(86 days)
Not Found
No
The summary describes a chemical reagent kit for quantitative measurement and does not mention any AI/ML components or functionalities.
No
Explanation: This device is an in vitro diagnostic (IVD) test, not a therapeutic device. It is used to quantitatively measure total calcium in human samples for diagnostic purposes (e.g., diagnosis and treatment of parathyroid diseases, chronic renal disease, and tetany), not to provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine" and that "Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany".
No
The device description clearly states it is a "kit only" consisting of a "mono-reagent R" with specific chemical components, indicating it is a chemical reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine..." This is the primary indicator of an IVD.
- Device Description: It describes a reagent kit used for testing biological samples (serum, plasma, urine).
- Intended User/Care Setting: It specifies "professional use and in vitro diagnostic use only."
- Performance Studies: The document details various performance studies (Precision, Linearity, Stability, Detection Limit, Interference, Method Comparison) which are typical for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a predicate device (K123171; HORIBA ABX ABX PENTRA CALCIUM AS CP) is common in regulatory submissions for IVDs, indicating a comparison to an already cleared device.
All these elements strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Product codes (comma separated list FDA assigned to the subject device)
CJY
Device Description
ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.
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
This device is intended for professional use and in vitro diagnostic use only. It is not intended for use in Point of Care settings.
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)
Precision/Reproducibility:
Study Protocol: CLSI EP05-A2 protocol (Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition).
Sample Size: 80 for each level (3 levels for Serum, 3 levels for Urine).
Key Results:
Serum Precision (%CV):
Level 1 (8.28 mg/dL): Within-run CV% 1.1, Total CV% 1.7
Level 2 (10.32 mg/dL): Within-run CV% 0.5, Total CV% 1.4
Level 3 (12.96 mg/dL): Within-run CV% 0.5, Total CV% 1.0
Urine Precision (%CV):
Level 1 (4.53 mg/dL): Within-run CV% 1.3, Total CV% 1.8
Level 2 (10.89 mg/dL): Within-run CV% 0.5, Total CV% 1.2
Level 3 (17.51 mg/dL): Within-run CV% 0.3, Total CV% 0.8
Linearity/Assay Reportable Range:
Study Protocol: CLSI protocol EP06-A (Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline).
Serum: 11 levels of concentration obtained by mixing high (15.35 mg/dL) and low (4.94 mg/dL) samples.
Urine: 11 levels of concentration obtained by mixing high (18.60 mg/dL) and low (1.45 mg/dL) samples.
Key Results:
Serum measuring range: 5.00 - 15.00 mg/dL.
Urine measuring range: 1.50 - 18.00 mg/dL.
Auto-dilution 1 to 5 allows for analyte activities up to 90.00 mg/dL.
Stability:
On-board Stability: Tested with 3 levels of sample (high/medium/low) in duplicate on ELITech Clinical Systems Selectra Pro M Analyzer.
Key Results: 28 days.
Real-time Stability: Followed for 24 months at 2-8°C on 3 different batches.
Detection Limit:
Study Protocol: CLSI protocol EP17-A (Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline).
Serum:
Limit of Detection: 0.04 mg/dL (from 15 measurements of 4 samples diluted with NaCl 0.9% to ~5 mg/dL).
Limit of Quantification: 5.00 mg/dL (from 15 measurements of 4 samples diluted with NaCl 0.9% to 5.0 mg/dL). Acceptance criteria: Total Error ≤ 0.32 mg/dL.
Urine:
Limit of Detection: 0.15 mg/dL (from 15 measurements of 4 samples diluted with NaCl 0.9% to 0.40 mg/dL).
Limit of Quantification: 1.50 mg/dL (from 15 measurements of 4 samples diluted with NaCl 0.9% to 1.50 mg/dL).
Interference/Analytical Specificity:
Study Protocol: CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).
Serum: Tested at 2 calcium levels (8.00 mg/dL and 12.00 mg/dL).
Interferents tested: Unconjugated bilirubin (up to 30.0 mg/dL), Conjugated bilirubin (up to 29.5 mg/dL), Hemoglobin (up to 500 mg/dL), Triglycerides (up to 3172 mg/dL), Magnesium (up to 12.2 mg/dL), Ascorbic acid (up to 20 mg/dL), Acetylsalicylic Acid (up to 200 mg/dL), Acetaminophen (up to 30 mg/dL).
Acceptance criteria: Bias of ±10%.
Key Results: No significant interference up to tested concentrations for all substances, except in very rare cases, monoclonal gammopathies (multiple myeloma), especially IgM type (Waldenstrom's macroglobulinemia), can cause unreliable results.
Urine: Tested at 2 calcium levels (4.00 mg/dL and 16.00 mg/dL).
Interferents tested: Conjugated bilirubin (up to 29.5 mg/dL), Hemoglobin (up to 500 mg/dL), Ascorbic acid (up to 20 mg/dL), Urea (up to 5000 mg/dL), Uric Acid (up to 100 mg/dL), Magnesium (up to 10 mg/dL), pH (2.5 to 12.0).
Acceptance criteria: Bias of ±10%.
Key Results: No significant interference up to tested concentrations for all substances, and for pH values ranging between 2.5 and 6.0.
Method Comparison:
Study Protocol: CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
Serum:
Sample Size: 106 serum patient samples (5.07 to 14.79 mg/dL).
Comparison: ELITech Clinical Systems CALCIUM ARSENAZO on Selectra ProM Analyzer vs. ABX Pentra Calcium AS CP on ABX Pentra analyzer.
Key Results: y = 0.949 x + 0.41 mg/dL, r = 0.993, r² = 0.986, Sy.x = 0.29 mg/dL.
Urine:
Sample Size: 52 urine patient samples (1.50 to 17.14 mg/dL).
Comparison: ELITech Clinical Systems CALCIUM ARSENAZO on Selectra ProM Analyzer vs. ABX Pentra Calcium AS CP on ABX Pentra analyzer.
Key Results: y = 0.936 x + 0.20 mg/dL, r = 0.995, r² = 0.990, Sy.x = 0.39 mg/dL.
Evaluation of Accuracy: Matrix Effect:
Study Protocol: CLSI protocol EP09-A2 (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
Sample Size: 63 paired serum and plasma patient specimens (lithium heparin samples, ranging from 5.19 to 14.38 mg/dL).
Comparison: Serum vs Plasma.
Key Results: y = 0.976x + 0.26 mg/dL, r = 1.000, r² = 0.993, Sy.x = 0.19 mg/dL.
Clinical Studies: Not applicable.
Clinical Cut-off: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Performance metrics provided are precision, linearity, detection limits, and interference for an in vitro diagnostic reagent.)
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
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. 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).(b)
Classification. Class II.
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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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2015
ELITECH GROUP DEBRA HUTSON VP RA/QA 21720 23RD DRIVE SE, SUITE 150 BOTHELL WA 98021
Re: K151113
Trade/Device Name: ELITech Clinical Systems CALCIUM ARSENAZO Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: II Product Code: CJY Dated: April 23, 2015 Received: April 27, 2015
Dear Debra Hutson:
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 (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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
Courtney H. Lias -S
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) K151113
Device Name
ELITech Clinical Systems CALCIUM ARSENAZO
Indications for Use (Describe)
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers.
It is not intended for use in Point of Care settings.
Calcium measurements are used in the diagnosis and treatment of parathyroid diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
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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3
510(k) Summary
ELITech Clinical Systems CALCIUM ARSENAZO
| 1. | Date: | April 23, 2015 |
|---|---|---|
| 2. | Submitter: | ELITech Clinical Systems SAS |
| Zone Industrielle | ||
| 61500 SEES | ||
| FRANCE | ||
| 3. | Contact Person: | Debra K. Hutson |
| VP RA/QA, EGI | ||
| 21720 23rd Dr SE, Suite 150 | ||
| Bothell, WA 98021 | ||
| Phone: 425-482-5174 | ||
| Fax: | ||
| 425-482-5550 | ||
| Email: d.hutson@elitechgroup.com | ||
| 4. | Device Name: | |
| Classification: | ELITech Clinical Systems CALCIUM ARSENAZO III | |
| Class II | ||
| CJY | ||
| Clinical Chemistry | ||
| 21 CFR 862.1145 | ||
| 5. | Predicate Device: | K123171 |
| HORIBA ABX | ||
| ABX PENTRA CALCIUM AS CP |
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- Intended Use:
ELITech Clinical Systems CALCIUM ARSENAZO is intended for the quantitative in vitro diagnostic determination of total calcium in human serum, plasma and urine using ELITech Clinical Systems Selectra Pro Series Analyzers. It is not intended for use in Point of Care settings. 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(s):
Rx only.
This device is intended for professional use and in vitro diagnostic use only. CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Special instrument requirements:
For use with ELITech Clinical Systems Selectra Pro Series Analyzers. Performance data was obtained on the Selectra ProM Analyzer.
7. Device Descriptions
ELITech Clinical Systems CALCIUM ARSENAZO is available as a kit only. It consists of a mono-reagent R whose composition is: 100 mmol/L MES buffer (pH 6.50), 200 µmol/L Arsenazo III.
8. Substantial Equivalence Information Assay (reagent)
-
- Predicate Device Name
- ABX PENTRA CALCIUM AS CP
-
- Comparison with predicate
Similarities
| Parameter | New Device
ELITech Clinical Systems
CALCIUM ARSENAZO | Predicate Device
ABX PENTRA CALCIUM AS CP,
K123171 |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ELITech Clinical Systems CALCIUM
ARSENAZO is intended for the
quantitative in vitro diagnostic
determination of total calcium in
human serum, plasma and urine using
ELITech Clinical Systems Selectra Pro
Series Analyzers.
It is not intended for use in Point of
Care settings. | ABX Pentra Calcium AS CP reagent,
with associated calibrator and controls,
is a diagnostic reagent for quantitative
in vitro determination of calcium in
human serum, plasma and urine based
on a colourimetric method, using the
ABX Pentra 400 Clinical Chemistry
analyzer. |
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| Parameter | New Device
ELITech Clinical Systems
CALCIUM ARSENAZO | Predicate Device
ABX PENTRA CALCIUM AS CP,
K123171 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | 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). | Measurements of calcium is used in the
diagnosis and treatment of parathyroid
disease, a variety of bone diseases,
chronic renal disease and tetany
(intermittent muscular contractions or
spasms). |
| Sample Type | Serum, Plasma, Urine | Same |
| Assay
Technology | Colorimetric test | Same |
| Composition | Reagent R:
MES Buffer, pH 6.50 100 mmol/L
Arsenazo III 200 μmol/L | Same |
| Appearance
of reagents | Liquid form, ready to use | Same |
Differences
| Parameter | New Device
ELITech Clinical Systems
CALCIUM ARSENAZO | Predicate Device
ABX PENTRA CALCIUM AS CP,
K123171 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Format | 12 x 20 mL | 1 x 79 mL |
| Storage &
Expiry | Store at 2-8°C and protect from light.
The reagent is stable until the expiry
date stated on the label. | Reagents, in unopened cassettes, are
stable up to the expiry date on the label
if stored at 2-8°C and contamination is
avoided. |
| Assay Range | Serum, Plasma : 5.00 - 15.00 mg/dL
Urine: 1.50 - 18.00 mg/dL | Serum, Plasma : 4.00 - 18.05 mg/dL
Urine: 0.64 - 18.05 mg/dL |
| Instrument | Selectra Pro M | ABX Pentra 400 |
| Reference
Values | Serum/ Plasma :
8.6 - 10.3 mg/dL
2.15 - 2.57 mmol/L
Urine (for a urinary volume of 1.5 L
per day) :
100 - 300 mg/24h
2.50 - 7.50 mmol/24h
Calcemia is always interpreted
according to the plasmatic protein
rates. | Serum / Plasma : 8.6 - 10.3 mg/dL
(2.15 - 2.57 mmol/L)
Urine :
Women: Unconjugated bilirubin: No
significant interference up to
30.0 mg/dL (513 µmol/L).
Conjugated bilirubin: No significant
interference up to 29.5 mg/dL (504
µmol/L).
Hemoglobin: No significant
interference up to 500 mg/dL.
Triglycerides: No significant
interference up to 1726 mg/dL.
Magnesium: No significant
interference up to 12.0 mg/dL
Ascorbic acid: No significant
interference up to 20.0 mg/dL.
Acetylsalicylic Acid: No significant
interference up to 200 mg/dL.
Acetaminophen: No significant
interference up to 30 mg/dL. | Total Bilirubin: No significant influence
is observed up to 788 µmol/L
(46.1 mg/dL).
Direct Bilirubin: No significant
influence is observed up to 445 µmol/L
(26.0 mg/dL).
Haemoglobin: No significant influence
is observed up to 290 µmol/L (500
mg/dL).
Lipemia: No significant influence is
observed up to an Intralipid®
concentration (representative of
lipemia) of 500 mg/dL.
Magnesium: No significant influence is
observed up to 4.42 mmol/L (10.7
mg/dL).
Ascorbic Acid: No significant influence
is observed up to 3.40 mmol/L (60
mg/dL).
Acetylsalicylic Acid: No significant
influence is observed up to 3.62 mmol/L
(65.2 mg/dL).
Acetaminophen: No significant
influence is observed up to 1324 µmol/L
(20 mg/dL).
Ibuprofen: No significant influence is
observed up to 2.42 mmol/L (50.1
mg/dL). |
| Parameter | New Device
ELITech Clinical Systems
CALCIUM ARSENAZO | Predicate Device
ABX PENTRA CALCIUM AS CP,
K123171 |
| Interferences -
Urine | Conjugated bilirubin: No significant
interference up to 29.5 mg/dL (504
μmol/L).
Hemoglobin: No significant
interference up to 500 mg/dL
Ascorbic acid: No significant
interference up to 20.0 mg/dL.
Urea: No significant interference up
to 5000 mg/dL.
Uric Acid: No significant interference
up to 100 mg/dL.
Magnesium: No significant
interference up to 10.0 mg/dL
pH: No significant interference for pH
values ranging between 2.5 and 6.0. | Direct Bilirubin: No significant
influence is observed up to 432 μmol/L
(25.3 mg/dL).
Haemoglobin: No significant influence
is observed up to 290 μmol/L (500
mg/dL).
Ascorbic Acid: No significant influence
is observed up to 3.40 mmol/L (60
mg/dL).
Lipemia: No significant influence is
observed up to an Intralipid®
concentration (representative of
lipemia) of 200 mg/dL.
Magnesium: No significant influence is
observed up to 5.34 mmol/L (13.0
mg/dL).
pH: The urine should not be alkalinized. |
| On-board
stability | 28 days | 60 days |
| Calibration
frequency | Calibration frequency: 28 days
Recalibrate when reagent lots
change, when quality control results
fall outside the established range,
and after a maintenance operation. | The reagent is calibrated on Day 0. The
calibration stability is checked by
testing 2 control specimens.
The calibration stability is 10 days.
Note: A recalibration is recommended
when reagent lots change, and when
quality control results fall outside the
range established. |
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7
9. Standard/Guidance Document Reference
No applicable mandatory performance standards or special controls exist for this device
10. Test Principle:
Arsenazo III [2,7-(bis(2-arsonophenylazo))-1,8-dihydroxynaphtalene-3,6-disulphonic acid], forms in neutral medium a blue complex with calcium. The color intensity is directly proportional to the total calcium concentration.
Performance Characteristics - Analytical Performance 11.
a. Precision/Reproducibility
Precision
The precision of the device was determined in accordance with 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 3 levels of samples on 2 instruments during twenty operating days
8
according to CLSI EP05-A2 protocol. The results are presented in the table below:
Serum
| Level | n | Mean (mg/dL) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 8.28 | 1.1 | 1.7 |
| Level 2 | 80 | 10.32 | 0.5 | 1.4 |
| Level 3 | 80 | 12.96 | 0.5 | 1.0 |
Urine
| Level | n | Mean (mg/dL) | Precision % | |
|---|---|---|---|---|
| Within-run CV% | Total CV% | |||
| Level 1 | 80 | 4.53 | 1.3 | 1.8 |
| Level 2 | 80 | 10.89 | 0.5 | 1.2 |
| Level 3 | 80 | 17.51 | 0.3 | 0.8 |
b. Linearity/assay reportable range
The linearity study of ELITech Clinical Systems CALCIUM ARSENAZO 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 CALCIUM ARSENAZO was studied by mixing a sample with high value (15.35 mg/dL) and a sample with low value (4.94 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the Calcium concentration of each of the 11 levels using ECS Calcium Arsenazo reagent.
From this study, a measuring range from 5.00 - 15.00 mg/dL has been determined.
Urine:
The linearity of ELITech Clinical Systems CALCIUM ARSENAZO was studied by mixing a sample with high value (18.60 mg/dL) and a sample with low value (1.45 mg/dL) to obtain 11 levels with equidistant concentrations and then measuring the Calcium concentration of each of the 11 levels using ECS Calcium Arsenazo reagent.
From this study, a measuring range from 1.50 - 18.00 mg/dL has been determined.
Auto-dilution 1 to 5 allows the use of the ELITech Clinical Systems CALCIUM ARSENAZO with analyte activities up to 90.00 mg/dL.
c. Traceability
For calibration, a multi-parametric calibrator, most recently cleared under K132399, 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 calcium value assigned to calibrate ELITech Clinical Systems CALCIUM ARSENAZO, is included in its labeling. Traceability for calcium is to NIST SRM 956c Quality Control Materials.
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d. Stability
On board stability:
This evaluates the period of time during which correct measurements are obtained after installation of a new vial on board.
At least 3 levels of sample (high/medium/low) are tested in duplicate at Day 0 (D0).
At regular intervals, the three (3) concentration levels are analyzed in duplicate, until the deviations from the results at DO are higher than acceptance criteria or for at least 30 days. During this period, the reagents are stored on the analyzer (vial open).
This study was performed on one (1) lot of ELITech Clinical Systems CALCIUM ARSENAZO reagent on ELITech Clinical Systems Selectra Pro M Analyzer. Results indicate the on-board stability of the reagent is 28 days.
Real-time stability:
The shelf-life of ELITech Clinical Systems CALCIUM ARSENAZO reagent has been followed in real time for 24 months at 2-8°C on 3 different batches.
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 CALCIUM ARSENAZO and diluted with NaCl 0.9% to obtain a concentration of approximately 5 mg/dL.
The data are not Gaussian, so LoD= LoB + Dsg (where Ds & is determined by calculating the median minus the 50 percentile of the low concentration sample distribution).
Limit of Detection = 0.04 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 CALCIUM ARSENAZO 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 CALCIUM ARSENAZO and diluted with NaCl 0.9% to obtain a concentration of 0.40 mg/dL.
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The data are not Gaussian, so LoD= LoB + Dsg (where Dsg is determined by calculating the median minus the 5th percentile of the low concentration sample distribution).
Limit of Detection = 0.15 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 CALCIUM ARSENAZO and diluted with NaCI 0.9% to obtain a concentration of 1.50 mg/dL.
Limit of Quantification =1.50 mg/dL.
f. Interference/analytical specificity
Serum
Interferences due to unconjugated bilirubin, conjugated bilirubin, hemoglobin, triglycerides, magnesium, ascorbic acid, acetylsalicylic acid and acetaminophen were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline - Second Edition).
For each potential interferent tested, 2 serum sample pools at two calcium levels close to those specified in Appendix B of EP7-A2 were prepared:
-1 pool: low concentration at nominal 8.00 mq/dL
-200 pool: high concentration at nominal 12.00 mg/dL
-200 pool: high concentration at nominal 12.00 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 |
|------------------------|------------------|----------------------------------------------|
| 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 |
| Triglycerides | up to 3172 mg/dL | 8 |
| Magnesium | up to 12.2 mg/dL | 8 |
| Ascorbic acid | up to 20 mg/dL | 7 |
| Acetylsalicylic Acid | up to 200 mg/dL | 7 |
| 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 (8.00 mg/dL) or high (12.00 mg/dL) nominal concentration.
The results of testing interferences are the following:
- i Concentration up to 30.0 mg/dL unconjugated bilirubin, 29.5 mg/dL conjugated bilirubin, 500 mg/dL hemoglobin, 1726 mg/dL triglycerides, 12.0 mg/dL magnesium, 20.0 mg/dL ascorbic acid, 200 mg/dL acetylsalicylic acid 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
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type (Waldenstrom's macroglobulinemia) can cause unreliable results.
The following statement will also be included in the labeling:
Other compounds may interfere. Users should refer to the three following literature references:
-Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 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, Ascorbic acid, Urea, Uric Acid, Magnesium, and pH were investigated following the recommended sample levels in CLSI EP07-A2 protocol (Interference Testing in Clinical Chemistry; Approved Guideline -Second Edition).
For each potential interferent tested, 2 urine sample pools at two calcium levels close to those specified in Appendix B of EP7-A2 were prepared:
-1 $ pool: low concentration at nominal 4.00 mg/dL
-200 pool: high concentration at nominal 16.00 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 |
|----------------------|------------------|----------------------------------------------|
| Conjugated bilirubin | up to 29.5 mg/dL | 7 |
| Hemoglobin | up to 500 mg/dL | 9 |
| Ascorbic acid | up to 20 mg/dL | 7 |
| Urea | up to 5000 mg/dL | 6 |
| Uric Acid | up to 100 mg/dL | 6 |
| Magnesium | up to 10 mg/dL | 8 |
| pH | 2.5 to 12.0 | 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 (4.00 mg/dL) or high (16.00 mg/dL) nominal concentration.
The results of testing interferences are the following:
- Concentration up to 29.5 mg/dL conjugated bilirubin, 500 mg/dL hemoglobin, 10.0 mg/dL magnesium, 20.0 mg/dL ascorbic acid, 5000 mg/dL urea, 100 mg/dL uric acid, and pH values ranging between 2.5 and 6.0 do not show any significant interference for each substance.
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The following statement will also be included in the labeling:
Other compounds may interfere. Users should refer to the two following literature references: -Young, D. S., Effects of preanalytical variables on clinical laboratory tests, 200 Ed., AACC Press, (1997). -Young, D. S., Effects of drugs on clinical laboratory tests, 40 Ed., AACC Press, (1995).
11. Performance Characteristics - Comparison Studies
a. Method comparison
Serum
A correlation study was performed between ELITech Clinical Systems CALCIUM ARSENAZO reagent on a Selectra ProM Analyzer and ABX Pentra Calcium AS CP reagent on a ABX Pentra analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition).
This study was performed using 106 serum patient samples from 5.07 to 14.79 mg/dL over a span of 5 days.
Regression analysis of the results yielded the following: y = 0.949 x + 0.41 mg/dL. r = 0.993 r² = 0.986 Standard error of the estimate Sy.x = 0.29 mg/dL.
Urine
A correlation study was performed between ELITech Clinical Systems CALCIUM ARSENAZO reagent on a Selectra ProM Analyzer and ABX Pentra Calcium AS CP reagent on a ABX Pentra analyzer according to CLSI EP09-A2 protocol (Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline - Second edition)
This study was performed using 52 urine patient samples from 1.50 to 17.14 mg/dL over a span of 5 days.
Regression analysis of the results yielded the following: y = 0.936 x + 0.20 mg/dL r = 0.995 r2 = 0.990 Standard error of the estimate Sy.x = 0.39 mg/dL
b. Evaluation of Accuracy: Matrix Effect
63 paired serum and plasma patient specimens (in lithium heparin samples, ranqing from 5.19 to 14.38 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 vielded the following:
y = 0.976x + 0.26 mg/dL r = 1.000 r² = 0.993
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Standard error of the estimate Sy.x = 0.19 mg/dL
c. Expected values/Reference Range
As indicated in the instructions for use for ELITech Clinical Systems CALCIUM ARSENAZO, each laboratory should establish and maintain its own reference values. The values given are used as guidelines only.
Serum/ Plasma-:
8.6 - 10.3 mg/dL 2.15 - 2.57 mmol/L
Urine (for a urinary volume of 1.5 L per day) : 100 – 300 mg/24h 2.50 – 7.50 mmol/24h
Calcemia is always interpreted according to the plasmatic protein rates.
These reference values are from:
Wu, A.H.B., Tietz Clinical guide to laboratory tests, 4 th Ed., (W.B. Saunders), (2006), 684.
2 Endres D.B., Rude R.K., Disorders of Bone, Tietz Fundamentals of Clinical Chemistry, 6th ED., Burtis, C.A. & Ashwood, E.R., Bruns.D.E., (Saunders), (2008), 711.
d. Clinical Studies:
Not applicable
e. Clinical Cut-off:
Not applicable
12. Conclusion
The information on the principle and performance of our device that is contained in this premarket notification is complete and supports a decision that our device is substantially equivalent to the predicate device.