FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The CAPILLARYS IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS System, SEBIA, for capillary electrophoresis. It is used in conjunction with the CAPILLARYS PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).

The CAPILLARYS performs all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each urine or serum sample is mixed with individual antisera that are specific against gamma (Ig G), alpha (Ig A) and mu (Ig M) heavy chains, and kappa (free and bound) light chains and lambda (free and bound) light chains, respectively.

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

For In Vitro Diagnostic Use.

Device Description

The proteins, separated in silica capillaries, are directly detected by their absorbance at 200 nm.

The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins.

AI/ML Overview

This document is a 510(k) premarket notification approval letter for a medical device called "CAPILLARYS IMMUNOTYPING PN 2100". It establishes substantial equivalence to a predicate device, meaning it doesn't require a new PMA.

Therefore, the document does not contain the level of detail typically found in a clinical study report or a pre-market approval application regarding device performance and acceptance criteria. It primarily focuses on the regulatory approval process based on substantial equivalence.

As a result, I cannot provide the requested information in full detail from the provided text. The information below is what can be inferred or explicitly stated.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance data. An approval based on substantial equivalence implies that the device's performance is comparable to a legally marketed predicate device, but specific metrics are not detailed here.

2. Sample Size Used for the Test Set and the Data Provenance:

This information is not present in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not present in the provided text.

4. Adjudication Method for the Test Set:

This information is not present in the provided text.

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 document describes an "Immunological test system" for detecting and characterizing monoclonal proteins, which appears to be a laboratory diagnostic device, not an AI-assisted imaging or diagnostic tool relevant to MRMC studies comparing human readers with and without AI assistance. Therefore, it is highly unlikely such a study was performed or would be applicable to this device type.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device description states "The electrophoregrams are evaluated visually to detect the presence of specific reactions with the suspect monoclonal proteins." This indicates that human visual evaluation is part of the process, suggesting it's not a purely standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document does not specify the type of ground truth used for validation. For an immunotyping system, it would likely involve comparison to established laboratory methods or reference standards, but this is not detailed.

8. The sample size for the training set:

This information is not present in the provided text.

9. How the ground truth for the training set was established:

This information is not present in the provided text.

Summary of what can be extracted/inferred:

Device Name: CAPILLARYS IMMUNOTYPING, PN 2100
Intended Use: Detection and characterization of monoclonal proteins (immunotyping) in human urine and serum with the CAPILLARYS System, for capillary electrophoresis. Used with CAPILLARYS PROTEIN(E) 6 kit.
Mechanism: Performs automatic procedural sequences to obtain a protein profile. Each sample is mixed with individual antisera specific against Ig G, Ig A, Ig M heavy chains, and kappa and lambda light chains. Proteins are separated in silica capillaries and detected by absorbance at 200 nm.
Evaluation: Electrophoregrams are evaluated visually to detect specific reactions.
Regulatory Basis: Substantial equivalence to a legally marketed predicate device. This implies that the performance is considered comparable, but specific metrics are not provided in this regulatory letter itself.
Human-in-the-loop: Yes, "evaluated visually" indicates human involvement.

Summary

Regulation Number and Section

§ 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).