(86 days)
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.
This document describes the performance of the ELITech Clinical Systems CALCIUM ARSENAZO IVD device. The information provided outlines the analytical performance characteristics and comparison studies rather than clinical or AI-assisted studies typically associated with detailed acceptance criteria of AI/ML-based medical devices.
Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC studies, effect size of AI improvement, standalone AI performance) are not applicable to this type of device submission, which is for an in vitro diagnostic reagent. The "ground truth" here refers to established analytical methods and reference materials, not expert consensus on medical images or clinical outcomes data.
Here's a breakdown of the available information based on your request, focusing on the analytical performance studies conducted for this IVD reagent:
1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:
The document doesn't present explicit "acceptance criteria" in a singular table for all performance characteristics against which the device passed or failed, but rather describes the methodology and results for each analytical performance study. The "acceptance criteria" are generally implied by standard clinical laboratory practices and regulatory expectations for IVD devices (e.g., CLSI guidelines, demonstrating substantial equivalence).
Device Performance Summaries (from the document):
| Performance Characteristic | Acceptance Criteria (Implicit/Standard Practice) | Reported Device Performance (ELITech Clinical Systems CALCIUM ARSENAZO) |
|---|---|---|
| Precision (Serum) | Based on CLSI EP05-A2 protocol (Guideline for acceptable CV%) | Level 1: Within-run CV% 1.1, Total CV% 1.7 (Mean 8.28 mg/dL) |
| Level 2: Within-run CV% 0.5, Total CV% 1.4 (Mean 10.32 mg/dL) | ||
| Level 3: Within-run CV% 0.5, Total CV% 1.0 (Mean 12.96 mg/dL) | ||
| Precision (Urine) | Based on CLSI EP05-A2 protocol (Guideline for acceptable CV%) | Level 1: Within-run CV% 1.3, Total CV% 1.8 (Mean 4.53 mg/dL) |
| Level 2: Within-run CV% 0.5, Total CV% 1.2 (Mean 10.89 mg/dL) | ||
| Level 3: Within-run CV% 0.3, Total CV% 0.8 (Mean 17.51 mg/dL) | ||
| Linearity/Assay Range | Based on CLSI EP06-A protocol (Demonstrate linearity across intended range) | Serum: 5.00 - 15.00 mg/dL, with auto-dilution up to 90.00 mg/dL |
| Urine: 1.50 - 18.00 mg/dL | ||
| On-Board Stability | Deviations from D0 results within acceptance criteria for stability period | 28 days |
| Real-Time Stability | Stable until expiry date | 24 months at 2-8°C |
| Limit of Detection (LoD) | Based on CLSI EP17-A protocol | Serum: 0.04 mg/dL |
| Urine: 0.15 mg/dL | ||
| Limit of Quantification (LoQ) | Based on CLSI EP17-A protocol (e.g., Total Error ≤ 0.32 mg/dL for serum LoQ) | Serum: 5.00 mg/dL |
| Urine: 1.50 mg/dL | ||
| Interference (Serum) | Acceptance criteria: ±10% bias | No significant interference up to specified concentrations for various substances (see table in original text). Minor interference from some monoclonal gammopathies. |
| Interference (Urine) | Acceptance criteria: ±10% bias | No significant interference up to specified concentrations for various substances and pH range (see table in original text). |
| Method Comparison (Serum) | Based on CLSI EP09-A2 protocol (Good correlation with predicate device) | y = 0.949x + 0.41 mg/dL; r = 0.993; r² = 0.986; Sy.x = 0.29 mg/dL (vs. predicate device) |
| Method Comparison (Urine) | Based on CLSI EP09-A2 protocol (Good correlation with predicate device) | y = 0.936x + 0.20 mg/dL; r = 0.995; r² = 0.990; Sy.x = 0.39 mg/dL (vs. predicate device) |
| Matrix Effect (Serum/Plasma) | Based on CLSI EP09-A2 protocol (Good correlation between serum and plasma) | y = 0.976x + 0.26 mg/dL; r = 1.000; r² = 0.993; Sy.x = 0.19 mg/dL (serum vs. lithium heparin plasma) |
2. Sample Size and Data Provenance:
- Precision Studies: 80 measurements for each of 3 levels for both serum and urine (total of 160 measurements per sample type across 20 operating days on 2 instruments).
- Linearity Studies: 11 levels of mixed samples for both serum and urine.
- Interference Studies: For each interferent, 2 sample pools (low and high calcium concentration) were tested, with aliquots spiked at various concentrations (7-9 different concentrations). Each point was measured in triplicate per run.
- Method Comparison (Serum): 106 serum patient samples.
- Method Comparison (Urine): 52 urine patient samples.
- Matrix Effect: 63 paired serum and plasma patient specimens.
Data Provenance: The document generally refers to "patient samples" but does not specify the country of origin. The studies are described as analytical performance evaluations, typically performed retrospectively on collected samples in a controlled laboratory setting. The submitting company is based in France.
3. Number of Experts and Qualifications:
Not applicable for this type of IVD analytical performance study. The ground truth for this device is based on quantitative chemical measurements, established analytical methods (e.g., predicate device, reference methods), and certified reference materials (NIST SRM 956c). Expertise is in analytical chemistry and clinical laboratory science for study design and interpretation, not expert medical opinion on, for example, image interpretation.
4. Adjudication Method:
None applicable. This is an analytical device for quantitative determination, not a diagnostic aid requiring adjudication of clinical findings or interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is an IVD reagent, not an AI/ML-based diagnostic system for human-in-the-loop assistance.
6. Standalone (Algorithm Only) Performance:
This device is a chemical reagent. Its performance is inherent to its chemical reaction and measurement on a specific analyzer (ELITech Clinical Systems Selectra Pro Series Analyzers). Therefore, the concept of "standalone performance" as it applies to an AI algorithm is not applicable. The reported performance metrics (precision, linearity, LoD, LoQ, interference) are its standalone analytical performance.
7. Type of Ground Truth Used:
The ground truth for the analytical performance studies is established by:
- Reference materials: Such as NIST SRM 956c for traceability of calibration.
- Established analytical methods: Comparison against a legally marketed predicate device (ABX Pentra Calcium AS CP) and adherence to CLSI (Clinical and Laboratory Standards Institute) protocols (e.g., EP05-A2 for precision, EP06-A for linearity, EP17-A for detection limits, EP07-A2 for interference, EP09-A2 for method comparison).
- Gravimetric or Volumetric Preparations: For linearity and interference studies, samples are prepared by mixing known concentrations or spiking with known amounts of analytes/interferents.
8. Sample Size for Training Set:
Not applicable. This device is a chemical reagent, not an AI/ML model that requires a "training set." The performance characteristics are determined through standard analytical validation studies.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as above.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.