(31 days)
The MINICAP IMMUNOTYPING kit is designed for the detection and the characterization of monoclonal proteins (immunotyping) in human serum with the MINICAP and the MINICAP FLEX-PIERCING instruments, SEBIA, for capillary electrophoresis. It is used in conjunction with the MINICAP PROTEIN(E) 6 kit, SEBIA, designed for proteins separation into 6 major fractions in alkaline buffer (pH 9.9).
The MINICAP and MINICAP FLEX-PIERCING instruments perform all procedural sequences automatically to obtain a protein profile for qualitative analysis. Each 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 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 suspected monoclonal proteins.
For In Vitro Diagnostic Use.
The MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoresis mobility in an alkaline buffer. The separation occurs according to the electrolyte pH and electro-osmotic flow. In capillary electrophoresis abnormal fractions in serum protein electrophoregrams, primarily those in the beta globulin and gamma globulin zones are always suspected of being monoclonal proteins, paraproteins, monoclonal immunoglobulins) and therefore an indication of a gammopathy. The MINICAP FLEX-PIERCING instrument has 2 capillaries functioning in parallel. A sample dilution is prepared and injected simultaneously by aspiration at the anodic end of the 2 capillaries.
The Immunotyping procedure follows the steps in which the sample is mixed with an ELP solution (reference pattern), specific antisera gamma ( IgG), mu (IgM) heavy chains and free/bound Kappa and Lambda light chains.
A high voltage protein separation is then performed and direct detection of the proteins at 200 nm at the cathodic end of the capillary. The capillaries are then washed and prepared for the next analysis. The superimposition of the antisera patterns with the ELP pattern allows for the visualization of the disappearance and /or the decrease of the monoclonal fraction on the antiserum pattern and to indicate a gammopathy.
The provided text describes a Special 510(k) submission for the MINICAP IMMUNOTYPING device, indicating a modification to allow its use with a new instrument, the MINICAP FLEX-PIERCING. The core of the submission aims to demonstrate that this modification does not change the intended use or fundamental scientific technology of the device and that the performance characteristics remain substantially equivalent to the original cleared device.
Unfortunately, the document does not contain a detailed study report with specific performance data that directly proves the device meets acceptance criteria in a quantitative manner as typically expected for medical device studies. Instead, it states that "Completed detailed sets of data are on file at Sebia manufacturing" and discusses the "results of risk analysis employing acceptance criteria" which were met. Therefore, I cannot provide a table of acceptance criteria with reported device performance or information about sample sizes, ground truth establishment, or expert adjudication as these details are not present in the provided text.
However, I can extract the acceptance criteria as stated for the modified device and explain the general approach taken for the special 510(k) submission based on the available information.
Acceptance Criteria and Study for MINICAP IMMUNOTYPING (using MINICAP FLEX-PIERCING)
The Special 510(k) submission focuses on demonstrating that the MINICAP IMMUNOTYPING procedure, when run on the new MINICAP FLEX-PIERCING instrument, maintains performance equivalent to its use on the predicate MINICAP instrument.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, specific quantitative performance data is not provided in the document to populate such a table. The document states that "Completed detailed sets of data are on file at Sebia manufacturing" and that "The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied."
However, the predetermined acceptance criteria for the modified device are explicitly stated as:
| Acceptance Criteria Claimed | Reported Device Performance |
|---|---|
| 1. The same intended use claim as the unmodified device | The document explicitly states: "The devices have the same intended use, detection and characterization of monoclonal proteins (immunotyping) in human serum using capillary electrophoresis." and "Modifications to the MINICAP IMMUNOTYPING using the MINICAP FLEX-PIERCING instrument do not affect the intended use of the device as describe in the labeling, nor alter the fundamental scientific technology of the device." |
| 2. Substantial equivalency to the predicate device for detection and characterization of monoclonal proteins (immunotyping) in human serum. | The submitted documentation aims to demonstrate this: "Sebia is following the FDA guidance to demonstrate the equivalence to the original reagent and instrument performance by using the Special 510(k) notification process." and "The results indicate that the intended use, qualitative interpretation of the patterns were found substantially equivalent to the original device." Specific data is not presented. |
| 3. Performance characteristics within predetermined criteria. | "The results of risk analysis employing acceptance criteria demonstrate the predetermined performance characteristics were met and the predetermined acceptance criteria were satisfied." Specific performance characteristics and their predetermined ranges are not presented. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided text. The document only mentions "Completed detailed sets of data are on file at Sebia manufacturing."
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The adjudication method for the "electrophoregrams are evaluated visually" is mentioned, implying human interpretation, but details about the experts or their qualifications are absent.
4. Adjudication method for the test set
- The document implies visual evaluation by experts: "The electrophorograms are evaluated visually to detect the presence of specific reactions with suspected monoclonal proteins." However, no specific adjudication method (e.g., 2+1, 3+1) is described for the test set.
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 a device for detecting and characterizing monoclonal proteins using capillary electrophoresis, with visual evaluation of electrophoregrams. It is a modification of an in vitro diagnostic device, not an AI-assisted diagnostic tool for Human Readers. Therefore, an MRMC comparative effectiveness study regarding human readers improving with AI vs without AI assistance is not applicable and not mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device involves instrumental analysis and the 'PHORESIS software' for evaluation, but the final interpretation mentions "electrophoregrams are evaluated visually to detect the presence of specific reactions." This suggests a human-in-the-loop component for qualitative analysis rather than a fully standalone algorithm interpretation. A standalone performance study of the algorithm without human interpretation is not explicitly mentioned or described.
7. The type of ground truth used
- The document describes the device as providing "detection and the characterization of monoclonal proteins (immunotyping) in human serum." The comparison is against the predicate device's performance. The nature of the "ground truth" for the samples used in the underlying studies (e.g., confirmed patient diagnoses, reference lab results, pathology) is not specified.
8. The sample size for the training set
- The document does not detail any "training set." This is a Special 510(k) for an instrument modification to an existing device, focusing on demonstrating substantial equivalence, not a de novo submission for a novel algorithm that would typically involve distinct training and testing sets.
9. How the ground truth for the training set was established
- As no training set is mentioned or described, this information is not applicable/provided.
§ 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).