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510(k) Data Aggregation
(90 days)
VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products
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VITROS Chemistry Products CI- Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products Cl-Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
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VITROS Chemistry Products ECO2 Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Bicarbonate/ carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
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VITROS Chemistry Products GLU Slides: Rx Only. For in vitro diagnostic use only. VITROS Chemistry Products GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The VITROS Chemistry MicroSlide range of products (in this case VITROS Chemistry Products Cl- Slides, VITROS Chemistry Products ECO2 Slides, and VITROS Chemistry Products GLU Slides), are combined with the VITROS XT 7600 Integrated System to perform the VITROS CI-, ECO2, and GLU assays.
The provided text describes the performance evaluation of VITROS Chemistry Products Cl- Slides, ECO2 Slides, and GLU Slides on the VITROS XT 7600 Integrated System, demonstrating their substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful outcomes of the various performance studies (method comparison, precision, linearity, detection limits, specificity). Explicit numerical acceptance criteria are not always stated for each test result in the summary, but rather the conclusion that performance was "acceptable" or "supported the claimed measuring ranges."
Summary of VITROS XT 7600 Method Comparison Regression Analysis Data
| VITROS assay | Regression Analysis Type | Slope | Intercept | Test Range (Candidate) | Claimed Measuring Range | Performance Conclusion (Implicit Acceptance) |
|---|---|---|---|---|---|---|
| CL- Serum (mmol/L) | Passing Bablok | 1.00 | -0.11 | 51.2-167.5 | 50.0-175.0 | Acceptable (close to 1 slope, 0 intercept) |
| CI- Urine (mmol/L) | Weighted Deming | 1.00 | -0.11 | 15-290 | 15-300 | Acceptable (close to 1 slope, 0 intercept) |
| ECO2 Serum (mmol/L) | Deming | 0.99 | 0.19 | 7.1-38.4 | 5.0-40.0 | Acceptable (close to 1 slope, 0 intercept) |
| GLU Serum (mg/dL) | Weighted Deming | 1.00 | 0.49 | 22.1-593.8 | 20.0-625.0 | Acceptable (close to 1 slope, 0 intercept) |
| GLU Urine (mg/dL) | Weighted Deming | 1.00 | 0.28 | 25.3-600.4 | 20.0-650.0 | Acceptable (close to 1 slope, 0 intercept) |
| GLU CSF (mg/dL) | Weighted Deming | 1.00 | 0.22 | 22.9-649.5 | 20.0-650.0 | Acceptable (close to 1 slope, 0 intercept) |
Precision (Representative samples shown for Cl- Serum and ECO2)
The precision tables present the mean, N, SD, and %CV for Repeatability (Within Run), Within Day, Between Day, Between Calibration, and Within Lab (Total) for various fluids. The acceptance criteria are implicitly that the reported %CV and SD values are within acceptable clinical laboratory standards for these analytes, though specific numeric targets are not explicitly stated in this summary.
Detection Limits
| LoB (Reported) | LoD (Reported) | LoQ (Reported) | Claimed LoQ | Assay Range | Performance Conclusion (Implicit Acceptance) | |
|---|---|---|---|---|---|---|
| Cl- Serum | 9.2202 | 9.9798 | 49 | 50 | 50.0-175.0 | Reported LoQ is close to or better than Claimed LoQ |
| Cl- Urine | 3.0965 | 4.0417 | 11 | 15 | 15-300 | Reported LoQ is close to or better than Claimed LoQ |
| ECO2 | 1.9944 | 2.3522 | 3.7 | 5.0 | 5.0-40.0 | Reported LoQ is close to or better than Claimed LoQ |
| GLU Serum | 4.5753 | 5.2670 | 13 | 20 | 20.0-625.0 | Reported LoQ is close to or better than Claimed LoQ |
| GLU Urine | 6.2966 | 6.7212 | 20 | 20 | 20.0-650.0 | Reported LoQ is equal to Claimed LoQ |
| GLU CSF | 4.0745 | 4.6992 | 19 | 20 | 20.0-650.0 | Reported LoQ is close to or better than Claimed LoQ |
The acceptance criterion for LoQ is explicitly mentioned: "Ortho defines LoQ as the lowest concentration with an imprecision of ≤20% and percent total allowable error
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(148 days)
VITROS Chemistry Products Cl- Slides
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 |
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