(30 days)
No
The description focuses on the chemical reactions and spectrophotometric measurements used to determine glucose and calcium concentrations. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is for in vitro diagnostic use, meaning it measures substances in samples (like blood or urine) for diagnostic purposes, not for treating a condition directly.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and explains that the measurements are "used in the diagnosis and treatment of carbohydrate metabolism disorders... and of pancreatic islet cell carcinoma" for glucose, and "in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany" for calcium. This language directly indicates its use for diagnosis.
No
The device is a physical slide containing chemical reagents for in vitro diagnostic testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only".
- Nature of the Test: The device measures the concentration of glucose and calcium in biological samples (serum, plasma, urine, and cerebrospinal fluid). This is a classic example of an in vitro diagnostic test, as it analyzes samples taken from the body to provide information about a person's health status.
- Intended Use in Diagnosis and Treatment: The intended use clearly states that the measurements are used in the "diagnosis and treatment" of various conditions related to carbohydrate metabolism and calcium levels. This aligns with the definition of an IVD, which is used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use only
The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders mellitus. neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca) concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. 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).
Special conditions for use statement: For prescription use only.
Product codes
CGA, CJY
Device Description
The new device, the VITROS XT Chemistry Products GLU-Ca Slides is a single device that contains both a GLU test and a Ca test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.
For glucose measurement, a drop of patient sample is deposited on the GLU test element of the slide and is evenly distributed by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light. The dye system used is closely related to that first reported by Trinder. ' The chemistry of the glucose slides has been described by Curme, et al.
For calcium measurement, a drop of patient sample is deposited on the Ca test element of the slide and is evenly distributed by the spreading layer to the underlying layers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. There, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
Sample type: Serum, urine, and cerebrospinal fluid (glucose only) samples.
Sample size:
GLU Serum: 116
GLU Urine: 103
GLU CSF: 149
Ca Serum: 112
Ca Urine: 119
Test Device: VITROS XT Chemistry Products GLU-Ca Slides using the VITROS XT 7600 Integrated System.
Predicate Devices: VITROS Chemistry Products GLU Slides and VITROS Chemistry Products Ca Slides using the VITROS 5600 Integrated System.
Method: CLSI Protocol EP09c. Measurement Procedure Comparison and Bias Estimation Using Patient Samples. Weighted Deming regressions were performed for GLU (all fluid types) and Ca (urine). Ordinary Deming regression was performed for Ca serum.
Key Results:
GLU Serum: Slope 0.99, Intercept -0.91, Corr. Coeff. 1.000, Test Range 25 - 571, Measuring range 20 - 625
GLU Urine: Slope 1.01, Intercept -0.18, Corr. Coeff. 1.000, Test Range 24-642, Measuring range 20 - 650
GLU CSF: Slope 0.98, Intercept -0.06, Corr. Coeff. 1.000, Test Range 21-596, Measuring range 20 - 650
Ca Serum: Slope 0.99, Intercept 0.04, Corr. Coeff. 0.999, Test Range 1.4-13.9, Measuring range 1.0 - 14.0
Ca Urine: Slope 0.99, Intercept 0.07, Corr. Coeff. 0.999, Test Range 2.2-17.2, Measuring range 1.0 - 17.8
Precision:
Sample type: Patient pools and quality control materials (serum, urine, CSF for GLU; serum and urine for Ca).
Sample size: 80 observations (2 replicates per run, 2 runs per day over 20 days) for each matrix.
Method: CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Third Edition.
Key Results:
GLU Serum: CV% ranges from 0.3-0.6 for repeatability, 0.8-1.0 for within day, and 0.9-1.2 for within lab.
GLU Urine: CV% ranges from 0.5-1.2 for repeatability, 0.6-1.8 for within day, and 0.6-1.9 for within lab.
GLU CSF: CV% ranges from 0.4-0.8 for repeatability, 0.6-1.2 for within day, and 0.6-1.2 for within lab.
Ca Serum: CV% ranges from 0.5-1.7 for repeatability, 0.6-2.6 for within day, and 0.9-2.9 for within lab.
Ca Urine: CV% ranges from 0.7-2.3 for repeatability, 1.0-3.5 for within day, and 1.1-3.4 for within lab.
Detection Limits:
Method: CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures. LoQ determination was set on pre-defined Total Error (TE) goals based on the Westgard model.
Key Results:
GLU (mg/dL):
Serum: LOB 1.0, LOD 1.9, LOQ 15.9, Claimed LOQ 20
Urine: LOB 2.5, LOD 3.0, LOQ 13.0, Claimed LOQ 20
CSF: LOB 1.0, LOD 1.9, LOQ 15.2, Claimed LOQ 20
Ca (mg/dL):
Serum: LOB 0.10, LOD 0.14, LOQ 0.49, Claimed LOQ 1.0
Urine: LOB 0.05, LOD 0.09, LOQ 0.60, Claimed LOQ 1.0
Linearity:
Method: CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003). A series of twenty proportionally related admixtures of low and high test fluids were tested in quadruplicate.
Key Results: The linearity studies support the claimed measuring ranges for the individual tests within the VITROS XT GLU-Ca Slides.
GLU: Serum/plasma Linear Range 19.3-635.3 (Measuring Range 20-625), Urine Linear Range 15.4-776.1 (Measuring Range 20-650), CSF Linear Range 19.2-650.9 (Measuring Range 20-650)
Ca: Serum/plasma Linear Range 0.85-15.82 (Measuring Range 1.0-14.0), Urine Linear Range 0.75-20.67 (Measuring Range 1.0-17.8)
Specificity:
Method: CLSI document EP07, Interference Testing in Clinical Chemistry. Supplemental tables in CLSI document EP37 were referenced for recommended testing concentrations. Point estimates of effects were made using the paired difference method. Dose-response analysis was conducted.
Key Results:
GLU Test:
Serum: Interference observed for Glutathione (-10.4 mg/dL bias at 73 mg/dL glucose), Hemoglobin (7.6 mg/dL bias at 79 mg/dL glucose), Total Protein (8.8 mg/dL bias at 74 mg/dL glucose, 20.4 mg/dL bias at 217 mg/dL glucose). No interference observed for 79 substances.
Urine: Interference observed for Ascorbic acid (-14.0 mg/dL bias at 31 mg/dL glucose, -13.7 mg/dL bias at 171 mg/dL glucose), Dextran (8.0 mg/dL bias at 31 mg/dL glucose, 14.4 mg/dL bias at 169 mg/dL glucose), Hemoglobin (8.5 mg/dL bias at 33 mg/dL glucose), N-Acetylcysteine (-14.0 mg/dL bias at 166 mg/dL glucose). No interference observed for 18 substances.
CSF: Interference observed for Hemoglobin (5.0 mg/dL bias at 47 mg/dL glucose, 12.1 mg/dL bias at 69 mg/dL glucose, 10.2 mg/dL bias at 87 mg/dL glucose).
Ca Test:
Serum: Interference observed for Cefoxitin (0.28 mg/dL bias at 7.7 mg/dL calcium, 0.50 mg/dL bias at 11.3 mg/dL calcium), Cholesterol (0.34 mg/dL bias at 6.3 mg/dL calcium, 0.34 mg/dL bias at 9.5 mg/dL calcium), Gadodiamide (0.35 mg/dL bias at 7.4 mg/dL calcium), Hemoglobin (-0.30 mg/dL bias at 8.3 mg/dL calcium), Sodium (0.35 mg/dL bias at 7.4 mg/dL calcium, 0.52 mg/dL bias at 11.1 mg/dL calcium), Sorbitol (-0.37 mg/dL bias at 11.9 mg/dL calcium), Total Protein (-0.45 mg/dL bias at 12.1 mg/dL calcium). No interference observed for 75 substances.
Urine: No interfering compounds observed. No interference observed for 20 substances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. 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.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."
April 3, 2019
Ortho-Clinical Diagnostics, Inc. Darlene Phillips Manager, Regulatory Affairs 100 Indigo Creek Drive Rochester, NY 14626
Re: K190520
Trade/Device Name: VITROS XT Chemistry Products GLU-Ca Slides Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CJY Dated: February 28, 2019 Received: March 4, 2019
Dear Darlene Phillips:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to Mav 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kellie B. Kelm -S
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190520
Device Name VITROS XT Chemistry Products GLU-Ca Slides
Indications for Use (Describe)
For in vitro diagnostic use only
The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS XT 7600 Integrated Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders mellitus. neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca) concentration in serum, plasma, and urine using VITROS XT 7600 Integrated Systems. 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).
Special conditions for use statement: For prescription use only.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K190520
Submitter's Information
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-4253 Fax: (585) 453-3113
Contact Person:
Darlene J Phillips, RAC Manager, Regulatory Affairs
Date of Preparation: February 28, 2019
Device Proprietary Name(s):
VITROS XT Chemistry Products GLU-Ca Slides
Common Names:
Glucose test Calcium test
Classification Names
| Test | Product
Code | Class | Regulation Section | Panel |
|------|-----------------|----------|--------------------------------------|---------------|
| GLU | CGA | Class II | 21 CFR 862. 1345 Glucose test system | Clinical |
| Ca | CJY | Class II | 21 CFR 862. 1145 Calcium test system | Chemistry(75) |
Predicate Device(s)
| Predicate Devices | FDA 510(k) Number |
|---|---|
| VITROS Chemistry Products GLU Slides | K182072 |
| VITROS Chemistry Products Ca Slides | K072440 |
4
Intended Use Statement(s) VITROS XT Chemistry Products GLU-Ca Slides
Rx Only. For in vitro diagnostic use only.
The GLU test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures glucose (GLU) concentration in serum, plasma, urine, and cerebrospinal fluid using VITROS 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 Ca test within the VITROS XT Chemistry Products GLU-Ca Slides quantitatively measures calcium (Ca) concentration in serum. plasma, and urine using VITROS XT 7600 Integrated Systems. 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).
Device Description
The new device, the VITROS XT Chemistry Products GLU-Ca Slides is a single device that contains both a GLU test and a Ca test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.
For glucose measurement, a drop of patient sample is deposited on the GLU test element of the slide and is evenly distributed by the spreading layer to the underlying layers. The oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of the dye is measured by reflected light. The dye system used is closely related to that first reported by Trinder. ' The chemistry of the glucose slides has been described by Curme, et al.
For calcium measurement, a drop of patient sample is deposited on the Ca test element of the slide and is evenly distributed by the spreading layer to the underlying layers. The bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the underlying reagent layer. There, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum. After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored complex formed is proportional to the calcium concentration in the sample.
Trinder P. Determination of Glucose in Blood Using Glucose Oxidase with an l Alternative Oxygen Receptor. Ann. Clin. Biochem. 6:24; 1969.
Curme HG. et al. Multilayer Film Elements for Clinical Analysis. Clin. Chem. 2. 24:1335—1342; 1978.
5
Comparison to Predicate Devices
The following tables show similarities and differences between the new and predicate devices.
| Summary of the technological characteristics of the device compared to the
| predicate device | ||
|---|---|---|
| Device | ||
| Characteristic | New Device | |
| VITROS XT GLU-Ca Slide | ||
| (New) | Predícate Devices | |
| VITROS GLU Slide [K182072] | ||
| VITROS Ca Slide [K072440] | ||
| (Current) | ||
| Intended Use | Same for each individual test |
For in vitro diagnostic use only.
The GLU test within the VITROS
XT Chemistry Products GLU-
Ca Slides quantitatively
measures glucose (GLU)
concentration in serum, plasma,
urine, and cerebrospinal fluid
(CSF).
The Ca test within the VITROS
XT Chemistry Products
GLU-Ca Slides quantitatively
measures calcium (Ca)
concentration in serum,
plasma, and urine. | For in vitro diagnostic use only.
VITROS Chemistry Products GLU
Slides quantitatively measure
glucose (GLU) concentration in
serum, plasma, urine, and CSF.
VITROS Chemistry Products Ca
Slides quantitatively measure
calcium (Ca) concentration in
serum, plasma, and urine. |
| Device
Description | No Change | Multilayered, analytical element
coated on a polyester support |
| Basic Principle | No Change | GLU Colorimetric
Ca Colorimetric |
| Incubation time
and temperature | No Change | Approximately 5 minutes
37°C (98.6° F) |
| Sample type | No Change | GLU Serum, plasma, urine and
cerebrospinal fluid (CSF)
Ca Serum, plasma and urine |
| Amount of Slide
Reactive
Ingredients per
cm² (test) | No Change
The composition of the analytical
element of each test within the
VITROS XT Slide will remain
the same as that used in each
predicate device | GLU Glucose oxidase (Aspergillus sp.)
0.77 U; peroxidase (horseradish
root) 3.6 U; 1,7-
dihydroxynaphthalene (dye
precursor) 67 µg and 4-
aminoantipyrine hydrochloride
(dye precursor) 0.11 mg.
Ca Arsenazo III dye 60 ug |
| Summary of the technological characteristics of the device compared to the
predicate device | | |
| Device
Characteristic | New Device
VITROS XT GLU-Ca Slide
(New) | Predícate Devices
VITROS GLU Slide [K182072]
VITROS Ca Slide [K072440]
(Current) |
| Assay Range | No Change | GLU (mg/dL)
Serum/plasma 20 - 625
Urine 20 - 650
CSF 20 - 650
Ca (mg/dL)
Serum/plasma 1.0 - 14.0
Urine 1.0 – 17.8 |
| Calibrators | Same | VITROS Chemistry Products
Calibrator Kit 1 |
| Controls | Same | VITROS Chemistry Products
Performance Verifier I and II
VITROS Chemistry Products Liquid
Performance Verifier I and II |
| Differences | | |
| Instrumentation | VITROS XT 7600 Integrated
System | VITROS 250/350, 5,1 FS and 4600
Chemistry Systems
VITROS 5600 and XT 7600 |
Summary of the technological characteristics of the device compared to the
6
Integrated Systems
GLU
Ca
6 µL
10 µL
વ...
Non-Clinical Testing Analytical Performance
GLU
Ca
Method Comparison
Sample volume
Method Comparison testing followed CLSI Protocol EP09c. Measurement Procedure Comparison and Bias Estimation Using Patient Samples. Serum, urine and cerebrospinal fluid (glucose only) samples were evaluated on the VITROS XT Chemistry Products GLU-Ca Slides using the VITROS XT 7600 Integrated System and on VITROS Chemistry Products GLU Slides and VITROS Chemistry Products Ca Slides using the VITROS 5600 Integrated System. The correlation between the predicate and the new tests within the VITROS XT GLU-Ca Slides on the VITROS XT 7600 Integrated System is summarized below.
2.7 µL
3.5 µL
Weighted Deming regressions were performed to determine the correlation for GLU (all fluid types) and Ca (urine). Ordinary Deming regression was performed to determine the correlation between the Ca serum methods.
7
| Summary of Method Comparison Regression Analysis DataUnits mg/dL | ||||||
|---|---|---|---|---|---|---|
| Test | N | Slope | Intercept | Corr. Coeff. | Test Range | Measuring range |
| GLU Serum | 116 | 0.99 | -0.91 | 1.000 | 25 - 571 | 20 - 625 |
| GLU Urine | 103 | 1.01 | -0.18 | 1.000 | 24-642 | 20 - 650 |
| GLU CSF | 149 | 0.98 | -0.06 | 1.000 | 21-596 | 20 - 650 |
| Ca Serum | 112 | 0.99 | 0.04 | 0.999 | 1.4-13.9 | 1.0 - 14.0 |
| Ca Urine | 119 | 0.99 | 0.07 | 0.999 | 2.2-17.2 | 1.0 - 17.8 |
Precision
Precision was evaluated with patient pools and quality control materials following CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Third Edition, using the VITROS XT Chemistry Products GLU-Ca Slides on the VITROS XT 7600 Integrated System. The test included 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum and urine for the Ca test and serum, urine, and CSF for the GLU test. The long term precision analysis is summarized below.
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect reproducibility of test results.
| GLU Serum Units (mg/dL) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Mean | Repeatability* | Within Day** | Within Lab*** | No. of | No. of | |||
| Conc. | SD | CV% | SD | CV% | SD | CV% | Obs. | Days |
| 42 | 0.3 | 0.6 | 0.4 | 1.0 | 0.4 | 1.0 | 80 | 20 |
| 87 | 0.4 | 0.4 | 0.8 | 0.9 | 0.8 | 0.9 | 80 | 20 |
| 105 | 0.5 | 0.4 | 1.0 | 0.9 | 1.0 | 0.9 | 80 | 20 |
| 121 | 0.6 | 0.5 | 1.3 | 1.1 | 1.4 | 1.2 | 80 | 20 |
| 292 | 0.9 | 0.3 | 2.4 | 0.8 | 2.6 | 0.9 | 80 | 20 |
| 573 | 2.0 | 0.4 | 5.0 | 0.9 | 5.3 | 0.9 | 80 | 20 |
| GLU Urine Units (mg/dL) | ||||||||
| Mean | Repeatability* | Within Day** | Within Lab*** | No. of | No. of | |||
| Conc. | SD | CV% | SD | CV% | SD | CV% | Obs. | Days |
| 26 | 0.3 | 1.2 | 0.5 | 1.8 | 0.5 | 1.9 | 80 | 20 |
| 43 | 0.3 | 0.7 | 0.4 | 1.0 | 0.5 | 1.1 | 80 | 20 |
| 44 | 0.4 | 0.8 | 0.5 | 1.0 | 0.5 | 1.1 | 80 | 20 |
| 114 | 0.5 | 0.5 | 0.7 | 0.6 | 0.7 | 0.6 | 80 | 20 |
| 292 | 1.5 | 0.5 | 1.7 | 0.6 | 1.7 | 0.6 | 80 | 20 |
8
| GLU CSF Units (mg/dL) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Mean | ||||||||
| Conc. | Repeatability* | |||||||
| SD | CV% | Within Day** | ||||||
| SD | CV% | Within Lab*** | ||||||
| SD | CV% | No. of | ||||||
| Obs. | No. of | |||||||
| Days | ||||||||
| 37 | 0.3 | 0.8 | 0.4 | 1.1 | 0.4 | 1.1 | 80 | 20 |
| 38 | 0.3 | 0.8 | 0.5 | 1.2 | 0.5 | 1.2 | 80 | 20 |
| 39 | 0.3 | 0.7 | 0.4 | 1.1 | 0.5 | 1.2 | 80 | 20 |
| 87 | 0.4 | 0.4 | 0.6 | 0.7 | 0.6 | 0.7 | 80 | 20 |
| 318 | 1.4 | 0.4 | 1.7 | 0.6 | 2.0 | 0.6 | 80 | 20 |
| 644 | 2.7 | 0.4 | 3.5 | 0.6 | 3.6 | 0.6 | 80 | 20 |
| Ca Serum Units (mg/dL) | ||||||||
| Mean | ||||||||
| Conc. | Repeatability* | |||||||
| SD | CV% | Within Day** | ||||||
| SD | CV% | Within Lab*** | ||||||
| SD | CV% | No. of | ||||||
| Obs. | No. of | |||||||
| Days | ||||||||
| 2.3 | 0.04 | 1.7 | 0.06 | 2.6 | 0.07 | 2.9 | 80 | 20 |
| 6.8 | 0.04 | 0.6 | 0.06 | 0.8 | 0.09 | 1.4 | 80 | 20 |
| 8.4 | 0.07 | 0.8 | 0.08 | 0.9 | 0.10 | 1.2 | 80 | 20 |
| 8.8 | 0.05 | 0.6 | 0.07 | 0.8 | 0.08 | 0.9 | 80 | 20 |
| 11.9 | 0.07 | 0.6 | 0.08 | 0.7 | 0.11 | 1.0 | 80 | 20 |
| 12.2 | 0.06 | 0.5 | 0.07 | 0.6 | 0.11 | 0.9 | 80 | 20 |
| Ca Urine | ||||||||
| Units (mg/dL) | ||||||||
| Mean | ||||||||
| Conc. | Repeatability* | |||||||
| SD | CV% | Within Day** | ||||||
| SD | CV% | Within Lab*** | ||||||
| SD | CV% | No. of | ||||||
| Obs. | No. of | |||||||
| Days | ||||||||
| 2.1 | 0.05 | 2.3 | 0.07 | 3.5 | 0.07 | 3.4 | 80 | 20 |
| 5.0 | 0.04 | 0.7 | 0.05 | 1.0 | 0.06 | 1.1 | 80 | 20 |
| 5.6 | 0.05 | 0.8 | 0.06 | 1.1 | 0.07 | 1.2 | 80 | 20 |
| 6.6 | 0.04 | 0.6 | 0.07 | 1.1 | 0.09 | 1.3 | 80 | 20 |
| 9.7 | 0.08 | 0.8 | 0.08 | 0.8 | 0.10 | 1.1 | 80 | 20 |
| 15.7 | 0.11 | 0.7 | 0.16 | 1.0 | 0.28 | 1.8 | 80 | 20 |
*Repeatability (formerly called within-run precision) was determined using two replicates per run.
**Within Day precision was determined using two runs/day with two replications per run
***Within Lab precision was determined using a single lot of slides and a single calibration
Detection Limits
Detection capability studies for the GLU and Ca tests within the VITROS XT GLU-Ca Slides were evaluated according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
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LoQ determination was set on pre-defined total error (TE) goals based on the Westgard model, a combination of bias and precision. The Total Error goal used to accept the LoO for GLU was ≤ 4.8 mg/dL for serum, ≤ 3.9 mg/dL for urine and ≤ 4.6 mg/dL for CSF. The Total Error goal used to accept the LoQ for Ca was ≤ 0.15 mg/dL for serum and ≤ 0.42 mg/dL for urine.
| GLU (mg/dL) | Ca (mg/dL) | ||||
|---|---|---|---|---|---|
| Serum | Urine | CSF | Serum | Urine | |
| LOB | 1.0 | 2.5 | 1.0 | 0.10 | 0.05 |
| LOD | 1.9 | 3.0 | 1.9 | 0.14 | 0.09 |
| LOQ | 15.9 | 13.0 | 15.2 | 0.49 | 0.60 |
| Claimed LOQ | 20 | 20 | 20 | 1.0 | 1.0 |
The results of this analysis are summarized below:
Linearitv
Linearity studies were performed according to CLSI EP06-A, Evaluation of the Linearity of Ouantitative Measurement Procedures: A Statistical Approved Guideline (2003). VITROS XT GLU-Ca Slides were tested on the VITROS XT 7600 Integrated System. A series of twenty proportionally related admixtures of low and high test fluids were tested to verify linearity of the GLU and Ca serum and urine tests and the GLU CSF test; each sample was tested in quadruplicate. The linearity studies support the claimed measuring ranges for the individual tests within the VITROS XT GLU-Ca Slides.
| Assay | Fluid | Measuring Range
(mg/dL) | Linear Range
(mg/dL) |
|-------|--------------|----------------------------|-------------------------|
| GLU | Serum/plasma | 20-625 | 19.3-635.3 |
| | Urine | 20-650 | 15.4-776.1 |
| | CSF | 20-650 | 19.2-650.9 |
| Ca | Serum/plasma | 1.0-14.0 | 0.85-15.82 |
| | Urine | 1.0-17.8 | 0.75-20.67 |
Serum and plasma samples with values greater than the measuring range may be diluted with one part sample to one part diluent. A 7% BSA solution was found to be an acceptable diluent for the GLU test within the VITROS XT Chemistry Products GLU-Ca Slides. Isotonic saline and reagent-grade water were found to be acceptable diluents for the Ca test within the VITROS XT Chemistry Products GLU-Ca Slides.
Urine samples with values greater than the measuring range may be diluted with one part sample to one part diluent. Isotonic saline and reagent-grade water were found to be acceptable diluents for the GLU test within the VITROS XT Chemistry Products GLU-Ca Slides. Reagent-grade water was found to be an acceptable diluent for the Ca test within the VITROS XT Chemistry Products GLU-Ca Slides.
Expected Values
The expected values of the GLU and Ca tests within the VITROS XT GLU-Ca Slides are the not changed from those of the predicate assays. Each laboratory should confirm the validity of these intervals for the population it serves.
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GLU Reference Interval
GLU reference intervals for serum, urine and CSF are based on external studies 1.
| GLU Test Expected Values | |
|---|---|
| Serum | |
| Fasting adults | 74-100 mg/dL |
| Urine | |
| Random | 1-15 mg/dL |
| 24 hour | 200 mg/dL), there may be a negative bias due to catalase released from the lysis of red blood cells. The VITROS XT Systems can perform Sample Indices using the MicroSensor module, and the GLU result from samples with visible hemolysis will be flagged with H (Hemolysis). |
- Elevated lipids may limit diffusion of oxygen to the reactants. Dilute grossly lipemic samples twofold before analysis.
Interference was observed with four (4) substances tested in urine.
| GLU Urine Known Interfering Substances | |||
|---|---|---|---|
| Interferent | Interferent | ||
| Concentration | Glucose | ||
| Concentration | |||
| (mg/dL) | Bias | ||
| (mg/dL) | |||
| Ascorbic acid | 50 mg/dL | 31 | -14.0 |
| Ascorbic acid | 13 mg/dL | 171 | -13.7 |
| Dextran | 7.5 g/dL | 31 | 8.0 |
| Dextran | 2.5 g/dL | 169 | 14.4 |
| Hemoglobin | 250 mg/dL | 33 | 8.5 |
| N-Acetylcysteine | 25 mg/dL | 166 | -14.0 |
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| GLU CSF Known Interfering Substances | |||
|---|---|---|---|
| Interferent | Interferent | ||
| Concentration | Glucose Concentration | ||
| (mg/dL) | Bias | ||
| (mg/dL) | |||
| Hemoglobin | 250 mg/dL | 47 | 5.0 |
| Hemoglobin | 1000 mg/dL | 69 | 12.1 |
| Hemoglobin | 1000 mg/dL | 87 | 10.2 |
One (1) substance was tested and found to cause interference in cerebrospinal fluid (CSF).
For the GLU test within VITROS XT GLU-Ca Slides, no interference was observed for seventy-nine (79) substances tested in serum, bias