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The MINICAP Hb A1c kit is designed for separation and quantification of the HbA1c glycated fraction of hemoglobin in human whole blood, by capillary electrophoresis in alkaline buffer with the MINICAP FLEX-PIERCING instrument. Measurement of hemoglobin A1c is effective in monitoring long-term glycemic control in individuals with diabetes mellitus. Results are provided in IFCC (mmol/mol) and NGSP (%Hb A1c) units.
The MINICAP Hb A1c kit is designed for Professional Use Only.
For In Vitro Diagnostic Use.

The Hb A1c CAPILLARY Controls are designed for the quality control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP HbA1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb A1c CAPILLARY Controls are designed for Professional Use Only.
For In Vitro Diagnostic Use.

The Hb A1c CAPILLARY Calibrators are designed for the calibration and migration control of human glycated hemoglobin A1c quantification with SEBIA capillary electrophoresis procedures using the MINICAP HbA1c kit with the MINICAP FLEX-PIERCING automated instrument.
The Hb A1c CAPILLARY Calibrators are designed for Professional Use Only.
For In Vitro Diagnostic Use.

The MINICAP FLEX-PIERCING instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of HbA1c fraction. The hemoglobins, separated in silica capillaries, are directly detected by their absorbance at 415 nm. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA as anticoagulant.
Quantitative determination of hemoglobin A1c is effective in monitoring middle-term blood glucose control in diabetic individuals.
The MINICAP Hb A1c procedure performed with the MINICAP FLEX-PIERCING instrument has been certified by the National Glycohemoglobin Standardization Program (NGSP).
Electrophoresis is a well established technique routinely used in clinical laboratories for measuring components from body fluids, including HbA1c glycated fraction. The MINICAP FLEX-PIERCING instrument has been developed to provide complete automation of this testing with fast separation and good resolution. In many aspects, the methodology can be considered as an intermediary type of technique between classical zone electrophoresis and liquid chromatography.
The MINICAP FLEX-PIERCING instrument uses the principle of capillary electrophoresis in free solution. With this technique, charged molecules are separated by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also occurs according to the electrolyte pH and electroosmotic flow.
The MINICAP FLEX-PIERCING instrument has silica capillaries functioning in parallel allowing 2 simultaneous analyses for HbA1c quantification from whole blood sample. A sample dilution with hemolysing solution is prepared and injected by aspiration at the anodic end of the capillary. A high voltage protein separation is then performed and direct detection of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the absorbance wave length specific to hemoglobins. Before each run, the capillaries are washed with a wash solution and prepared for the next analvsis with buffer.
Direct detection provides accurate relative quantification of individual hemoglobin Are fraction. In addition, the high resolution of MINICAP Hb A1c procedure allows the quantification of HbA1c, even in the presence of labile HbArc, carbamylated and acetylated hemoglobins, and major hemoglobin variants such as HbS, HbC, HbD, HbE and HbF and common interfering factors such as Triglycerides, Bilirubin, Ascorbic Acid, Urea, Rheumatoid factor and Glybenclamide as outline in the package insert labeling.
By using alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected in the following order, from cathode to anode: A2/C, E, S/D, F, A0, other Hb (including minor Hb A1) and then A1c.

This FDA 510(k) summary (K133344) pertains to the MINICAP Hb A1c kit and associated instruments, calibrators, and controls, which are in vitro diagnostic devices used for the quantification of glycated hemoglobin A1c. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device, not to prove clinical utility through new, independent clinical studies with expert reviewers.

Therefore, many of the requested details regarding acceptance criteria for AI-based systems (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission and the performance data presented. This document focuses on analytical performance and comparison to a predicate device, which falls under the scope of laboratory testing.

Here's an analysis of the provided information, addressing applicable points and noting those that are not relevant:

1. A table of acceptance criteria and the reported device performance.

The acceptance criteria for this type of in vitro diagnostic device are typically established based on analytical performance targets such as precision, linearity, and interference. The submission demonstrates that the new device meets performance characteristics comparable to or better than the predicate device. While explicit "acceptance criteria" for each test are not listed as a separate table, the study results implicitly define the demonstrated performance that was deemed acceptable for clearance by the FDA.

Here's a summary of the analytical performance:

• HbA1c (%) - CV (%) ranges: Within-run reproducibility: 0.0-2.1%; Total reproducibility: 0.0-2.2%
• HbA1c (mmol/mol) - CV (%) ranges: Within-run reproducibility: 0.0-4.0%; Total reproducibility: 0.0-4.0%
  Within same capillary and between capillaries:
• HbA1c (%): Within-run CV% 0.7-1.1%, Within-capillary CV% 0.7-1.5%, Between-run CV% 0.0-0.7%, Between-day CV% 0.0-0.7%, Total CV% 0.8-1.3%
• HbA1c (mmol/mol): Within-run CV% 0.8-1.9%, Within-capillary CV% 0.8-2.8%, Between-run CV% 0.0-1.4%, Between-day CV% 0.0-1.3%, Total CV% 0.8-2.3% |
  | Linearity/Reportable Range | Based on CLSI EP6-A guideline. Strong linear correlation (high r² and r). | HbA1c (%): Y=0.08982x+4.764, r²=0.998, r=0.999. Linearity range: 4.8 - 13.8% HbA1c.
  HbA1c (mmol/mol): Y=0.9855x+28.41, r²=0.999, r=0.999. Linearity range: 29 - 127 mmol/mol HbA1c.
  Linear across 2.5 to 31.1 g/dL total hemoglobin, with HbA1c not affected by total hemoglobin concentration. |
  | Detection Limit | Defined by LoB and LoD. | LoB: 0.3%, LoD: 1.1% |
  | Analytical Specificity (Interference) | Defined as ≤ 0.3% HbA1c difference for common substances, and ±10% difference vs. NGSP reference for hemoglobin variants. | Common Interfering Substances (no significant interference ≤0.3% HbA1c): Triglycerides (3.07 g/dL), Bilirubin (25.8 mg/dL), Ascorbic acid (60 mg/dL), Urea (291 mg/dL), Rheumatoid factor (2178 IU/mL), Glybenclamide (3 mg/dL).
  Carbamylated hemoglobin: ≤ 8.7% (no significant interference).
  Labile HbA1c: ≤ 14.8% (no significant interference).
  Acetylated hemoglobin: ≤ 3.0% (no significant interference).
  Hemoglobin Variants (no significant interference ±10% difference vs. NGSP): HbS (≤ 40.5%), HbE (≤ 24.7%), HbD (≤ 41.0%), HbC (≤ 37.0%), HbF (≤ 19.7%). |
  | Method Comparison (vs. Predicate Device) | Strong correlation (high correlation coefficient) with predicate device. | Internal Study (N=101):
• Percentage (%): Correlation 0.998, y-Intercept 0.165, Slope 0.982
• Concentration (mmol/mol): Correlation 0.998, y-Intercept 1.262, Slope 0.985
  External Study No. 1 (N=126):
• Percentage (%): Correlation 0.998, y-Intercept -0.032, Slope 0.997
• Concentration (mmol/mol): Correlation 0.998, y-Intercept -0.396, Slope 0.996
  External Study No. 2 (N=140):
• Percentage (%): Correlation 0.998, y-Intercept -0.057, Slope 1.019
• Concentration (mmol/mol): Correlation 0.998, y-Intercept -0.316, Slope 1.023 |
  | Matrix Comparison (K2 EDTA vs K3 EDTA) | Strong correlation (high correlation coefficient) between matrix types. | N=41:
• HbA1c (%): Correlation 0.999, y-intercept 0.039, Slope 0.998
• HbA1c (mmol/mol): Correlation 0.999, y-intercept 0.091, Slope 1.001 |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective).

For analytical performance studies:

• Precision/Reproducibility: 8 different blood samples were used in the multi-instrument/lot study. Each sample was analyzed in duplicate across 60 runs over 10 working days. Another study used 8 different blood samples, analyzed in duplicate, across 40 runs over 20 working days for within-capillary/between-capillary reproducibility. The provenance of the samples (e.g., country of origin, retrospective/prospective) is not specified, but given it's an IVD manufacturer in France, it's likely from their local or collaborating clinical sites.
• Linearity: Two blood samples (normal and elevated HbA1c) mixed in different proportions, analyzed in duplicate. Additionally, 3 characteristic blood samples serially diluted and electrophoresed.
• Detection Limit: Five zero samples (blank) and six low HbA1c samples.
• Analytical Specificity (Interference): Whole blood samples with four different HbA1c concentrations for common substances. Four whole blood patient samples for carbamylated, labile, and acetylated hemoglobin studies (each tested in triplicate or triblicate). Hemoglobin variant studies used samples known to contain specific variants (quantities not specified beyond "samples"). Sixteen whole blood samples for HbF interference.
• Method Comparison:
  • Internal Study: 101 whole blood samples.
  • External Study No. 1: 126 whole blood samples.
  • External Study No. 2: 140 whole blood samples.
  • The provenance of these samples (country of origin, retrospective/prospective) is not explicitly stated. However, the term "External study" suggests collaboration with other laboratories. These are typically retrospective samples from clinical labs acquired for method comparison.
• Matrix Comparison: 41 random matched sample pairs (K2 EDTA and K3 EDTA). Data provenance is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience).

This question is not applicable to this type of IVD device submission. Ground truth for HbA1c measurements in this context is established by highly standardized and certified reference methods (NGSP and IFCC), not by subjective expert review of images or clinical data. The predicate device's measurements also serve as a comparative ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set.

This is not applicable. As it's an analytical device measuring a biochemical marker, there is no subjective adjudication process for the results.

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 is not applicable. This submission is for an in vitro diagnostic assay and instrument, not an AI-assisted diagnostic imaging system that uses human readers.

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

The device itself (MINICAP Hb A1c kit with MINICAP FLEX-PIERCING instrument) operates as a standalone analytical system. Its performance metrics (precision, linearity, detection limit, analytical specificity) are its "standalone" performance. There is no human interpretation or "human-in-the-loop" aspect to the quantification of HbA1c % or mmol/mol by the instrument, other than standard laboratory procedures for sample handling and quality control.

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

The "ground truth" or reference for the MINICAP Hb A1c test performance is established against:

• NGSP (National Glycohemoglobin Standardization Program) and IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) requirements/guidelines: The device is standardized according to these globally recognized reference methods for HbA1c measurement. This is the primary "ground truth" for the accuracy of the HbA1c values.
• Predicate Device (CAPILLARYS Hb A1c kit on CAPILLARYS 2 FLEX-PIERCING instrument, K122101): For method comparison studies, the results from the predicate device serve as the comparative standard. Given that the predicate device was also cleared based on NGSP/IFCC standardization, this indirectly links to the same reference standard.

8. The sample size for the training set.

This implies a machine learning or AI context, which is not applicable to this traditional IVD device. The "training" for such a system would be its development and calibration against reference materials and methods, rather than a labeled dataset in the AI sense.

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

As the concept of a "training set" in the AI sense is not applicable, this question is also irrelevant. The device's calibration and validation are based on established laboratory standards and reference materials (NGSP/IFCC traceable calibrators and controls).

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