(261 days)
Not Found
No
The device description and performance studies focus on chemical reagents and analytical performance metrics typical of in vitro diagnostic assays, with no mention of AI/ML or related concepts like algorithms, training data, or image processing.
No.
The device is described as an "in vitro diagnostic determination of glucose," which is used for diagnosis and treatment of conditions, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative in vitro diagnostic determination of glucose" and that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders".
No
The device description explicitly states it is a kit consisting of chemical reagents (Bi-reagent R1 & R2) and calibrator/control materials, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the ELITech Clinical Systems GLUCOSE HK SL is "intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine." It also mentions that the calibrator (ELICAL 2) and control sera (ELITROL II) are for "in vitro diagnostic use."
- Device Description: The description details the composition of the reagents, calibrator, and control materials, which are all components used in an in vitro diagnostic test.
- Intended User/Care Setting: While it specifies "Prescription Use" and "not intended for use in Point of Care settings," this still aligns with the use of IVDs in clinical laboratory settings.
- Performance Studies: The document describes various performance studies (Precision/Reproducibility, Linearity, Traceability, Stability, Detection limit, Interference, Method comparison, Matrix comparison) that are typical for evaluating the performance of an IVD.
- Predicate Device(s): The mention of predicate devices with K numbers (which are FDA clearance numbers for medical devices, including IVDs) further confirms its classification as a medical device, specifically an IVD given the context.
The core function of the device is to perform a test on biological samples (serum, plasma, urine) outside of the body ("in vitro") to provide diagnostic information (glucose levels for diagnosing and treating carbohydrate metabolism disorders). This directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
ELITech Clinical Systems ELITROL I and ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
Product codes (comma separated list FDA assigned to the subject device)
CFR, JIX, JJY
Device Description
ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
ELITECHGROUP TERRY TRIMINGHAM REGULATORY ASSOCIATE 21720 23RD DRIVE SE, SUITE 150 BOTHELL, WA 98021
Re: K153644 Trade/Device Name: ELITech Clinical Systems GLUCOSE HK SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I ELITech Clinical Systems ELITROL II Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II
Product Code: CFR, JIX, JJY Dated: July 25, 2016 Received: July 26, 2016
Dear Terry Trimingham:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -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) K153644
Device Name
ELITech Clinical Systems GLUCOSE HK SL ELITech Clinical Systems ELICAL 2 ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
Indications for Use (Describe)
ELITech Clinical Systems GLUCOSE HK SL is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia, and of pancreatic diseases.
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
ELITech Clinical Systems ELITROL II are multiparametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Analyzers.
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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K153644
510(k) Summary Submitted in accordance with CFR 807.92
ELITech Clinical Systems GLUCOSE HK SL
| 1. | Date: | August 16, 2016 |
|---|---|---|
| 2. | Submitter: | ELITech Clinical Systems SAS |
| Zone Industrielle | ||
| 61500 SEES | ||
| FRANCE | ||
| 3. | Contact Person: | Terry Trimingham |
| 21720 23rd Dr SE, Suite 150 | ||
| Bothell, WA 98021 | ||
| Phone: 425-482-5190 | ||
| Fax: 425-482-5550 | ||
| Email: t.trimingham@elitechgroup.com | ||
| 4. | Device Description: | |
| Classification | ELITech Clinical Systems GLUCOSE HK SL | |
| Class II | ||
| CFR Glucose HK | ||
| Clinical Chemistry | ||
| 21 CFR 862.1345 | ||
| Device Description: | ||
| Classification | ELITech Clinical Systems ELICAL 2 | |
| Class II | ||
| JIX | ||
| Clinical Chemistry | ||
| 21 CFR 862.1150 | ||
| Device Description: | ||
| Classification | ELITech Clinical Systems ELITROL I and ELITROL II | |
| Class I | ||
| JJY | ||
| Clinical Chemistry | ||
| 21 CFR 826.1660 | ||
| 5. | Predicate Device: | K951595 |
| Roche Diagnostics | ||
| Cobas C111 Glucose HK |
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6. Intended Use
| Reagent: | ELITech Clinical Systems GLUCOSE HK SL is intended
for the quantitative in vitro diagnostic determination of
glucose in human serum, plasma and urine on ELITech
Clinical Systems Selectra Pro Series Analyzers. Glucose
measurements are used in the diagnosis and treatment of
carbohydrate metabolism disorders including diabetes
mellitus and idiopathic hypoglycemia, and of pancreatic
diseases. |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibrators: | ELITech Clinical Systems ELICAL 2 is a multi-parametric
calibrator for in vitro diagnostic use in the calibration of
quantitative ELITech Clinical Systems methods on
ELITech Clinical Systems Analyzers. |
| Controls: | ELITech Clinical Systems ELITROL I and ELITROL II are
multiparametric control sera for in vitro diagnostic use in
quality control of quantitative ELITech Clinical Systems
methods on ELITech Clinical Systems Analyzers. |
Special conditions for use statement(s):
This device is intended for prescription use and in vitro diagnostic only.
CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner. It is not intended for use in Point of Care settings.
Reagent Special instrument requirements:
For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM Analyzer.
Device Descriptions 7.
ELITech Clinical Systems GLUCOSE HK SL is available as a kit only. It consists of a Bi-reagent R1 & R2 whose composition is: R1: Pipes buffer, pH 7.60 80 mmol/L, NAD 4.1 mmol/L, ATP 2.2 mmol/L, Sodium azide in vitro
diagnostic use in the calibration of
quantitative ELITech Clinical Systems
methods on ELITech Clinical Systems
Analyzers. | Calibrator for automated systems
(C.f.a.s.) is for use in the calibration of
quantitative Roche methods on Roche
clinical chemistry analyzers as
specified in the value sheets. |
| Format | Lyophilized calibrator based on human
serum with constituents added as
requires to obtain desired component
levels | Same |
| Level | Single Level | Same |
| Stability | Lyophilized:
To store at 2-8°C and protected from
light until the expiry date
After reconstitution, the stabilities are:
- 8 hours between 15-25 °C.
- 2 days between 2-8 °C.
- 4 weeks between -25 and -15 °C (when
frozen once) | Same |
9. Standard/Guidance Document Reference
- CLSI EP5-A2 (Evaluation of precision performance of Quantitative . MeasurementMethods: Approved Guideline - Second Edition). CLSI protocol EP6-A (Evaluation of the Linearity of Quantitative Measurement Procedure: A Statistical Approach; Approved Guideline).
- CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
- . CLSI protocol EP7-A2 (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition) used for recommended sample concentrations.
- CLSI protocol EP9-A2 (Method Comparison and Bias Estimation Using Patient . Samples ; Approved Guideline - Second edition).
- . NF EN 13640:2002 "Stability testing of in vitro diagnostic reagents
- Test Principle: 10.
The reaction of glucose with ATP produces Glucose –6-phosphate which in presence of NAD+ will produce D-Gluconate-6-phosphate + NADH + H*
The increase of absorbance is directly proportional to the glucose concentration.
Performance Characteristics - Analytical Performance 11.
a. Precision/Reproducibility
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Precision
The precision of the device was determined in accordance to CLSI EP05-A2 protocol (Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition).
Within-run and total precision results were obtained by performing two runs per day, two measures per run, for 4 levels of samples on 2 instruments during twenty operating days according to CLSI EP05-A2 protocol. The results are presented in the table below:
| Level | n | Mean (mg/dL) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 45.5 | 1.1 | 2.0 |
| Level 2 | 80 | 119.5 | 0.9 | 1.7 |
| Level 3 | 80 | 251.5 | 0.9 | 2.0 |
| Level 4 | 80 | 522.5 | 0.4 | 1.8 |
Serum Level 1,2 and 4 are human sera, level 3 is a control sera
Urine
Level 1 ,2 and 3 are urine pool
| Level | n | Mean (mg/dL) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 18.0 | 0.9 | 2.0 |
| Level 2 | 80 | 204.4 | 0.7 | 1.7 |
| Level 3 | 80 | 497.4 | 0.6 | 1.7 |
b. Linearity/assay reportable range
The linearity study of ELITech Clinical Systems GLUCOSE HK SL was performed according to CLSI protocol EP06-A (Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline).
Serum:
The linearity of ELITech Clinical Systems GLUCOSE HK SL was studied by mixing a sample with high value (726.6 mg/dL) and a sample with low value (20.0 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the glucose concentration of each of the 11 levels using ECS GLUCOSE HK SL reagent.
Regression analysis of the results yielded the following: y = 1.025x - 2.0 mg/dL. r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 2.0 mg/dL
From this study, a measuring range from 20 - 720 mg/dL has been determined.
10
Urine:
The linearity of ELITech Clinical Systems GLUCOSE HK SL was studied by mixing a sample with high value (724.9 mg/dL) and a sample with low value (10.1 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the glucose concentration of each of the 11 levels using ECS GLUCOSE HK SL reagent.
Regression analysis of the results yielded the following: y = 1.0155x - 1.6 mg/dL. r = 0.999 r2 = 0.998 Standard error of the estimate Sy.x = 3.5 mg/dL
From this study, a measuring range from 10 - 720 mg/dL has been determined.
Auto-dilution 1 to 5 allows the use of the ELITech Clinical Systems GLUCOSE HK SL with analyte activities up to 3600 mg/dL.
c. Traceability
For calibration, a multi-parametric calibrator, most recently cleared under K151552, named ELITech Clinical Systems ELICAL 2 (manufactured by ELITech Clinical Systems SAS under product code CALI-0580) must be used. Traceability of the assigned value for all constituents in this calibrator, including the qlucose value assigned to calibrate ELITech Clinical Systems GLUCOSE HK SL. is included in its labeling. ELITech Glucose Hexokinase method is traceable to Isotope-dilution/Mass spectrometry, validated through the testing of SRM 965b of National Institute of Standards and Technology (NIST).
d. Stability
On board stability for the ELITech Clinical Systems GLUCOSE HK SL was established by real time studies on the ELITech Clinical Systems Selectra ProM Analyzer. The on-board stability of the reagent is 28 days. The shelf-life of GLUCOSE HK SL reagent has been followed in real time for 36 months on 3 different batches; a real-time stability of 27 months is claimed.
Serum control material is purchased from a commercial vendor (previously cleared under K041227). The following is claimed for stability: Before reconstitution, the shelf-life of the ELITech Clinical Systems ELITROL I and ELITROL II is 24 months at 2-8°C. After reconstitution the stability is 12 hours when stored at 15-25°C, 5 days when stored at 2-8°C or 4 weeks (when frozen once) at -25° and -15° C.
Calibrator material is purchased from a commercial vendor (previously cleared under K033501). The following is claimed for stability: Before reconstitution, the shelf-life of ELITech Clinical Systems Elical 2 is stable 24 months at 2-8°C. After reconstitution the stability is 8 hours when stored at 15-25°C, 2 days at 2-8°C or 4 weeks (when frozen once) at -25°and -15°C. The labeling states that the Elical 2 should be stored tightly capped and protected from light when not in use.
Value Assignment
Elitrol I and II are value assigned using multiple ELITech Clinical Systems Selectra ProM Series Analyzers. Each sample is tested in triplicate over several days. The target value of Level I and II are the median of the observed values range. After validation of the target value, a confidence range (high and low values) is then calculated.
Elical 2 is tested against predetermined values on one ELITech Clinical Systems Selectra ProM Series Analyzers using the GLUCOSE HK SL reagent and 2 levels of quality control material. The mean analyte value is calculated and a target value is assigned.
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e. Detection limit
Determined according to CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
Serum
Limit of Detection:
The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCI 0.9% to obtain a concentration of approximately 5 mg/dL.
The data are not Gaussian, so LoD= LoB + Dsg (where Dsg is determined by calculating the median minus the 5th percentile of the low activity sample distribution).
Limit of Detection = 0.3 mg/dL.
Limit of Quantification:
The limit of Quantification was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 5.0 mg/dL.
Acceptance criteria: The acceptable Total Error for the determination Limit of Quantification is ≤ 0.32 mg/dL. If the confidence Interval is within the acceptable total error limits, then the Limit of Quantification is acceptable. The value must be equal or higher than the Limit of Detection.
Limit of Quantification = 5.00 mg/dL.
Urine
Limit of Detection:
The limit of Detection was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 5.0 mg/dL.
The data are not Gaussian, so LoD= LoB + Ds (where Ds & is determined by calculating the median minus the 5th percentile of the low activity sample distribution).
Limit of Detection = 0.2 mg/dL.
Limit of Quantification
The limit of Quantification was obtained from 15 measurements of 4 samples prepared from 4 patient samples measured using ELITech Clinical Systems GLUCOSE HK SL and diluted with NaCl 0.9% to obtain a concentration of 1.50 mg/dL.
Acceptance criteria: The acceptable Total Error for the determination Limit of Quantification is ≤ 0.8 mg/dL. If the confidence Interval is within the acceptable total error limits, then the Limit of Quantification is acceptable. The value must be equal or higher than the Limit of Detection.
Limit of Quantification =5.00 mg/dL.
f. Interference/analytical specificity
Serum
Interferences due to unconjugated bilirubin, conjugated bilirubin, hemoglobin, triglycerides, ascorbic acid, uric acid, methyl dopa, L-dopa, Tolazamide and acetaminophen were investigated following the recommended sample levels in CLSI EP07-A2 protocol
12
(Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).
For each potential interferent tested, 2 serum sample pools at two glucose levels close to those specified in Appendix B of EP7-A2 we
-1* pool: low activity at nominal 50.0 mg/d
-200 pool: high activity at nominal 120.0 mg/ those specified in Appendix B of EP7-A2 were prepared:
- 1st pool: low activity at nominal 50.0 mg/dL
pool: high activity at nominal 120.0 mg/dL
Aliquots of each of the serum sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.
| Interferent | Test range | Number of different
concentrations tested |
|------------------------|------------------|----------------------------------------------|
| Triglycerides | up to 3000 mg/dL | 9 |
| Unconjugated bilirubin | up to 30.0 mg/dL | 7 |
| Conjugated bilirubin | up to 29.5 mg/dL | 7 |
| Hemoglobin | up to 500 mg/dL | 9 |
| Uric acid | up to 20.0 mg/dL | 7 |
| L-dopa | up to 30 mg/dL | 7 |
| Ascorbic acid | up to 20 mg/dL | 7 |
| Methyl dopa | up to 2.0 mg/dL | 6 |
| Tolazamide | up to 50 mg/dL | 6 |
| Acetaminophen | up to 30 mg/dL | 7 |
Two (2) levels of control (Serum control Level 1 (ELITROL I) and Serum control Level 2 (ELITROL II)) were tested to check the calibration.
For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (50.0 mg/dL) or high (120.0 mg/dL) nominal activity.
The results of testing interferences are the following:
- Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL conjugated bilirubin, -500 mg/dL hemoglobin, 600 mg/dL triglycerides (At a level of ~1300mg/dL of Triglycerides, a negative bias of 32% is observed at 50 mg/dL of glucose, and a negative bias of 19% is observed at 120mg/dL of glucose), 20.0 mg/dL ascorbic acid, 20.0 mg/dL uric acid. 2.0 mg/dL methyl dopa, 30.0 Tolazamide and 30 mg/dL acetaminophen do not show any significant interference for each substance.
- In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom's macroglobulinemia) can cause unreliable results.
The following statement will also be included in the labeling:
Many other substances and drugs may interfere. Some of them are listed in Young. -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 20° Ed., AACC Press, (1997).
- Young, D. S., Effects of drugs on clinical laboratory tests, 4th Ed., AACC Press, (1995). -Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of literature, Acta Clin Belg., (2004), 59, 263.
Urine
Interferences due to Conjugated bilirubin, Hemoglobin, Uric Acid and Urea were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition). Also tested were pH and specific gravity.
13
For each potential interferent tested, 2 urine sample pools at two glucose levels close to those specified in Appendix B of EP7-A2 were prepared:
- -18t pool: low activity at nominal 18.0 mg/dL
-20d pool: high activity at nominal 200.0 mg/dL
Aliquots of each of the urine sample pools were spiked with increasing interferent concentration. Test ranges covered at least the interferent level specified in Appendix D of EP7-A2. Thus, there were two series of interferent spike for each potential interferent tested. A control sample was prepared from the sample pool diluted in the appropriate diluent.
| Interferent | Test range | Number of different
concentrations tested |
|----------------------|------------------------|----------------------------------------------|
| Conjugated bilirubin | up to 29.5 mg/dL | 7 |
| Hemoglobin | up to 500 mg/dL | 9 |
| Uric acid | up to 100 mg/dL | 6 |
| Urea | up to 6000 mg/dL | 6 |
| pH | between 2.5 to 12.0 | 7 |
| Specific Gravity | between 1.000 to 1.030 | 6 |
Two (2) levels of control (Serum control Level 1 (ELITROL I) and Serum control Level 2 (ELITROL II)) were tested to check the reagents.
For both sample pools for each interferent, each point was measured in triplicate per run. Acceptance criteria: an accepted bias of ±10% in sample pools with low (18.0 mg/dL) or high (200.0 mg/dL) nominal activity.
The results of testing interferences are the following:
- Concentration up to 29.5 mg/dL conjugated bilirubin, 500 mg/dL hemoglobin, 100 mg/dL uric acid and 6000 mg/dL urea do not significant interference for each substance.
The following statement will also be included in the labeling:
Many other substances and drugs may interfere. Some of them are listed in Young. -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 20° Ed., AACC Press, (1997).
-Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995).
Performance Characteristics - Comparison Studies 11.
a. Method comparison
Serum
A correlation study was performed between ELITech Clinical Systems GLUCOSE HK SL reagent on a Selectra ProM Analyzer and GLUC2 (Glucose HK) reagent on Cobas C111 analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
This study was performed using 100 serum patient samples from 20.5 to 707.5 mg/dL over a span of 5 days.
Regression analysis of the results vielded the following: v = 1.008 x + 0.4 ma/dL. r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 2.7 mg/dL.
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Urine
A correlation study was performed between ELITech Clinical Systems GLUCOSE HK SL reagent on a Selectra ProM Analyzer and GLUC2 (Glucose HK) reagent on Cobas C111 analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition)
This study was performed using 40 urine patient samples (with glacial acetic acid as preservative) from 10.1 to 703.9 mg/dL over a span of 2 days.
Regression analysis of the results yielded the following: y = 0.996 x - 0.4 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 3.5 mg/dL
b. Comparison study: Matrix comparison
40 plasma patients (in lithium heparin samples, ranging from 24.3 to 710.1 mg/dL), were tested on ELITech Clinical Systems Selectra ProM Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
Regression analysis of the results yielded the following:
y = 1.001x - 0.7 mg/dL r = 1.000 r2 = 1.000 Standard error of the estimate Sy.x = 1.9 mg/dL
40 plasma patients (in sodium fluoride/ oxalate, ranging from 21.2 to 701.4 mg/dL), were tested on ELITech Clinical Systems Selectra ProM Analyzer according to CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
Regression analysis of the results yielded the following:
y = 1.016x - 0.9 mg/dL r = 0.999 r2 = 0.998 Standard error of the estimate Sy.x = 7.0 mg/dL
c. Expected values/Reference Range
As indicated in the instructions for use for ELITech Clinical Systems GLUCOSE HK SL, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.
Serum/ Plasma :
74 - 106 mg/dL 4.1 – 5.9 mmol/L