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The V8 Nexus Hemoglobin UltraScreen method is designed for the separation of normal hemoglobins (A, A2, and F) in human blood samples, and for the detection of major hemoglobins variants (S and C) by using a capillary zone electrophoresis (CZE) buffer with the V8 instrument. The V8 Nexus Hemoglobin UltraScreen test is indicated for use in patients 2 years of age and older. This test is designed for in-vitro diagnostic use only in conjunction with other laboratory and clinical findings.

The V8 instrument is an automated analyzer which performs a complete hemoglobin profile for quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S and C. The assay is performed on the hemolysate of venous whole blood collected in tubes containing K2EDTA as the anticoagulant. The V8 Nexus Hemoglobin UltraScreen method uses capillary zone electrophoresis (CZE) buffer with the V8 instrument for the separation of normal hemoglobins (A, A2, and F) and detection of major hemoglobin variants (S and C). The V8 AFSA2 Hemo Control is a control material derived from whole blood used as a quantitative and/or qualitative control for the Hemoglobin UltraScreen on the V8 Capillary Electrophoresis (CE) system.

The V8 Nexus Hemoglobin UltraScreen is a medical device for the separation of normal hemoglobins (A, A2, and F) and the detection of major hemoglobin variants (S and C) in human blood samples. The device uses capillary zone electrophoresis (CZE) and is indicated for in-vitro diagnostic use in patients 2 years of age and older.

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1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the precision/reproducibility and comparison studies. For the precision studies, the acceptance criteria would be the measured standard deviation (SD) and coefficient of variation (CV) of the hemoglobin fractions. For comparison studies, the acceptance criteria are generally an R-value close to 1, a slope close to 1, and an intercept close to 0, along with acceptable confidence intervals.

Linearity Acceptance Criteria and Performance:

Limit of Detection (LOD) and Limit of Quantitation (LOQ) Acceptance Criteria and Performance:

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" in this context refers to the clinical samples used for the comparison studies with the predicate device.

• Sample Size for Comparison Studies (Test Set): A total of 439 patient samples were used across three external sites.
  • Hb A quantitation: 320 samples
  • Hb A2 quantitation: 412 samples
  • Hb F quantitation: 175 samples
  • Presumptive Hb S: 143 samples
  • Presumptive Hb C: 33 samples
• Data Provenance: The data comes from three external sites, suggesting a multi-center study setup. The samples were "fresh venous K2-EDTA-anticoagulated whole blood," indicating that these were prospective or recently collected samples for analysis. The country of origin is not explicitly stated, but given the submitter's address (Beaumont, Texas, USA) and FDA submission, it is likely the studies were conducted in the USA.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the "ground truth" for the comparison studies was the results obtained from the predicate device, the Sebia CAPILLARYS Hemoglobin(E) Test (K112491).

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison studies directly compared the performance of the V8 Nexus Hemoglobin UltraScreen to the predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement

No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic assay for analyzing blood samples, not an image-based diagnostic that involves human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are standalone (algorithm only) performance assessments of the V8 Nexus Hemoglobin UltraScreen instrument. These are bench-top studies and comparison studies demonstrating the device's analytical performance on its own, without direct human intervention in the interpretation of the capillary electrophoresis data beyond routine laboratory procedures. The instrument is described as an "automated analyzer."

7. The Type of Ground Truth Used

• For the precision/reproducibility studies, the ground truth was the known composition/percentages of hemoglobin fractions in the controls (AFSA2 and AFSC hemoglobin controls) and patient samples.
• For the comparison studies, the ground truth was the results obtained from the predicate device, the Sebia CAPILLARYS Hemoglobin(E) Test (K112491). This is a common approach for 510(k) submissions, where substantial equivalence to a legally marketed predicate device is demonstrated.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of a machine learning algorithm. This device is a quantitative assay using capillary zone electrophoresis (CZE), a well-established analytical technique. While the term "training" might apply to calibration or method development, a distinct "training set" with established ground truth as would be used for AI/ML validation is not detailed here. The studies focus on analytical validation (precision, linearity, LOD/LOQ, analytical specificity) and comparison to a predicate.

9. How the Ground Truth for the Training Set Was Established

As no specific "training set" for an AI/ML algorithm is described, the method for establishing its ground truth is not applicable in this document. The device's performance is validated against established laboratory standards, controls, and a predicate device.

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