Search Results
Found 1 results
510(k) Data Aggregation
(148 days)
Rx. For in vitro diagnostic use only .VITROS® Chemistry Products Cl⁻ Slides quantitatively measure chloride (Cl⁻) concentration in serum, plasma, and urine using VITROS® Chemistry Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The VITROS® Chemistry Products Cl⁺ Slide assay is performed using the VITROS® Chemistry Products Cl⁺ Slide and the VITROS® Chemistry Products Calibrator Kit 2 on the VITROS Chemistry Systems.
The VITROS® Cl- Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for measurement of chloride ions. All reactions necessary for a single quantitative measurement of chloride take place within the multi-layered analytical element of a VITROS® Chemistry Products Cl⁺ slide. The slide consists of two ion- selective electrodes, each containing a protective layer, a silver layer and a silver chloride layer coated on a polyester support support. The protective layer inhibits interference from normal levels of bromide and uric acid.
The provided text describes the performance summary of the VITROS Chemistry Products Cl- Slides, a device for quantitatively measuring chloride (Cl-) concentration in serum, plasma, and urine. It does not contain information about an AI-powered device or an MRMC comparative effectiveness study. Therefore, sections related to AI, expert involvement, and MRMC studies cannot be filled from this document.
Here's a summary of the acceptance criteria and study detailed in the document for the VITROS Chemistry Products Cl- Slides:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria / Study Method | Reported Device Performance |
|---|---|---|
| Method Comparison | CLSI Protocol EP09-A3 (Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 2013). Comparison against Siemens Chloride (CL) method for ADVIA® Chemistry Systems. | VITROS CI Slides = 0.996 x [Siemens] - 4.7 mmol/L with a correlation coefficient (r) of 0.998. This demonstrates excellent correlation with the predicate device. |
| Precision | CLSI Protocol EP05-A3 (Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition). Pooled estimates of two reagent lots. Two runs per day for 20 nonconsecutive days, with four precision samples in duplicate per run. | Within-Day CV%: 0.4% - 3.3% Within-Lab CV%: 0.6% - 4.2% (across different mean concentrations: 18, 105, 191, 282 mmol/L). These CV% values are very low, indicating high precision of the device across the measuring range. |
| Limit of Blank (LoB) | CLSI EP17-A2 (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures). | 1.1 mmol/L. |
| Limit of Detection (LoD) | CLSI EP17-A2 (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures). Proportions of false positives (α) and false negatives (β) less than 5%; based on 180 determinations, with 4 blank and 6 low-level samples. | 2.2 mmol/L. |
| Limit of Quantitation (LoQ) | CLSI EP17-A2 (Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures). Imprecision within 5%. | 5 mmol/L. |
| Linearity | CLSI EP06-A (Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline). Evaluation across one slide lot on one VITROS 5,1 FS Chemistry System using a commercial linearity panel. | Linear Regression Equation: Y = 1.0044x - 1.37 with a Correlation Coefficient, R2 = 0.9995. This indicates excellent linearity across the determined range of 12 to 320 mmol/L, supporting the proposed measuring range. |
| Measuring Range | Determined by assessing LoQ and linearity results from three slide lots and limited by the predicate method's lower range (15 mmol/L). | 15 to 300 mmol/L for urine. |
| Expected Values (Random Urine) | CLSI EP28-A3c (Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition). Evaluation of 135 normal patient samples using two slide lots on one VITROS 5,1 FS Chemistry System. | 17 to 209 mmol/L. |
| Expected Values (24-hour Urine) | Based on a literature reference. | 110 - 250 mmol/day (from Wu, Alan H.B. Tietz Clinical Guide to Laboratory Tests. 4th ed. Saunders Elsevier, St. Louis, MO: 2006, 234-241). |
| Interfering Substances | CLSI Protocol EP07-A2 (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). Acceptance criterion for bias was not explicitly stated but implied by "bias < 5%" for non-interfering substances. | Known Interferences: Bromide and iodide from therapeutic drugs and ointments (positive bias). Specimens Not Recommended: Urine with Hydrochloric acid (12N HCl) or 10% Thymol in isopropanol preservatives. Substances that Do Not Interfere: Numerous common substances (e.g., Acetaminophen, Ascorbic Acid, Bilirubin, Ibuprofen) at specified concentrations, with observed bias < 5%. pH (4-9) and Specific Gravity (1.00-1.04) also found not to interfere. |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison: 130 human urine samples were tested. 125 of these samples were within the measuring range of both the VITROS CT assay and the Siemens Chloride assay. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it refers to "human urine samples" and "patient samples" which typically implies clinical samples.
- Precision: Four precision samples were used, two commercially available control materials in a human urine matrix, and two prepared in a polyvinylpyrrolidone (PVP) matrix. Each sample was run in duplicate, two runs per day, for 20 nonconsecutive days. This totals 80 observations per sample type (4 samples * 2 replicates * 2 runs * 20 days / 4 samples = 80 observations (No. Observ. in table is for each sample)).
- Limit of Blank (LoB), Limit of Detection (LoD), Limit of Quantitation (LoQ): Based on 180 determinations, with 4 blank and 6 low-level samples.
- Linearity: A commercial urine linearity panel was used, consisting of 5 additional levels prepared from admixtures of high and low pools, and an additional four levels targeting lower chloride concentrations, for a total of 11 levels.
- Expected Values (Random Urine): An "in-house collection of 135 normal patient samples" was evaluated.
- Interfering Substances: The study involved testing various substances at specified concentrations; the exact number of unique samples or tests for this section is not precisely quantified, but it's implied by the long list of tested substances and their concentrations.
Data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. "Human urine samples" and "normal patient samples" suggest clinical origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes an in vitro diagnostic device that measures chloride levels. The "ground truth" for such devices is typically established through reference methods or established assays, not through expert consensus on medical images or clinical observations. Therefore, there is no information provided about experts or their qualifications for establishing ground truth in the context of this device.
4. Adjudication Method for the Test Set
Not applicable. The device performs a quantitative chemical measurement. Adjudication methods (like 2+1, 3+1) are typically used for qualitative or subjective assessments, such as in image interpretation studies, where human readers might disagree.
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 device for chemical analysis, not an AI-powered diagnostic tool for human readers. There is no mention of human readers, AI assistance, or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device, the VITROS Chemistry Products Cl- Slides, is a standalone in vitro diagnostic assay that performs quantitative measurements of chloride. It operates independently of human interpretation in its primary function of providing a numerical chloride concentration. The provided performance data (method comparison, precision, linearity, etc.) inherently reflect its standalone performance.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is based on:
- Reference methods/predicate devices: For method comparison, the Siemens ADVIA® Chloride (CL) assay was used as the predicate (gold standard).
- Known concentrations: For precision, linearity, LoB/LoD/LoQ studies, materials with known or carefully characterized chloride concentrations (commercial controls, prepared panels, blank samples, low-level samples) were used.
- Literature references: For 24-hour urine expected values, a published medical textbook was referenced.
- Normal patient samples: For random urine expected values, a collection of normal patient samples was used to define the reference interval, presumably with their chloride levels being the "ground truth" for what is considered normal.
8. The Sample Size for the Training Set
This document describes the validation of an in vitro diagnostic assay, not a machine learning or AI model. Therefore, the concept of a "training set" in the context of AI is not applicable. The studies described are for validation of the device's performance characteristics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI sense for this type of device. The ground truth for the various performance studies (as described in point 7) was established through reference methods, known concentrations, and literature.
Ask a specific question about this device
Page 1 of 1