(88 days)
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. 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).
ELITech Clinical Systems ALBUMIN is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma on ELITech Clinical Systems Selectra analyzers. It is not intended for use in Point of Care settings. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: MES buffer (pH 6.50), Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydronaphtalene-3,6-disulphonic acid].
The device for this submission is available as kit only. It consists of 1 reagent "R". Reagent R contains: Succinate buffer (pH 4.20), Bromocresol green, Brij 35.
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
The provided text describes several in-vitro diagnostic devices (reagents, calibrators, and controls) and their performance characteristics. However, it does not contain information about studies involving AI, human readers, or image analysis. The data provided is for traditional laboratory assays, comparing a new device to a predicate device.
Therefore, many of the requested elements for describing an AI device's acceptance criteria and study are not applicable or cannot be extracted from this document, such as:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not specified for clinical samples in the context of an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts - Not applicable for chemical assays.
- Adjudication method - Not applicable for chemical assays.
- 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 AI component described.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - No AI component described.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not explicitly stated in terms of expert consensus or pathology for clinical samples, but implied to be analytical results from established methods.
- The sample size for the training set - No AI component described, so no training set discussed.
- How the ground truth for the training set was established - No AI component described.
Below is an attempt to address the request based only on the information available in the provided text, primarily focusing on the "ELITech Clinical Systems CALCIUM ARSENAZO" reagent as it is the first device detailed.
Acceptance Criteria and Device Performance Study for ELITech Clinical Systems CALCIUM ARSENAZO
The provided document describes the performance characteristics of the ELITech Clinical Systems CALCIUM ARSENAZO reagent, a quantitative in vitro diagnostic device for total calcium in human serum and plasma. The study presented is a comparison to a legally marketed predicate device, Stanbio Calcium LiquiColor® (Arsenazo III) (K921625), to demonstrate substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to the predicate device, where the new device's performance metrics are expected to be comparable or better. The table below summarizes the reported performance of the ELITech Clinical Systems CALCIUM ARSENAZO. Specific numerical acceptance criteria (e.g., "must be ≥X") are not explicitly stated as separate targets, but rather demonstrated through direct comparison to the predicate's known performance or through established analytical performance ranges.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (ELITech Clinical Systems CALCIUM ARSENAZO) |
|---|---|---|
| Intended Use | Quantitative in vitro diagnostic determination of total calcium in human serum and plasma. | Same as predicate. |
| Measuring Range | Comparable to 0 to 15 mg/dL | 5.0 - 15.0 mg/dL |
| Limit of Detection (LoD) | Not explicitly stated for predicate in summary, but assumed to be very low. | 0.36 mg/dL |
| Limit of Quantification (LoQ) | Not explicitly stated for predicate. | 5.00 mg/dL |
| Precision (Within Run) | Comparable to CV=1.3% (Level 11.0 mg/dL) and CV=0.9% (Level 14.3 mg/dL) | Level 8.75 mg/dL CV= 1.3% |
| Level 9.68 mg/dL CV= 0.9% | ||
| Level 11.97 mg/dL CV=0.7% | ||
| Precision (Total/Run-to-run) | Comparable to CV=1.1% (Level 11.2 mg/dL) and CV=1.3% (Level 14.3 mg/dL) | Level 8.75 mg/dL CV= 1.9% |
| Level 9.68 mg/dL CV= 1.9% | ||
| Level 11.97 mg/dL CV= 1.9% | ||
| Method Comparison | Linear regression parameters and correlation coefficient (r) comparable to y=0.99x+0.10 mg/dL, r=0.989. | y= 1.008x - 0 mg/dL |
| r= 0.996 (range: 4.90 to 14.37 mg/dL) | ||
| Interference | Minimal interference from common substances (Hemoglobin, Bilirubin, Lipemia). | Hemoglobin: No significant interference up to 500 mg/dL. |
| Triglycerides: No significant interference up to 1119 mg/dL. A positive bias observed above 1119 mg/dL. | ||
| Unconjugated bilirubin: No significant interference up to 30.0 mg/dL. | ||
| Conjugated bilirubin: No significant interference up to 29.5 mg/dL. | ||
| Magnesium: No significant interference up to 10.91 mg/dL. | ||
| Ascorbic acid: No significant interference up to 20 mg/dL. | ||
| Acetaminophen: No significant interference up to 30 mg/dL. | ||
| Acetylsalicylic acid: No significant interference up to 200 mg/dL. | ||
| Calibration Frequency | Comparable to 30 days | 28 days |
| On-board Stability | Comparable to 30 days | 28 days |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size for the clinical test set used in method comparison or interference studies. It is described as testing human serum and plasma.
The data provenance (country of origin, retrospective/prospective) is not specified in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a chemical assay, not an assessment requiring expert interpretation of images or clinical findings. The "ground truth" for the test set would be established by the predicate device's accepted analytical results, or other reference methods for analytical performance studies.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human adjudication of clinical findings.
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
Not applicable. This document describes an in vitro diagnostic reagent; there is no AI component or human reader study involved.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes an in vitro diagnostic reagent; there is no algorithm or AI component. The "standalone" performance here refers to the analytical performance of the reagent on the specified analyzer.
7. The Type of Ground Truth Used
For method comparison, the ground truth is established by comparing the results of the ELITech Clinical Systems CALCIUM ARSENAZO with analyses performed using the predicate device (Stanbio Calcium LiquiColor®) on the same samples. For precision, linearity, and interference studies, ground truth would be based on known concentrations or preparations in control materials and spiked samples. This is a form of analytical ground truth.
8. The Sample Size for the Training Set
Not applicable. There is no AI component, and thus no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for an AI model. For the analytical studies, ground truth is established through standard laboratory practices for calibrators, controls, and comparative methods.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.