(27 days)
Not Found
No
The device description and performance studies focus on chemical reactions and spectrophotometry for quantitative measurements, with no mention of AI or ML algorithms.
No.
The device is an in vitro diagnostic (IVD) device used to quantitatively measure triglyceride and cholesterol concentrations in serum and plasma, which are used in the diagnosis and treatment of patients, but the device itself does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" and explains that triglyceride and cholesterol measurements are "used in the diagnosis and treatment of patients" for various conditions.
No
The device description clearly details a physical, multilayered analytical element coated on a polyester support, which is a hardware component. The mechanism of action involves chemical reactions on this physical slide, measured by reflectance spectrophotometry, which also implies hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use only" in the "Intended Use / Indications for Use" section.
- Intended Use: The intended use is to "quantitatively measure triglyceride (TRIG) concentration in serum and plasma" and "quantitatively measure cholesterol (CHOL) concentration in serum and plasma". These measurements are used "in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders" and "in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases." This clearly indicates the device is used to analyze samples from the human body to provide information for diagnosis and treatment.
- Device Description: The description details a laboratory test using chemical reactions on a slide with patient samples (serum and plasma). This is a typical format for an in vitro diagnostic test.
- Performance Studies: The performance studies described (Method Comparison, Precision, Detection Capability, Linearity, Specificity) are standard types of studies conducted to validate the performance of in vitro diagnostic devices.
- Predicate Devices: The predicate devices listed (K130332 VITROS Chemistry Products TRIG Slides and K820263 VITROS Chemistry Products CHOL Slides) are also IVD devices, indicating the new device is in the same category.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Rx Only For in vitro diagnostic use only
The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders.
The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
Product codes (comma separated list FDA assigned to the subject device)
CHH, CDT
Device Description
The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support 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.
To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry.
To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.
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:
- Study Type: Method Comparison, followed CLSI Protocol EP09c, Measurement Procedure Comparison and Bias Estimation Using Patient Samples.
- Sample Size: 148 patient serum samples
- Key Results:
- TRIG Serum: Slope = 0.99, Intercept = 1.49, Corr. Coeff. = 1.000, Test Range = 17 - 519 mg/dL, Measuring range = 10 - 525 mg/dL
- CHOL Serum: Slope = 0.97, Intercept = 0.09, Corr. Coeff. = 0.999, Test Range = 72 - 315 mg/dL, Measuring range = 50 - 325 mg/dL
Precision:
- Study Type: Precision, evaluated with patient pools and quality control materials following CLSI Protocol EP05-A3, Evaluation of Precision Performance of Quantitative Methods; Approved Guideline-Third Edition.
- Sample Size: 80 observations (2 replicates per run, 2 runs per day over 20 days) for serum.
- Key Results: See tables for TRIG Serum and CHOL Serum. For TRIG values ranged from CV% 0.3-0.9; for CHOL from 0.7-2.1%
Detection Capability:
- Study Type: Detection capability studies, evaluated according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
- Sample Size: 180 total LoQ determinations for each test.
- Key Results:
- TRIG Test: Limit of Quantitation (LoQ) = 10 mg/dL (Claimed); LOB = 3.8 mg/dL, LOD = 4.1 mg/dL, LOQ = 6.5 mg/dL.
- CHOL Test: Limit of Quantitation (LoQ) = 50 mg/dL (Claimed); LOB = 1.8 mg/dL, LOD = 2.1 mg/dL, LOQ = 17.6 mg/dL.
Linearity:
- Study Type: Linearity studies, performed according to CLSI EP06-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approved Guideline (2003).
- Sample Size: A series of eighteen proportionally related admixtures of low and high test fluids were tested; each sample was tested in quadruplicate.
- Key Results:
- TRIG Serum/plasma: Measuring Range = 10 - 525 mg/dL, Linear Range = 8.0 - 542.8 mg/dL, Claimed Linearity = 10 - 525 mg/dL.
- CHOL Serum/plasma: Measuring Range = 50 - 325 mg/dL, Linear Range = 27 - 358 mg/dL, Claimed Linearity = 50 - 325 mg/dL.
Specificity:
- Study Type: Interference testing, screened for interfering substances following CLSI EP07-03, Interference Testing in Clinical Chemistry and referenced CLSI EP37 for recommended testing concentrations.
- Key Results:
- TRIG Test: Interference observed for Dextran 40 and Total protein. No interference for seventy-eight (78) substances.
- CHOL Test: Interference observed for Ascorbic acid, Cefazolin, Dextran 40, Glutathione, Hemoglobin, N-Acetylcysteine, and Total protein. No interference for seventy-nine (79) substances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Bias for specificity and concentration ranges for precision are provided.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Image /page/0/Picture/0 description: The image shows the logo for 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 text logo on the right. The FDA text logo is in blue and includes the letters "FDA" stacked above the words "U.S. FOOD & DRUG ADMINISTRATION".
March 27, 2019
Ortho-Clinical Diagnostics, Inc. Alexandra Chamberlain Senior Regulatory Associate, Regulatory Affairs 100 Indigo Creek Drive Rochester, NY 14626
Re: K190490
Trade/Device Name: VITROS XT Chemistry Products TRIG-CHOL Slides Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets the limitation to the exemption 21 CFR 862.9 (c)(4) Product Code: CHH, CDT Dated: February 27, 2019 Received: February 28, 2019
Dear Alexandra Chamberlain:
We have reviewed your 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 May 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.
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
1
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 post marketing 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 (OS) 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 (Sections 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, vou 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
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Indications for Use
510(k) Number (if known) K190490
Device Name VITROS XT Chemistry Products TRIG-CHOL Slides
Indications for Use (Describe) Rx Only For in vitro diagnostic use only
The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, or various endocrine disorders.
The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 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: K190490
Submitter's Information
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101 Phone: (585) 453-3475 Fax: (585) 453-3368
Contact Person
Alexandra Chamberlain, RAC Senior Regulatory Associate, Regulatory Affairs
Date of Preparation March 22, 2019
Device Proprietary Name(s)
VITROS XT Chemistry Products TRIG-CHOL Slides
Common Names
Triglyceride assay Cholesterol assay
Classification Names
| VITROS | Product Code | Class | Regulation Section | Panel |
|---|---|---|---|---|
| TRIG | CDT | Class I* | 21 CFR 862.1705 Triglyceride test | |
| system | Clinical | |||
| Chemistry | ||||
| CHOL | CHH | Class I* | 21 CFR 862.1175 Cholesterol | |
| (total) test system | (75) |
*Meet the limitations of exemptions per 21 CFR 862.9(c) (4) and will require a premarket notification because both analytes are used in assessing the risk of cardiovascular diseases.
Predicate Device(s)
| Predicate Devices | FDA 510(k) Number |
|---|---|
| VITROS Chemistry Products TRIG Slides | K130332 |
| VITROS Chemistry Products CHOL Slides | K820263 |
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Intended Use Statement(s) VITROS XT Chemistry Products TRIG-CHOL Slides Rx Only
For in vitro diagnostic use only
The TRIG test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
The CHOL test within the VITROS XT Chemistry Products TRIG-CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS XT 7600 Integrated Systems. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
Device Description
The new device, the VITROS XT Chemistry Products TRIG-CHOL Slide is a single device that contains both a TRIG test and a CHOL test multilayered, analytical elements coated on a polyester support 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.
To perform the TRIG test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence of L-a-glycerolphosphate oxidase, L-α-glycerophosphate is then oxidized to dihydrox vacetone phosphate and hydrogen peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce a dye. The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by reflectance spectrophotometry.
To perform the CHOL test, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye. The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance spectrophotometry.
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 TRIG-CHOL Slide | ||
| (New) | Predicate Devices | |
| VITROS TRIG Slide [K130332] | ||
| VITROS CHOL Slide [K820263] | ||
| (Current) | ||
| Intended Use | Same for each individual test | |
| For in vitro diagnostic use only. | For in vitro diagnostic use only. | |
| The TRIG test within the VITROS | ||
| XT Chemistry Products TRIG- | ||
| CHOL Slides quantitatively measure | ||
| triglyceride (TRIG) | ||
| concentration in serum and plasma. | VITROS Chemistry Products | |
| TRIG Slides quantitatively | ||
| measure triglyceride (TRIG) | ||
| concentration in serum and | ||
| plasma. | ||
| The CHOL test within the VITROS | ||
| XT Chemistry Products TRIG- | ||
| CHOL Slides quantitatively measure | ||
| cholesterol (CHOL) | ||
| concentration in serum and plasma. | VITROS Chemistry Products | |
| CHOL Slides quantitatively | ||
| measure cholesterol (CHOL) | ||
| concentration in serum and | ||
| plasma. | ||
| Device Description | No Change | Multilayered, analytical element |
| coated on a polyester support | ||
| Basic Principle | No Change | TRIG Colorimetric |
| CHOL Colorimetric | ||
| Incubation time and | ||
| temperature | No Change | Approximately 5 minutes |
| 37°C (98.6° F) | ||
| Sample type | No Change | Serum and plasma |
| Amount of Slide | ||
| Reactive Ingredients | ||
| per slide (test) | The composition of the analytical | |
| element of each test within the | ||
| VITROS XT Slide will remain the | ||
| same as that used in each predicate | ||
| devices | TRIG | |
| Lipase ( Pseudomonas sp.) 0.08 U; | ||
| peroxidase (horseradish root) 0.52 | ||
| U; glycerol kinase ( Cellulomonas | ||
| sp.) 0.35 U; L-a-glycerophosphate | ||
| oxidase ( Pediococcus sp.) 0.19 U; | ||
| Triton X-100 0.62 mg; 2-(3,5- | ||
| dimethoxy-4-hydroxyphenyl)-4,5- | ||
| bis(4-dimethylaminophenyl) | ||
| imidazole (leuco dye) 0.04 mg; | ||
| and adenosine triphosphate 0.14 | ||
| mg. | ||
| Summary of the technological characteristics of the device compared to the predicate device | ||
| Device Characteristic | New Device | |
| VITROS XT TRIG-CHOL Slide | ||
| (New) | Predicate Devices | |
| VITROS TRIG Slide [K130332] | ||
| VITROS CHOL Slide [K820263] | ||
| (Current) | ||
| CHOL | ||
| Triton X-100 0.81 mg; cholesterol | ||
| oxidase ( Cellulomonas sp.) 0.4 U; | ||
| cholesterol ester hydrolase | ||
| ( Pseudomonas sp.) 2.0 U; | ||
| peroxidase (horseradish root) 5.3 | ||
| U; and 2-(3,5-dimethoxy- 4- | ||
| hydroxyphenyl)-4,5-bis-(4- | ||
| dimethylaminophenyl) imidazole | ||
| (leuco dye) 0.17 mg. | ||
| Assay Range | No Change | TRIG 10.0-525.0 mg/dL |
| CHOL 50-325 mg/dL | ||
| Calibrators | Same | VITROS Chemistry Products |
| Calibrator Kit 2 | ||
| Controls | Same | VITROS Chemistry Products |
| 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 | ||
| Integrated Systems | ||
| Sample volume | TRIG 2.9 µL | |
| CHOL 3.9 µL | TRIG 5.5 µL | |
| CHOL 5.5 µL |
6
7
Non-Clinical Testing Analytical Performance
Method Comparison
Method Comparison testing followed CLSI Protocol EP09c, Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Serum samples were evaluated on the VITROS XT Chemistry Products TRIG-CHOL Slides using the VITROS XT 7600 Integrated System and on VITROS Chemistry Products TRIG Slides and VITROS Chemistry Products CHOL Slides using the VITROS 5600 Integrated System. The correlation between the predicate and the new tests within the VITROS XT TRIG-CHOL Slides on the VITROS XT 7600 Integrated System is summarized below.
Summary of Method Comparison Weighted Deming Regression Analysis Data Units mg/dL
| Test | N | Slope | Intercept | Corr.
Coeff. | Test Range | Measuring
range |
|------------|-----|-------|-----------|-----------------|------------|--------------------|
| TRIG Serum | 148 | 0.99 | 1.49 | 1.000 | 17 - 519 | 10 - 525 |
| CHOL Serum | 148 | 0.97 | 0.09 | 0.999 | 72 - 315 | 50 - 325 |
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 TRIG-CHOL 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. 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.
| TRIG Serum Units (mg/dL) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | Repeatability | Within Day | Within Lab | No. of | No. of | ||||
| Fluid Id | Conc. | SD | CV% | SD | CV% | SD | CV% | Obs. | Days |
| Pool 1 | 29 | 0.2 | 0.6 | 0.3 | 1.0 | 0.4 | 1.3 | 80 | 20 |
| Native Pool | 90 | 0.3 | 0.3 | 0.9 | 1.0 | 1.4 | 1.5 | 80 | 20 |
| Control 1 | 115 | 0.4 | 0.3 | 0.6 | 0.5 | 0.8 | 0.7 | 80 | 20 |
| Control 2 | 255 | 1.1 | 0.4 | 1.5 | 0.6 | 2.1 | 0.8 | 80 | 20 |
| Pool 2 | 379 | 1.4 | 0.4 | 2.3 | 0.6 | 3.4 | 0.9 | 80 | 20 |
| Pool 3 | 513 | 1.7 | 0.3 | 3.1 | 0.6 | 4.5 | 0.9 | 80 | 20 |
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| CHOL Serum Units (mg/dL) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean | Repeatability | Within Day | Within Lab | No. of | No. of | ||||
| Fluid Id | Conc. | SD | CV% | SD | CV% | SD | CV% | Obs. | Days |
| Pool 1 | 74 | 0.6 | 0.8 | 0.6 | 0.8 | 1.6 | 2.1 | 80 | 20 |
| Control 1 | 149 | 1.5 | 1.0 | 1.5 | 1.0 | 2.9 | 1.9 | 80 | 20 |
| Native Pool | 159 | 1.2 | 0.8 | 1.4 | 0.9 | 2.1 | 1.3 | 80 | 20 |
| Pool 2 | 208 | 1.5 | 0.7 | 2.1 | 1.0 | 3.1 | 1.5 | 80 | 20 |
| Control 2 | 261 | 1.5 | 0.6 | 2.5 | 1.0 | 4.2 | 1.6 | 80 | 20 |
| Pool 3 | 312 | 2.1 | 0.7 | 3.3 | 1.1 | 4.7 | 1.5 | 80 | 20 |
Detection Capability
Detection capability studies for the TRIG and CHOL tests within the VITROS XT TRIG-CHOL Slides were evaluated according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures.
The Limit of Quantitation (LoQ) for the TRIG test within the VITROS XT TRIG-CHOL Slides is 10 mg/dL. The total number of LoQ determinations was 180. The criteria used to accept the LoQ was %CV