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Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for the separation and measurement of protein fractions in human serum when used with the Bio-Rad BioFocus Capillary Electrophoresis Unit.

The Bio-Rad Serum Proteins by Capillary Electrophoresis is designed for use on the Bio-Rad BioFocus Capillary Electrophoresis Unit. The analytical system, consisting of instrument, CDM software and reagent kit, provides an assay for the separation and percent determination of protein fractions in human serum.

Like the Paragon CZE™ 2000 Clinical Capillary Electrophoresis System, Beckman Instruments, (K953077), the Bio-Rad Serum Proteins by Capillary Electrophoresis "Serum Proteins by CE" (SPCE) utilizes the principle of capillary fraction electrophoresis to separate human serum proteins into five distinct bands. The separation is performed at a pH above the isoelectric point of serum proteins, imparting a net negative charge to each protein that is dependent on the difference between the separation pH and the individual protein isoelectric point. When an electric field is applied across the ends of the capillary, the negatively charged proteins and internal marker migrate toward the anode at a velocity dependent upon the ratio of mass to charge. At this pH, the internal surface of the silica capillary is highly ionized, and the presence of positively charged ions in the separation buffer results in a bulk flow of fluid towards the cathode. This electroosmotic flow (EOF) runs counter to the direction of protein migration and is stronger than the anodic movement of the proteins. As a result, the proteins' net motion is towards the detection zone near the cathodic end of the capillary. Measurement of protein absorbance at 225 nm is then achieved through a transparent section of the silica capillary.

Sample processing consists of a one step dilution of a senum sample with a diluent containing an internal marker. The prepared samples, up to 28, are then placed into the BioFocus for analysis.

A Reference Sample is included as the first sample analyzed in each tray to verify system performance. Proteins are measured, as they exit the cathodic end of the capillary, by direct absorbance of the peotide bond at 225 nm. The Clinical Data Management System (CDM), (K942451), utilizes the time versus signal data along with the internal marker, which is used to convert migration time to electrophoretic mobility, to quantitate the percentage of each of the five protein fractions.

Here's a breakdown of the acceptance criteria and study details for the Bio-Rad Serum Proteins by Capillary Electrophoresis device based on the provided document:

Acceptance Criteria and Device Performance

The general acceptance criteria for this device appear to be tied to demonstrating substantial equivalence to existing predicate devices, specifically the Beckman Paragon SPE kit and the Paragon CZE™ 2000 Clinical Capillary Electrophoresis System. The direct performance metrics evaluated were precision and accuracy (correlation).

Study Details

The Bio-Rad Serum Proteins by Capillary Electrophoresis device was studied to establish its safety and effectiveness by demonstrating substantial equivalence to predicate devices.

1. Sample size used for the test set and the data provenance:

   • Precision Studies: 20 samples each of normal and abnormal control were analyzed for mean area percent.
   • Correlation Study (Accuracy): The document does not explicitly state the sample size for the correlation study beyond "The correlation study... followed NCCLS Document EP9-T."
   • Data Provenance: Not explicitly stated, but given the context of a 510(k) submission to the FDA, it is prospective data collected for the purpose of regulatory approval and is likely from a clinical laboratory setting. The country of origin is not specified, but the submitting company is based in California, USA.

2. 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 "ground truth" for the precision study would be the direct measurements of the samples, and for the correlation study, it would be the results from the predicate device. There is no mention of independent experts establishing ground truth in the traditional sense of diagnostic image/data interpretation.

3. Adjudication method for the test set:

   • Not applicable as this study is evaluating quantitative measurements against a predicate device, rather than subjective interpretations requiring adjudication.

4. 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:

   • No, a MRMC study was not conducted. This device is an automated analytical system, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, the performance described (precision, measuring range, and accuracy) represents the standalone performance of the Bio-Rad Serum Proteins by Capillary Electrophoresis system, which includes the instrument and software for analysis. This is an "algorithm only" type of performance as it's an automated measurement system.

6. The type of ground truth used:

   • For precision, the ground truth is essentially the inherent quantitative measurement of the device itself (reproducibility across multiple runs).
   • For accuracy (correlation), the ground truth was the results obtained from the predicate device, the Beckman Paragon Gel Electrophoresis kit.

7. The sample size for the training set:

   • This document describes performance evaluation studies (test set), not the development or training of an algorithm. Therefore, "training set" information is not applicable and not provided.

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

   • Not applicable, as there is no mention of a training set for an AI algorithm.

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