on this Device:
- Device Name: Hevylite™ Human IgG Kappa Kit and Hevylite™ Human IgG Lambda Kit
- System Used On: Siemens BN™ II nephelometer
- Regulation Number: 21 CFR 866.5510
- Regulation Name: Immunoglobulins A, G, M, D, and E Immunological Test System
- Regulatory Class: II
- Product Code: PCN, PCO
- Indications for Use:
- Hevylite Human IgG Kappa: Quantitative in vitro assay for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum. Used alongside Hevylite Human IgG Lambda to calculate the IgG Kappa / IgG Lambda ratio. The ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations.
- Hevylite Human IgG Lambda: Quantitative in vitro assay for the measurement of IgG Lambda (IgG heavy chain and Lambda light chain intact immunoglobulin) in serum. Used alongside Hevylite Human IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The ratio can be used when monitoring previously diagnosed IgG multiple myeloma and is used in conjunction with other laboratory tests and clinical evaluations.
- Important Caveat: "The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments." This indicates the device is an aid in diagnosis/monitoring, not a standalone definitive test.
Why the requested information is not in this document:
This is a 510(k) clearance letter. For in vitro diagnostic devices like these, the "acceptance criteria" and "study proving the device meets acceptance criteria" are typically detailed in the technical documentation submitted by the manufacturer to the FDA. This documentation would include:
- Analytical Performance Studies: Demonstrating accuracy, precision, linearity, limit of detection, limit of quantitation, interference, calibration, etc. These would have specific acceptance criteria (e.g., %CV for precision, % recovery for accuracy) and study designs (e.g., number of replicates, number of samples).
- Clinical Performance Studies: Demonstrating how well the device performs in a clinical setting, often comparing its results to established methods or clinical outcomes. These studies would involve patient samples and typically assess aspects like sensitivity, specificity, positive predictive value, negative predictive value, and agreement with predicate devices or clinical endpoints.
The FDA reviews this submitted data and, if it finds the device "substantially equivalent" to a predicate device, issues this clearance letter. The letter itself is primarily the outcome of that review, not the detailed study results.
Therefore, the table and detailed information you requested about acceptance criteria and study particulars for an AI/ML device cannot be extracted directly from this specific document because:
- It is not an AI/ML device. It's an in vitro diagnostic immunoassay kit.
- This document is a clearance letter, not a study report. The detailed study data reviewed by the FDA is proprietary and part of the manufacturer's 510(k) submission, not typically published in the clearance letter.
To provide the information you're looking for, one would need access to the complete 510(k) submission document, which is not publicly available in detail, or peer-reviewed publications by the manufacturer discussing the performance studies.
§ 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).