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The Lucica® Glycated Albumin-L is intended to be used for the quantitative measurement of glycated albumin in human serum on compatible clinical chemistry analyzers. The measurement of glycated albumin is useful for the intermediate term (preceding 2-3 weeks) monitoring of glycemic control in patients with diabetes. For in vitro diagnostic use only.

Lucica® Glycated Albumin-L contains two glycated albumin reagents and two albumin reagents. The kit employs liquid reagents that require no preparation.

The document describes the analytical performance and clinical utility of the Lucica® Glycated Albumin-L device, which is an in vitro diagnostic test for measuring glycated albumin in human serum. As such, the acceptance criteria and study design are focused on the analytical accuracy and precision of the diagnostic assay rather than a complex AI-driven medical device that uses machine learning to classify or detect.

Based on the provided text, here's a breakdown of the information requested, with "N/A" where the information is not applicable to this type of device or study:

Acceptance Criteria and Device Performance for Lucica® Glycated Albumin-L

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a "table of acceptance criteria" in the format one might expect for an AI/ML device (e.g., target specificity, sensitivity, etc.). Instead, it details various analytical performance studies with implicit criteria for acceptable performance (e.g., %CV limits for precision, linearity range, interference limits).

Here's a summary of the performance data, with implied acceptance criteria based on standard laboratory assay validation:

                                                                                                                                                                                                                                                                                                                                                                           |

| | Multisite Reproducibility: %CV ≤ 1.6% | Multisite Reproducibility: Max %CV = 1.6% (for Pool serum 1) |
| Linearity | Linear across the range from lowest to highest GA value serum | Supported linearity across the range of 173 to 979 mmol/mol. |
| Traceability | Traceable to established reference materials | Traceable to "Committee on Diabetes Mellitus Indices of the Japan Society of Clinical Chemistry-recommended reference measurement procedure and reference materials for glycated albumin determination" and Secondary Calibrators (Glycated Albumin Certified Material, JCCRM 611-1, M, H, HH). |
| Stability | Reagent, Calibrator, Control stability within specified limits | Reagent Shelf-life: 12 months (2-8 °C). Open Reagent: 1 month (Modular P reagent cabinet).
Calibrator Shelf-life: 12 months (≤ 8 °C). Calibrator In-use: 2 weeks (≤ 8 °C).
Control Shelf-life: 12 months (≤ 8 °C). Control In-use: 1 month (≤ 8 °C). |
| Limit of Detection (LoD) | Defined and quantifiable | GA LoB: 6.9 µmol/L; GA LoD: 7.9 µmol/L; GA LoQ: 9.7 µmol/L.
Albumin LoB: 3.8 µmol/L; Albumin LoD: 7.0 µmol/L; Albumin LoQ: 21.8 µmol/L. |
| Interference Studies | Bias due to interferents ≤ 10% | No significant interference (% bias ≤ 10%) for:

• Unconjugated bilirubin (20.0 mg/dL)
• Conjugated bilirubin (20.0 mg/dL)
• Hemoglobin (288 mg/dL)
• Glucose (1,000 mg/dL)
• Ascorbic Acid (100 mg/dL)
• Triglycerides (1,516 mg/dL)
• Uric Acid (23.5 mg/dL)
  Noted interference: Hemoglobin at 384 mg/dL decreased GA by 12.9% (at 240 mmol/mol) and 9.9% (at 467 mmol/mol).
  Triglycerides at 2,004 mg/dL decreased GA by 11.6% (at 232 mmol/mol) and 2.6% (at 467 mmol/mol). |
  | Reference Range | Established for healthy non-diabetic subjects | 183 and 259 mmol/mol for 262 healthy non-diabetic subjects in the US. |

2. Sample Size for Test Set and Data Provenance

• Test Sample Size:

  • Precision (Single Site): 5 serum sample pools, each assayed twice per run, two runs per day, for 20 testing days (N=80 results for each pool).
  • Precision (Multisite): 3 serum sample pools, tested at 3 different laboratories. Each sample assayed five replicates per run, one run per day, for five testing days (N=25 results per site per pool, total 75 results per pool across sites).
  • Linearity: Lowest and highest GA value serum sample pools mixed in varying ratios. Samples analyzed in triplicate in one run. (Specific number of mixed samples not detailed).
  • LoB, LoD, LoQ: Performed according to CLSI Guideline EP17-A2. (Specific number of samples not detailed, but standard for these studies).
  • Interference: Two base serums (Normal pool serum and DM serum) with potential interfering substances spiked in. Six total different concentration levels prepared. (Specific number of samples not detailed, but standard for these studies).
  • Reference Range Study: 262 healthy non-diabetic subjects.

• Data Provenance: The reference range study was conducted on subjects in the US. Other analytical performance studies (precision, linearity, etc.) are laboratory-based and do not specify patient origin beyond "serum samples" or "serum sample pools." The studies are retrospective in the sense that they are validations of an already developed assay, not prospective patient trials for clinical outcomes.

3. Number of Experts and Qualifications for Ground Truth

• N/A. For this type of in vitro diagnostic device (a quantitative assay), "ground truth" is established by reference methods or gravimetric/analytical standards (e.g., certified reference materials for traceability, known concentrations for linearity and spiked interference studies). There are no human experts classifying images or clinical findings that require consensus.

4. Adjudication Method for Test Set

• N/A. As mentioned above, this device performs a quantitative measurement, not a classification or diagnosis that would require expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• N/A. This is a laboratory-based quantitative assay, not an imaging device or an AI system that assists human readers. Therefore, an MRMC study is not applicable.

6. Standalone (Algorithm Only) Performance

• Yes. All the performance data (precision, linearity, LoD, interference, etc.) represent the standalone performance of the Lucica® Glycated Albumin-L assay itself, without human-in-the-loop assistance for interpretation. The device outputs a quantitative measurement of glycated albumin.

7. Type of Ground Truth Used

• The ground truth for the analytical performance studies (precision, linearity, LOQ/LOD, interference) is based on analytical standards, reference materials, known spiked concentrations, and statistical methods (e.g., CLSI guidelines).
• For the reference range study, the ground truth is established by the clinical status of the subjects (healthy non-diabetic), confirmed by their diagnostic status.
• The "Outcomes" section refers to peer-reviewed scientific literature demonstrating the clinical utility of glycated albumin as a biomarker for glycemic control and its association with micro/macrovascular complications. This is external evidence supporting the medical relevance of the analyte, not ground truth specific to this device's performance validation.

8. Sample Size for Training Set

• N/A. This is a quantitative chemical assay, not an AI/ML model that requires a "training set" in the computational sense. The reagents and assay parameters are developed and optimized through traditional chemistry and engineering processes.

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

• N/A. (See point 8). The "training" for such a device involves chemical formulation, assay development, and calibration, which rely on established laboratory practices, chemical principles, and reference materials.

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