(68 days)
The Yumizen C1200 Glucose HK reagent is intended for the quantitative in vitro diagnostic determination of gluose in human serum, plasma, and urine using a glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
The sodium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The sodium electrode is used to quantify the concentrations of sodium ions in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The potassium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The potassium electrode is used to quantify the concentrations of potassium ions in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
The chloride electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is used to quantify the concentrations of chloride ions in serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Yumizen C1200 is an automatic chemistry analyzer that measures in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use.
The Yumizen C1200 is an automatic chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use. The system includes the Yumizen C1200 Glucose HK reagent, Sodium Electrode, Potassium Electrode, and Chloride Electrode. The analyzer uses photometric measurement and ion selective electrodes.
Here's a breakdown of the acceptance criteria and study information for the Horiba Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, and Chloride Electrode, based on the provided FDA 510(k) summary:
Horiba Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly met by demonstrating substantial equivalence to predicate devices and acceptable performance within the established ranges. The performance metrics are reported.
Yumizen C1200 Glucose HK:
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Measuring Range | Appropriateness of claimed ranges based on CLSI guideline EP17-A2 (Limit of Detection, Quantitation) & EP06-A (Linearity) | Serum/Plasma: Limit of Quantitation: 1.8 mg/dL (0.10 mmol/L); Measuring Range: 1.8 to 630.0 mg/dL (0.10 to 35.00 mmol/L) Urine: Limit of Quantitation: 3.5 mg/dL (0.19 mmol/L); Measuring Range: 8.5 to 630.0 mg/dL (0.47 to 35.00 mmol/L) Post-dilution: Up to 2520.0 mg/dL (140.00 mmol/L) in serum/plasma/urine |
| Repeatability (within-run precision) | Acceptable CV% | Serum: Control N: 1.1% (CV), Control P: 0.7% (CV), Samples 1-5: 0.5-1.1% (CV) Urine: Control N: 0.5% (CV), Control P: 0.6% (CV), Samples 1-5: 0.5-1.0% (CV) |
| Reproducibility (total precision) | Acceptable CV% (CLSI guideline EP05-A3) | Serum: Control N: 1.5% (CV), Control P: 1.4% (CV), Samples 1-5: 1.6-2.3% (CV) Urine: Control N: 4.0% (CV), Control P: 3.0% (CV), Samples 1-5: 3.2-4.3% (CV) |
| Interferences | Calculated bias within 10% | Serum: Hemoglobin (501 mg/dL), Triglycerides (569 mg/dL), Total Bilirubin (35.53 mg/dL), Direct Bilirubin (21.09 mg/dL), Acetylsalicylic Acid (65.16 mg/dL), Ascorbic Acid (5.98 mg/dL), Ibuprofen (50.1 mg/dL), Acetaminophen (20 mg/dL) Urine: Hemoglobin (501 mg/dL), Total Bilirubin (27.20 mg/dL), Ascorbic Acid (5.98 mg/dL), pH (No impact), Specific Gravity (1.000-1.030) |
| Matrix Comparison with Predicate | Good correlation (e.g., r close to 1, slope close to 1, intercept close to 0) (CLSI guideline EP09-A3) | Plasma Glucose (mg/dL): N=56, Intercept=-0.070, Slope=0.991, r=0.999 Plasma Glucose (mmol/L): N=56, Intercept=0.013, Slope=0.988, r=0.999 |
| Method Comparison with Predicate | Good correlation (e.g., r close to 1, slope close to 1, intercept close to 0) (CLSI guideline EP09-A3) | Serum Glucose (mg/dL): N=141, Intercept=-2.453, Slope=1.005, r=0.996 Urine Glucose (mg/dL): N=100, Intercept=0.975, Slope=1.007, r=0.999 |
| Reagent Stability | Stable up to expiry date | Closed: Stable up to expiry date at 2-8°C Open: Stable for 6 weeks on board in refrigerated compartment |
| Reference Range | Verification supports ranges cited in literature (CLSI guideline EP28-A3c) | Serum: Literature Range: 70-115 mg/dL (3.89-6.39 mmol/L) Urine: Literature Range: < 15 mg/dL (< 0.84 mmol/L) |
ISE Module (Sodium, Potassium, Chloride Electrodes):
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Measuring Range | Validation by linearity studies | Serum: NA: 100-200 mmol/L, K: 1.5-10 mmol/L, CL: 52-200 mmol/L Urine: NA: 10-400 mmol/L, K: 3-300 mmol/L, CL: 15-400 mmol/L |
| Repeatability (within-run precision) | Acceptable CV% (Tested 20 times by 3 reagent lots) | Serum Controls/Samples: NA 0.2-0.3% CV, K 0.1-0.4% CV, CL 0.2-0.4% CV Urine Controls/Samples: NA 0.3-1.2% CV, K 0.3-0.5% CV, CL 0.2-0.4% CV |
| Reproducibility (total precision) | Acceptable CV% (CLSI guideline EP05-A3, Tested in duplicate for 20 days, 2 series/day) | Serum Controls/Samples: NA 0.3-0.4% CV, K 0.5-1.6% CV, CL 0.3-0.4% CV Urine Controls/Samples: NA 0.4-1.5% CV, K 0.6-1.6% CV, CL 0.4-3.1% CV |
| Interferences | Calculated bias within 10% (CLSI EP07-A2) | Serum: Hemoglobin (0.5 g/dL), Triglycerides (52.1 mmol/L), Total Bilirubin (396 µmol/L), Total protein (121.13 g/L), Urea (71.9 mmol/L), Salicylic acid (0.53 mmol/L), Imipramine (2.50 µmol/L), Procainamide (102 µmol/L), Chlorpromazine (6.30 µmol/L), Erythromycin (81.6 µmol/L), Ampicillin (150 µmol/L) Urine: Hemoglobin (1.25 g/dL), Total Bilirubin (256 µmol/L), Protein (3.31 g/L), Urea (988.3 mmol/L), Ascorbic acid (3.40 mmol/L) |
| Matrix Comparison with Predicate | Good correlation (e.g., r close to 1, slope close to 1, intercept close to 0) (CLSI guideline EP09-A3) | Plasma (vs. Olympus AU400): NA: N=171, Intercept=0.200, Slope=1.000, r=0.997 K: N=173, Intercept=0.010, Slope=1.000, r=0.999 CL: N=173, Intercept=-1.568, Slope=1.019, r=0.998 |
| Method Comparison with Reference | Good correlation (e.g., r close to 1, slope close to 1, intercept close to 0) (CLSI guideline EP09-A3) | Serum (vs. Commercial ISE module): NA: N=165, Intercept=1.371, Slope=0.987, r=0.995 K: N=170, Intercept=0.023, Slope=0.994, r=0.999 CL: N=172, Intercept=0.818, Slope=0.992, r=0.998 Urine (vs. Commercial ISE module): NA: N=194, Intercept=-1.256, Slope=1.001, r=1.000 K: N=198, Intercept=-0.128, Slope=0.983, r=0.999 CL: N=194, Intercept=0.525, Slope=0.991, r=1.000 |
| Electrodes Stability | Stable up to expiry date / for specified period | Closed: Stable up to expiry date at 0-40°C (JEOL internal protocol) Open: Stable for 3 months from opened (JEOL internal protocol) |
| Reference Range | Verification supports ranges cited in literature (CLSI EP28-A3c) | Serum/Plasma: NA: 136-145 mmol/L, K: 3.5-5.1 mmol/L, CL: 98-107 mmol/L Urine (24h): NA: 40-220 mmol/day, K: 25-125 mmol/day, CL: 110-250 mmol/day |
2. Sample sizes used for the test set and the data provenance
-
Yumizen C1200 Glucose HK:
- Matrix Comparison: 56 plasma samples.
- Method Comparison: 141 serum samples, 100 urine samples.
- Repeatability/Reproducibility: 2 level controls and 5 samples (low, middle, high concentrations), tested 20 times for repeatability. 2 level controls and 5 patient samples, tested in duplicate for 20 days (2 series per day) for reproducibility. Specific number of patient samples for these is not explicitly stated beyond "5 samples".
- Reference Range: 50 normal samples (25 women + 25 men) in serum.
- Data Provenance: Not explicitly stated, but typically clinical laboratory studies involve diverse populations to ensure generalizability. Given the HORIBA ABX SAS (France) and HORIBA, Ltd. (Japan) affiliations, it's possible the data originates from those regions. It is prospective data collection for the studies.
-
ISE Module (Sodium, Potassium, Chloride Electrodes):
- Matrix Comparison (vs. Olympus AU400 Plasma): NA: 171 plasma samples, K: 173 plasma samples, CL: 173 plasma samples.
- Method Comparison (vs. Commercial ISE module): NA in serum: 165, K in serum: 170, CL in serum: 172. NA in urine: 194, K in urine: 198, CL in urine: 194.
- Repeatability/Reproducibility: 2 level controls, 3 samples (low, middle, high concentration), and spiked samples. Tested 20 times by 3 reagent Lots for repeatability. Tested in duplicate for 20 days (2 series per day) for reproducibility. Specific number of patient samples for these is not explicitly stated beyond "3 samples".
- Reference Range: 80 normal samples (23 women + 57 men) in serum and plasma.
- Data Provenance: Not explicitly stated, likely similar to Glucose HK, prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are in vitro diagnostic devices for quantitative measurements, not subject to expert interpretation of images or other subjective data. The "ground truth" or reference values are established by the predicate devices or scientifically validated methods as outlined in CLSI guidelines.
4. Adjudication method for the test set
Not applicable, as this is a quantitative analytical device. The "ground truth" is determined by reference methods (predicate devices, commercial reagents) and established analytical procedures (e.g., CLSI guidelines).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an IVD device for automated chemical measurement, not an AI-assisted diagnostic imaging or human-in-the-loop system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies reported are inherently standalone performance evaluations of the analytical device (Yumizen C1200) and its associated reagents/electrodes. The performance data presented (measuring range, accuracy, precision, interferences, method comparisons) reflects the device's ability to measure analytes quantitatively without human interpretive input beyond sample loading and report generation.
7. The type of ground truth used
The "ground truth" for the performance studies is established by:
- Predicate devices: For the method and matrix comparison studies, the results from the legally marketed predicate devices (Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer and HORIBA ABX PENTRA Glucose HK CP on Pentra C400 for Glucose HK; Olympus AU400 Clinical Chemistry Analyzer and a commercial ISE module for the ISE electrodes) serve as the reference for comparison.
- CLSI guidelines: Adherence to Clinical and Laboratory Standards Institute (CLSI) guidelines (e.g., EP17-A2, EP06-A, EP05-A3, EP07-A2, EP09-A3, EP28-A3c) indicates that the methods for determining limits, precision, linearity, interferences, and method comparisons follow accepted industry standards.
- Literature-cited reference ranges: For establishing the "normal" range for serum/plasma/urine concentrations, existing scientific literature is used as the reference.
8. The sample size for the training set
Not applicable. This is an analytical device for quantitative chemical measurements, not an algorithm that requires a "training set" in the context of machine learning or AI. The device's performance characteristics are determined by its physical design, chemical reactions, and operational parameters, which are validated through the performance studies described.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the machine learning/AI sense for this type of IVD device.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.
February 12, 2019
Horiba. Ltd Naoyuki Nomura Medical Segment Strategy Office Assistant Section Leader 2 Miyanohigashi, Kisshoin, Minami-ku Kyoto, 601-8510 Japan
Re: K183375
| Trade/Device Name: | Yumizen C1200 Glucose HKSodium ElectrodePotassium ElectrodeChloride ElectrodeYumizen C1200 |
|---|---|
| Regulation Number: | 21 CFR 862.1345 |
| Regulation Name: | Glucose test system |
| Regulatory Class: | Class II |
| Product Code: | CFR, JGS, CEM, CGZ, JJE |
| Dated: | November 30, 2018 |
| Received: | December 6, 2018 |
Dear Naoyuki Nomura:
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.
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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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (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, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Ke
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) K183375
Device Name
Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
Indications for Use (Describe)
The Yumizen C1200 Glucose HK reagent is intended for the quantitative in vitro diagnostic determination of gluose in human serum, plasma, and urine using a glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
The sodium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The sodium electrode is used to quantify the concentrations of sodium ions in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
The potassium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The potassium electrode is used to quantify the concentrations of potassium ions in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
The chloride electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is used to quantify the concentrations of chloride ions in serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Yumizen C1200 is an automatic chemistry analyzer that measures in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use.
| 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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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: K183375.
Date of Summary:
02/08/2019
Product Name
Yumizen C1200
Sponsor
HORIBA, Ltd. 2 Miyanohigashi, Kisshoin, Minami-ku, Kyoto 601-8510, Japan
Correspondent
Naoyuki Nomura 2 Miyanohigashi, Kisshoin, Minami-ku, Kyoto 601-8510, Japan +81-80-4358-0440 naoyuki.nomura@horiba.com
Device Trade or Proprietary Name
| 1. Clinical Chemistry Analyzer |
|---|
| Trade/Proprietary Name: Yumizen C1200 |
| Common or Usual Name: Clinical Chemistry Analyzer |
| Device Class: Class I |
| Regulation: §862.2160 |
| Classification Name: Discrete photometric chemistry analyzer for clinical use |
| Product Code: JJE: Analyzer, Chemistry (Photometric, Discrete), For |
| Clinical Use |
| Review Panel Clinical Chemistry |
| 2. Glucose |
| Trade/Proprietary Name: Yumizen C1200 Glucose HK |
| Common or Usual Name: Glucose HK |
| Device Class: Class II |
| Regulation: §862.1345 |
| Classification Name: Glucose test system |
| Product Code: CFR: Hexokinase, Glucose |
| Review Panel Clinical Chemistry |
| 3. ISE module |
| Trade/Proprietary Name: Sodium Electrode |
| Common or Usual Name: Sodium Electrode |
| Device Class: Class II |
| Regulation: §862.1665 |
| Classification Name: Sodium test system |
| Product Code: JGS: Electrode, Ion Specific, Sodium |
| Review Panel Clinical Chemistry |
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| Trade/Proprietary Name: | Potassium Electrode |
|---|---|
| Common or Usual Name: | Potassium Electrode |
| Device Class: | Class II |
| Regulation: | §862.1600 |
| Classification Name: | Potassium test system |
| Product Code: | CEM: Electrode, Ion Specific, Potassium |
| Review Panel | Clinical Chemistry |
| Trade/Proprietary Name: | Chloride Electrode |
| Common or Usual Name: | Chloride Electrode |
| Device Class: | Class II |
| Regulation: | §862.1170 |
| Classification Name: | Chloride test system |
| Product Code: | CGZ: Electrode, Ion-Specific, Chloride |
| Review Panel | Clinical Chemistry |
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Substantial Equivalency
| Investigational Device | Primary Predicate Device name | Primary predicate devicemanufacturer | k number |
|---|---|---|---|
| Yumizen C1200 | DxC 700 AU Clinical Chemistry Analyzer | Beckman Coulter, Inc. | K161837 |
| Yumizen C1200 Glucose HK | ABX PENTRA Glucose HK CP on Pentra C400CLINICAL CHEMISTRY ANALYZER | HORIBA ABX SAS | K081276 |
| Sodium Electrode | |||
| Potassium Electrode | ISE reagents on DxC 700 AU Clinical Chemistry Analyzer | Beckman Coulter, Inc. | K161837 |
| Chloride Electrode |
1. Device Comparison between Yumizen C1200 and DxC 700 AU Clinical Chemistry Analyzer table
| Item | Primary Predicate Device nameDxC 700 AU Clinical Chemistry AnalyzerK161837 | Investigational DeviceYumizen C1200 |
|---|---|---|
| Manufactured by | Beckman Coulter, Inc. | JEOL Ltd. |
| Instrument type | Stand type | Same |
| Work station | Separate | Same |
| Throughput | Without ISE: 800 tests/hWith ISE :1200 tests/h | Same |
| Sample treatment | ||
| Sample type | Serum, Plasma, Urine, Cerebrospinal fluid (CSF) | Serum, Plasma, Urine |
| Sample input | Sample rack, STAT Table, Direct-line SampleAspiration (For Automation Connections) | Sample tray, STAT Table |
| Sample volume | 1.0 to 25.0 µL | Same |
| Parameters on board | 60 photometric tests + 3 ISEs | 45 photometric tests + 3 ISEs |
| Sample capacity | 150 (15 racks x 10 samples) | 84 (2 Sample tray x 42 samples) |
| Bar-code reader | Integrated | Same |
| Dilution of patient sample | Yes | Same |
| Reagent | ||
| Type of reagent | Liquid | Same |
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| Item | Primary Predicate Device nameDxC 700 AU Clinical Chemistry AnalyzerK161837 | Investigational DeviceYumizen C1200 |
|---|---|---|
| Refrigerated | Reagent 1: 60 bottles capacityReagent 2: 48 bottles capacity | Reagent 1: 45 bottles capacityReagent 2: 45 bottles capacity |
| Sample Analysis | ||
| Total reaction volume | Min: 120 µL, Max: 350 µL | Min: 80 µL, Max: 430 µL |
| Cuvette material | Glass | Plastic |
| Washable cuvettes | Same | |
| Number of cuvette | 165 | 231 |
| Halogen lamp | Same | |
| 340 to 800 nm | 340 to 884 nm | |
| Wave length | 13 wavelengths: 340, 380, 410, 450, 480, 520,540, | 14 wavelengths: 340, 410, 451, 478, 505, |
| 570, 600, 660, 700, 750 and 800 nm (maximum of 2 | 545, 571, 596, 658, 694, 751, 805, 845 and | |
| wavelengths) | 884 nm (maximum of 2 wavelengths) | |
| Endpoint assay | Endpoint assay (EPA) | |
| Reaction rate assay | Reaction rate assay (RRA) | |
| Type of measurement | Fixed point assay | 2-point assay (2PA) |
| Constant rate assay (CRA) | ||
| Immunoassay (IMA) | ||
| Electrode method (ISE) | Electrode method (ISE) | |
| Physical characteristics | ||
| Dimensions(W x D x H) | 1250 × 890 mm × 1300 mm | 1220 × 850 × 1108 mm |
| Weight | 465 kg | 450 kg |
| Item | Primary Predicate Device NameABX Pentra Glucose HK CPK081276 | Investigational DeviceYumizen C1200 Glucose HK |
| Manufactured by | HORIBA ABX SAS | Same |
| Instrument | Pentra C400 CLINICAL CHEMISTRY ANALYZER | Yumizen C1200 |
| Method | Enzymatic method using hexokinase coupled withglucose-6-phosphate dehydrogenase | Same |
| Sample type | Serum, Plasma, Urine | Same |
| Reagent format | Liquid | Same |
| Measuring Range | Serum: 0.11 - 50.00 mmol/L1.98 – 900.00 mg/dL | Serum: 0.10 – 35.00 mmol/L1.8 - 630.0 mg/dL |
| Measuring Range | Urine: 0.22 - 50.00 mmol/L3.96- 900.0 mg/dL | Urine: 0.47 - 35.0 mmol/L8.5-630.0 mg/dL |
| Measuring Range | Automatic post-dilution:Up to 150.00 mmol/L2700 mg/dL | Automatic post-dilution:Up to 140.00 mmol/L2520 mg/dL |
| Packaging | Reagent 1: 56 mLReagent 2: 14 mL | Reagent 1: 6 × 39 mLReagent 2: 6 × 13 mLReagent 1: 4 × 57 mLReagent 2: 3 × 26 mL |
| Calibrators | ABX PENTRA Multical | Yumizen C1200 Multical |
| Controls | ABX PENTRA N Control | Yumizen C1200 N Multi Control |
| Controls | ABX PENTRA P Control | Yumizen C1200 P Multi Control |
| Controls | ABX PENTRA Urine Control L/H | Yumizen C1200 Urine Level 1 Control |
| Controls | ABX PENTRA Urine Control L/H | Yumizen C1200 Urine Level 2 Control |
| Reagent stability | Open: Stable for 55 days on board | Open: Stable for 6 weeks on board |
| Reagent stability | Closed: Stable up to the expiry date on the label if storedat 2-8°C. | Same |
| Item | Primary Predicate Device nameISE reagents on DxC 700 AU Clinical ChemistryAnalyzerK161837 | Investigational DeviceYumizen C1200 |
| ISE parameters | NA, K, CL | Same |
| Potentiometry | Indirect | Same |
| Sample volume | 20 µL for 3 parameters | 22 µL for 3 parameters |
| Sodium Electrode | Crown ether membrane | Same |
| Potassium Electrode | Crown ether membrane | Same |
| Chloride Electrode | Super-layer solid molecule orientation membrane | Same |
| Reference Electrode | Sealed silver/silver chloride electrode | Same |
| Reagent | ISE Buffer SolutionISE Mid Standard SolutionISE Reference SolutionISE Internal Reference SolutionNa+/K+ Selectivity Check Solution | ISE Buffer (IS)Internal Standard |
| Calibrator | Low Serum StandardHigh Serum StandardLow/High Urine Standard | ISE Serum Standard Set (NA)ISE Urine Standard Set |
| Measurement | Quantitative | Same |
| Sample Type | Serum, Plasma, Urine | Same |
| Measuring range | Serum | |
| NA 50 – 200 mmol/LK 1.0 – 10.0 mmol/LCL 50 – 200 mmol/L | NA 100 – 200 mmol/LK 1.5 – 10 mmol/LCL 52 – 200 mmol/L | |
| Urine | ||
| NA 10 – 400 mmol/LK 2.0 – 200.0 mmol/LCL 15 – 400 mmol/L | NA 10 – 400 mmol/LK 3 – 300 mmol/LCL 15 – 400 mmol/L |
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2. Comparison between Yumizen C1200 Glucose HK and the ABX PENTRA Glucose HK CP table
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Intended Use
Yumizen C1200 Glucose HK 1.
The Yumizen C1200 Glucose HK reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma, and urine using a glucose hexokinase method by colorimetry. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypodycemia, idiopathic hypodlycemia, and pancreatic islet cell carcinoma,
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- ISE module
This ISE unit is designed for making quantitative measurements of Na (sodium), K (potassium), and Cl (chloride) in serum, plasma, and urine samples. This unit is intended for professional use in a laboratory environment only.
- ISE module
2.1 Sodium Electrode
The sodium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The sodium electrode is used to quantify the concentrations of sodium ions in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst). adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
2.2 Potassium Electrode
The potassium electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The potassium electrode is used to quantify the concentrations of potassium ions in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels.
2.3 Chloride Electrode
The chloride electrode is an ion selective electrode that is intended for use on the ion selective electrode (ISE) unit of the Yumizen C1200 analyzer. The chloride electrode is used to quantify the concentrations of chloride ions in serum, plasma, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
3. Yumizen C1200
The Yumizen C1200 is an automatic chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. Applications include colorimetric and ion selective electrode. This analyzer is intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use.
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Methodology
- The chemistry principles of Operations 1. The operation principle of Yumizen C1200 system is as follows
Image /page/11/Figure/2 description: The image shows a diagram of a clinical chemistry analyzer. The diagram labels the different parts of the analyzer, including the reaction carousel, reaction bath, spectrophotometer, sample probe unit, sample barcode reader, sample tray, reagent probe units, reagent trays, reagent barcode readers, mixers, sampling pump, reagent pumps, A/D converter, CPU controller, and data processing CPU. The analyzer is used to perform chemical tests on samples.
The reagent probe (RPP) dispenses reagent 1 (R1) from reagent tray 1 (RTT1) to a clean reaction cuvette on the reaction carousel (RRV). The sample probe (SPP) dispenses the sample in the quantity required for the test from the sample tray (STT) into the RRV now containing R1. Sample dilution is possible if necessary. The diluent is placed in the RTT and dispensed into the reaction cuvette. Next, the sample is dispensed into the same cuvette by the SPP and mixed with the mixing rod. Now the diluted sample is in the reaction cuvette. The SPP dispenses the diluted sample in the reaction cuvette in which R1 required for the test has already been dispensed. The dispensed sample and R1 are mixed in the reaction cuvette. Next, reagent 2/2 early (e) is dispensed from the RTT as required. The contents are then mixed for the length of time required by the test. Photometric measurement data is collected by the spectrophotometer every 13.5 seconds to calculate concentration at each measurement point, which are posted to the workstation. The reaction cuvettes are washed with detergent and tepid water and blank measurement is performed for each wavelength.
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- The measuring assay of glucose
Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phospage (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD*) to nicotinamide adenine dinucleotide(NADH), reduced. The change in absorbance at 340/410 nm is proportional to the amount of glucose present in the sample.
- The measuring assay of glucose
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| HK | |
|---|---|
| D-glucose + ATP | -> Glucose-6-phosphate + ADP |
| G-6-PDH | |
|---|---|
| Glucose-6-phosphate + NAD+ | -> D-gluconate-6-phosphate + NADH + H+ |
- The measuring assay of Electrodes 3.
The ISE module employs membrane electrodes for sodium, potassium and chloride that are specific for each ion of interest in the sample. An electrical potential is developed according to the Nernst Equation for a specific ion. When compared to the Internal Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.
Each of the selected electrodes is composed of the following membrane
- NA: Crown ether membrane >
-
K: Crown ether membrane
- V CL: Super-layer solid molecule orientation membrane
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Performance Data
- Yumizen C1200 Glucose HK
1.1 Measuring Range
The limit of detection and quantitation was determined according to the CLSI guideline EP17-A2.
The reagent linearity was determined according to CLSI guideline EP06-A.
The limit of quantitation and the linearity studies showed that claimed measuring ranges are appropriate.
| Limit of quantitation | Measuring range | |
|---|---|---|
| Serum / plasma | 1.8 mg/dL0.10 mmol/L | 1.8 to 630.0 mg/dL0.10 to 35.00 mmol/L |
| Urine | 3.5 mg/dL0.19 mmol/L | 8.5 to 630.0 mg/dL0.47 to 35.00 mmol/L |
| Post-dilution | NA | In serum / plasma /urineUp to 2520.0 mg/dLUp to 140.00 mmol/L |
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1.2 Accuracy and Precision
1.2.1 Repeatability (within-run precision)
2 level controls and 5 samples of low, middle, and high concentrations were tested 20 times.
| Serum | Urine | |||||||
|---|---|---|---|---|---|---|---|---|
| Mean value | CV % | Mean value | CV % | |||||
| mg/dL | mmol/L | mg/dL | mmol/L | mg/dL | mmol/L | mg/dL | mmol/L | |
| Control N | 91.91 | 5.106 | 1.1 | 1.1 | 23.85 | 1.325 | 0.5 | 0.6 |
| Control P | 275.02 | 15.278 | 0.7 | 0.7 | 294.27 | 16.348 | 0.6 | 0.6 |
| Sample 1 | 9.92 | 0.551 | 1.1 | 1.0 | 11.13 | 0.617 | 0.9 | 0.8 |
| Sample 2 | 30.80 | 1.711 | 0.9 | 0.9 | 17.07 | 0.949 | 1.0 | 0.9 |
| Sample 3 | 96.52 | 5.362 | 0.8 | 0.8 | 178.71 | 9.928 | 0.5 | 0.5 |
| Sample 4 | 272.07 | 15.115 | 0.8 | 0.8 | 353.08 | 19.616 | 0.8 | 0.8 |
| Sample 5 | 556.09 | 30.894 | 0.5 | 0.5 | 570.28 | 31.682 | 0.6 | 0.6 |
1.2.2 Reproducibility (total precision)
2 level controls and 5 patient samples of low, middle and high level concentrations were tested in duplicate for 20 days (2 series per day) according to the CLSI guideline EP05-A3.
| Serum | Urine | |||||||
|---|---|---|---|---|---|---|---|---|
| Mean value | CV % | Mean value | CV % | |||||
| mg/dL | mmol/L | mg/dL | mmol/L | mg/dL | mmol/L | mg/dL | mmol/L | |
| Control N | 92.70 | 5.150 | 1.5 | 1.5 | 25.04 | 1.391 | 4.0 | 4.0 |
| Control P | 255.24 | 14.180 | 1.4 | 1.4 | 279.65 | 15.536 | 3.0 | 3.1 |
| Sample 1 | 12.65 | 0.703 | 2.3 | 2.2 | 11.87 | 0.660 | 3.6 | 3.6 |
| Sample 2 | 30.63 | 1.702 | 1.8 | 1.8 | 16.64 | 0.924 | 3.4 | 3.4 |
| Sample 3 | 103.56 | 5.753 | 1.7 | 1.7 | 174.80 | 9.711 | 3.2 | 3.2 |
| Sample 4 | 259.29 | 14.405 | 1.6 | 1.6 | 324.70 | 18.039 | 3.3 | 3.3 |
| Sample 5 | 571.87 | 31.770 | 1.6 | 1.6 | 537.47 | 29.859 | 4.3 | 4.3 |
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1.3 Interferences
The Interferences were determined according to the CLSI guideline EP07-A2.
The calculated bias was within the 10% acceptance citteria on serum and urine samples for up to the following concentrations.
| Serum | Urine | ||
|---|---|---|---|
| Hemoglobin | 501 mg/dL (290 µmol/L) | Hemoglobin | 501 mg/dL (290 µmol/L) |
| Triglycerides | 569 mg/dL (6.50 mmol/L) | Total Bilirubin | 27.20 mg/dL (465 µmol/L) |
| Total Bilirubin | 35.53 mg/dL (607 µmol/L) | Ascorbic Acid | 5.98 mg/dL (340 µmol/L) |
| Direct Bilirubin | 21.09 mg/dL (360 µmol/L) | Modification of the pH of the samples | No impact on glucose assay measurement |
| Acetylsalicylic Acid | 65.16 mg/dL (3.62 mmol/L) | Specific gravity | 1.000 - 1.030 |
| Ascorbic Acid | 5.98 mg/dL (340 µmol/L) | ||
| Ibuprofen | 50.1 mg/dL (2.43 mmol/L) | ||
| Acetaminophen | 20 mg/dL (1324 µmol/L) |
1.4 Matrix comparison on predicate device
This protocol was according to the CLSI guideline EP09-A3. 56 plasma samples were evaluated on Yumizen C1200 using Yumizen C1200 Glucose HK reagent and with the Pentra C400 Clinical Chemistry Analyzer with ABX PENTRA Glucose HK reagent (Predicate device). The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Intercept | Slope | Correlation - r |
|---|---|---|---|---|
| Glucose in plasma (mg/dL) | 56 | -0.070 | 0.991 | 0.999 |
| Glucose in plasma (mmol/L) | 56 | 0.013 | 0.988 | 0.999 |
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1.5 Method comparison with a predicate device
Yumizen C1200 was compared with Pentra C400 Clinical Chemistry Analyzer. 140 (in urine) patient samples were correlated with a commercial reagent taken as reference according to the CLSI quideline EP09-A3. The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Intercept | Slope | Correlation - r |
|---|---|---|---|---|
| Glucose in serum (mg/dL) | 141 | -2.453 | 1.005 | 0.996 |
| Glucose in urine (mg/dL) | 100 | 0.975 | 1.007 | 0.999 |
1.6 Reagent Stability
1.6.1 Closed stability
The closed stability was determined according to the CLSI guideline EP25-A. Stable up to the expiry date on the label if stored at 2 - 8 degree C.
1.6.2 Open stability
Stable up to the expiry date on the label if stored at the refrigerated compartment is stable for 6 weeks.
1.7 Reference Range
The Reference Range was determined according to the CLSI guideline EP28-A3c.
50 normal samples (25 women + 25 men) in serum were assayed with the method in evaluation. Each sample was assayed in duplicates. The mean of the duplicate results for each subject was compared against reference ranges cited in literature. The verification studied support in the following reference ranges which were established through literature.
Serum: 70 to 115 mg/dL (3.89 to 6.39 mmol/L)
Urine: < 15 mg/dL (< 0.84 mmol/L)
Reference
Thomas L. Clinical Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft: 1998. p. 131-7, 1368.
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2 ISE module on Yumizen C1200
2.1 Measuring Range
The measuring range of the Sodium, Potassium and Chloride Electrodes on Yumizen C1200 was validated by the linearity studies.
| Parameters | Measuring range |
|---|---|
| NA in serum (mmol/L) | 100 to 200 |
| K in serum (mmol/L) | 1.5 to 10 |
| CL in serum (mmol/L) | 52 to 200 |
| NA in urine (mmol/L) | 10 to 400 |
| K in urine (mmol/L) | 3 to 300 |
| CL in urine (mmol/L) | 15 to 400 |
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2.2 Accuracy and Precision
2.2.1 Repeatability (within-run precision)
The Repeatability was determined by analyzing 2 level controls, 3 samples of low, middle and high level concentration and the spiked samples were tested 20 times by 3 reagent Lots.
| Control in serum | Control N | Control P | Control N2 | Control P2 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | ||
| NA | Mean value (mmol/L) | 133.80 | 134.68 | 134.55 | 134.55 | 135.37 | 135.84 | 122.13 | 123.10 | 123.25 | 154.39 | 155.18 | 154.66 |
| CV (%) | 0.2 | 0.2 | 0.3 | 0.2 | 0.2 | 0.3 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | 0.2 | |
| K | Mean value (mmol/L) | 4.296 | 4.336 | 4.333 | 6.643 | 6.689 | 6.700 | 3.825 | 3.865 | 3.866 | 6.536 | 6.567 | 6.553 |
| CV (%) | 0.1 | 0.2 | 0.3 | 0.2 | 0.3 | 0.3 | 0.3 | 0.3 | 0.4 | 0.2 | 0.3 | 0.3 | |
| CL | Mean value (mmol/L) | 114.04 | 115.47 | 114.24 | 112.75 | 114.50 | 113.45 | 91.21 | 91.70 | 91.64 | 112.01 | 112.17 | 111.72 |
| CV (%) | 0.2 | 0.3 | 0.4 | 0.3 | 0.2 | 0.3 | 0.2 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | |
| Patient sample in serum | Low sample | Middle sample | High sample | Spiked sample | |||||||||
| Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | ||
| NA | Mean value (mmol/L) | 125.85 | 126.81 | 126.74 | 138.64 | 139.61 | 139.18 | 148.72 | 149.51 | 148.84 | 165.20 | 165.83 | 164.90 |
| CV (%) | 0.2 | 0.3 | 0.2 | 0.2 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.2 | 0.3 | 0.3 | |
| K | Mean value (mmol/L) | 2.773 | 2.779 | 2.784 | 4.041 | 4.067 | 4.065 | 5.847 | 5.896 | 5.899 | 6.688 | 6.742 | 6.733 |
| CV (%) | 0.2 | 0.3 | 0.3 | 0.3 | 0.3 | 0.2 | 0.2 | 0.2 | 0.3 | 0.3 | 0.3 | 0.3 | |
| CL | Mean value (mmol/L) | 90.61 | 90.89 | 90.46 | 101.81 | 102.29 | 101.71 | 112.79 | 113.09 | 112.46 | 130.18 | 130.35 | 129.65 |
| CV (%) | 0.2 | 0.3 | 0.2 | 0.2 | 0.4 | 0.3 | 0.4 | 0.4 | 0.3 | 0.3 | 0.3 | 0.3 |
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| Control in urine | Control N | Control P | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | |||||||||
| NA | Mean value(mmol/L) | 85.75 | 86.68 | 86.65 | 178.97 | 179.04 | 178.09 | |||||||
| CV (%) | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | 0.4 | ||||||||
| K | Mean value(mmol/L) | 31.102 | 31.160 | 31.104 | 83.437 | 83.453 | 83.115 | |||||||
| CV (%) | 0.5 | 0.5 | 0.4 | 0.4 | 0.4 | 0.4 | ||||||||
| CL | Mean value(mmol/L) | 62.04 | 62.48 | 66.09 | 163.60 | 162.67 | 171.54 | |||||||
| CV (%) | 0.4 | 0.3 | 0.4 | 0.2 | 0.2 | 0.3 | ||||||||
| Patient sample | ||||||||||||||
| Low sample | Middle sample | High sample | Spiked sample | |||||||||||
| in urine | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | Lot1 | Lot2 | Lot3 | ||
| Mean value(mmol/L) | 27.69 | 28.44 | 28.36 | 103.54 | 104.24 | 103.53 | 188.09 | 187.72 | 186.54 | 336.99 | 334.35 | 331.45 | ||
| NA | CV (%) | 1.0 | 0.8 | 1.2 | 0.2 | 0.2 | 0.3 | 0.2 | 0.3 | 0.3 | 0.3 | 0.3 | 0.3 | |
| K | Mean value(mmol/L) | 29.373 | 29.309 | 29.176 | 68.765 | 68.922 | 68.365 | 118.831 | 118.845 | 118.050 | 220.783 | 221.125 | 218.953 | |
| CV (%) | 0.5 | 0.3 | 0.3 | 0.4 | 0.3 | 0.5 | 0.4 | 0.3 | 0.4 | 0.5 | 0.5 | 0.5 | ||
| CL | Mean value(mmol/L) | 24.13 | 25.79 | 30.78 | 102.07 | 104.55 | 106.76 | 199.91 | 199.77 | 190.33 | 322.88 | 318.66 | 292.00 |
2.2.2 Reproducibility (total precision)
The Reproducibility was determined according to the CLSI guideline EP05-A3.
2 level controls, 3 samples of low, middle and high concentrations and the spiked samples were tested in duplicate for 20 days (2 series per day).
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| NA in serum | K in serum | CL in serum | ||||
|---|---|---|---|---|---|---|
| serum | Mean value(mmol/L) | CV (%) | Mean value(mmol/L) | CV (%) | Mean value(mmol/L) | CV (%) |
| Control N | 134.09 | 0.4 | 4.296 | 0.5 | 113.49 | 0.4 |
| Control P | 134.22 | 0.3 | 6.599 | 0.6 | 111.34 | 0.4 |
| Control N2 | 122.41 | 0.4 | 3.814 | 0.7 | 90.77 | 0.4 |
| Control P2 | 154.02 | 0.3 | 6.514 | 0.5 | 111.51 | 0.4 |
| Low sample | 126.47 | 0.3 | 2.800 | 1.6 | 90.25 | 0.3 |
| Middle sample | 139.09 | 0.3 | 4.058 | 0.6 | 101.59 | 0.3 |
| High sample | 148.82 | 0.3 | 5.861 | 0.6 | 112.36 | 0.3 |
| Spiked sample | 164.53 | 0.4 | 6.706 | 0.8 | 129.46 | 0.4 |
| NA in urine | K in urine | CL in urine | ||||
| urine | Mean value(mmol/L) | CV (%) | Mean value(mmol/L) | CV (%) | Mean value(mmol/L) | CV (%) |
| Control N | 85.31 | 0.7 | 31.131 | 0.7 | 60.40 | 1.8 |
| Control P | 179.90 | 0.4 | 84.269 | 0.6 | 162.60 | 1.2 |
| Low sample | 27.93 | 1.5 | 29.388 | 1.6 | 24.29 | 3.1 |
| Middle sample | 103.29 | 0.5 | 68.638 | 0.7 | 100.79 | 0.7 |
| High sample | 187.18 | 0.4 | 117.706 | 1.1 | 199.13 | 0.4 |
| Spiked sample | 335.21 | 0.7 | 222.108 | 1.3 | 323.05 | 0.6 |
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2.3 Interferences
This protocol was determined according to the CLSI EP07-A2.
The calculated bias was within the 10% acceptance criteria on Sodium, Potassium and urine samples for up to the following concentrations.
| NA, K, CL in serum | NA, K, CL in urine | ||
|---|---|---|---|
| Hemoglobin | 0.5 g/dL | Hemoglobin | 1.25 g/dL |
| Triglycerides | 52.1 mmol/L | Total Bilirubin | 256 µmol/L |
| Total Bilirubin | 396 µmol/L | Protein | 3.31 g/L |
| Total protein | 121.13 g/L | Urea | 988.3 mmol/L |
| Urea | 71.9 mmol/L | Ascorbic acid | 3.40 mmol/L |
| Salicylic acid | 0.53 mmol/L | ||
| Imipramine | 2.50 µmol/L | ||
| Procainamide | 102 µmol/L | ||
| Chlorpromazine | 6.30 µmol/L | ||
| Erythromycin | 81.6 µmol/L | ||
| Ampicillin | 150 µmol/L |
- 2.4 Matrix comparison on predicate device
This protocol was according to the CLSI guideline EP09-A3.
Plasma samples were evaluated on Yumizen C1200 and Olympus AU400 Clinical Chemistry Analyzer. The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Min (mmol/L) | Max (mmol/L) | Intercept | Slope | Correlation - r |
|---|---|---|---|---|---|---|
| NA | 171 | 102.9 | 188.9 | 0.200 | 1.000 | 0.997 |
| K | 173 | 1.76 | 9.53 | 0.010 | 1.000 | 0.999 |
| CL | 173 | 53.1 | 178.4 | -1.568 | 1.019 | 0.998 |
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2.5 Method comparison with a reference device
Yumizen C1200 was compared with Olympus AU400 Clinical Chemistry Analyzer.
The patient samples were correlated with a commercial ISE module taken as reference according to the CLSI guideline EP09-A3.
The equation for the regression line using Passing Bablok was obtained.
| Passing Bablok | N | Intercept | Slope | Correlation - r |
|---|---|---|---|---|
| NA in serum | 165 | 1.371 | 0.987 | 0.995 |
| K in serum | 170 | 0.023 | 0.994 | 0.999 |
| CL in serum | 172 | 0.818 | 0.992 | 0.998 |
| NA in urine | 194 | -1.256 | 1.001 | 1.000 |
| K in urine | 198 | -0.128 | 0.983 | 0.999 |
| CL in urine | 194 | 0.525 | 0.991 | 1.000 |
2.6 Electrodes Stability
The protocol of this study was followed by JEOL internal protocol.
The evaluation was performed using the same parameter checked in manufacturing of the electrodes.
2.6.1 Closed stability
Stable up to the expiry date on the label if stored at 0-40 degree C.
- 2.6.2 Open stability
Stable for 3 months from opened.
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2.7 Reference Range
The Reference Range was determined according to the CLSI EP28-A3c.
80 normal samples (23 women + 57 men) in serum and plasma were assayed with the method in evaluation. Each sample was assayed in duplicates. The mean of the duplicate results for each subject was compared against reference ranges cited from literature. The verification studies supported in the following reference ranges which were established through literature. NA in serum and plasma: 136 to 145 mmol/L1
K in serum and plasma: 3.5 to 5.1 mmol/L1
(The reference range of K in plasma is about 0.5 mmol/L lower than in serum)2
CL in serum and plasma: 98 to 107 mmol/L1
The expected values based on 24 hours urine out-put were cited from the literature.
NA in urine: 40 to 220 mmol/day1
K in urine: 25 to 125 mmol/day1
CL in urine: 110 to 250 mmol/day1
Reference:
-
Tietz NW, Clinical Guide for Laboratory Tests 3rd edition. WB Saunders Company, Philadelphia, PA, pp. 610-611 (1995)
-
Walker HK,et al. Clinical Methods: The History, Physical, and Laboratory Examinations, 3rd edition, Boston: Butterworths, pp 884-887(1990)
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Non clinical tests
The non clinical studies tests conclude that the safety and effectiveness of the devices are not compromised. Yumizen C1200 meets the following.
| ISO 14971: 2007 | Medical devices - Application of risk management to medical devices |
|---|---|
| IEC 61326-2-6:2012 | Electrical equipment for measurement, control and laboratory use — EMC requirements —Part 2-6: Particular requirements — In vitro diagnostic (IVD) medical equipment |
| IEC 61326-1: 2012 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part1: General requirements |
| IEC 61010-1: 2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use —Part 1 General requirements |
| IEC 61010-2-010: 2014 | Safety requirements for electrical equipment for measurement, control and laboratory use -Part 2-010: Particular requirements for laboratory equipment for the heating of materials |
| IEC 61010-2-101: 2015 | Safety requirements for electrical equipment for measurement, control, and laboratory use —Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment |
| IEC 62304: 2006 | Medical device software — software life-cycle processes |
| IEC 60825-1 2014 | Safety of laser products - Part 1: Equipment classification and requirements |
Conclusion
The data presented demonstrate that the Yumizen C1200 glucose, sodium, and chloride assays are substantially equivalent to the predicate devices.
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(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.