(90 days)
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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
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.