(68 days)
Not Found
No
The summary describes a standard automatic chemistry analyzer using photometric and ion selective electrode methods, with no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic (IVD) device used to quantify glucose, sodium, potassium, and chloride concentrations in human samples. Its purpose is to provide diagnostic information, not to directly treat or prevent a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "quantitative in vitro diagnostic determination" and that its measurements "are used in the diagnosis and treatment of" various medical conditions. The "Device Description" section also notes that "Tests performed using this analyzer are intended for in vitro diagnostic use."
No
The device is described as an "automatic chemistry analyzer" that includes hardware components like ion selective electrodes and uses photometric measurement. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states that the Yumizen C1200 Glucose HK reagent is intended for "quantitative in vitro diagnostic determination" and that the tests performed using the analyzer are intended for "in vitro diagnostic use."
- Purpose: The device is used to measure analytes (glucose, sodium, potassium, chloride) in human samples (serum, plasma, urine) to aid in the diagnosis and treatment of various diseases and conditions. This is the core function of an IVD.
- Sample Type: The device analyzes biological samples taken from the human body (in vitro).
- Clinical Context: The measurements obtained are used in a clinical context for diagnosis and treatment decisions.
- Regulatory Language: The use of terms like "in vitro diagnostic determination," "diagnosis and treatment," and the reference to CLSI guidelines (which are standard for IVD validation) all point to the device being an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CFR, JGS, CEM, CGZ, JJE
Device Description
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 an automatic clinical chemistry analyzer that performs chemical tests on samples. It consists of a 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 reagent probe dispenses reagent 1 (R1) into a clean reaction cuvette on the reaction carousel. The sample probe dispenses the sample into the cuvette, with optional dilution. Reagent 2/2 early (e) is then dispensed, followed by mixing. Photometric measurement data is collected by the spectrophotometer every 13.5 seconds to calculate concentration. The reaction cuvettes are washed and blank measurement is performed.
The Yumizen C1200 Glucose HK reagent performs quantitative in vitro diagnostic determination of glucose using a glucose hexokinase method by colorimetry. Glucose is phosphorylated by hexokinase (HK) in the presence of ATP and magnesium ions to produce glucose-6-phosphate (G-6-P) and ADP. Glucose-6-phosphate dehydrogenase (G-6-PDH) oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of NAD+ to NADH. The change in absorbance at 340/410 nm is proportional to the glucose amount.
The ISE module employs membrane electrodes for sodium, potassium, and chloride ions. An electrical potential is developed according to the Nernst Equation for a specific ion, which is translated into voltage and then into ion concentration. The sodium electrode and potassium electrode use a Crown ether membrane, while the chloride electrode uses a Super-layer solid molecule orientation membrane. The reference electrode is a sealed silver/silver chloride electrode.
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
Professional use in a laboratory environment only.
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)
1. Yumizen C1200 Glucose HK
- 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.
- Serum/plasma: 1.8 to 630.0 mg/dL (0.10 to 35.00 mmol/L)
- Urine: 8.5 to 630.0 mg/dL (0.47 to 35.00 mmol/L)
- Post-dilution: Up to 2520.0 mg/dL (Up to 140.00 mmol/L)
- Accuracy and Precision:
- Repeatability (within-run precision): 2 level controls and 5 samples (low, middle, high concentrations) were tested 20 times. CV% ranged from 0.5% to 1.1% for serum and 0.5% to 1.0% for urine samples.
- Reproducibility (total precision): 2 level controls and 5 patient samples (low, middle, high level concentrations) were tested in duplicate for 20 days (2 series per day) according to CLSI guideline EP05-A3. CV% ranged from 1.4% to 2.3% for serum and 3.0% to 4.3% for urine samples.
- Interferences: Determined according to CLSI guideline EP07-A2. Calculated bias was within 10% acceptance criteria for various interferents (Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen) in serum and urine samples.
- Matrix comparison on predicate device: According to 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). Passing Bablok regression: Intercept -0.070 (mg/dL), 0.013 (mmol/L), Slope 0.991 (mg/dL), 0.988 (mmol/L), Correlation (r) 0.999 for both.
- Method comparison with a predicate device: According to CLSI guideline EP09-A3. 140 (in urine) patient samples were correlated with a commercial reagent taken as reference. Passing Bablok regression:
- Glucose in serum (mg/dL): N=141, Intercept -2.453, Slope 1.005, r=0.996
- Glucose in urine (mg/dL): N=100, Intercept 0.975, Slope 1.007, r=0.999
- Reagent Stability:
- Closed stability: Determined according to CLSI guideline EP25-A. Stable up to the expiry date on the label if stored at 2-8°C.
- Open stability: Stable for 6 weeks in the refrigerated compartment.
- Reference Range: Determined according to CLSI guideline EP28-A3c. Based on 50 normal samples, verified against literature.
- Serum: 70 to 115 mg/dL (3.89 to 6.39 mmol/L)
- Urine:
§ 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.
0
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 HK
Sodium Electrode
Potassium Electrode
Chloride Electrode
Yumizen 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.
1
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
2
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 |
5
| 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 |
6
Substantial Equivalency
| Investigational Device | Primary Predicate Device name | Primary predicate device
manufacturer | 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 C400
CLINICAL 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 name
DxC 700 AU Clinical Chemistry Analyzer
K161837 | Investigational Device
Yumizen C1200 |
|----------------------------|----------------------------------------------------------------------------------------|-----------------------------------------|
| Manufactured by | Beckman Coulter, Inc. | JEOL Ltd. |
| Instrument type | Stand type | Same |
| Work station | Separate | Same |
| Throughput | Without ISE: 800 tests/h
With 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 Sample
Aspiration (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 |
7
| Item | Primary Predicate Device name
DxC 700 AU Clinical Chemistry Analyzer
K161837 | Investigational Device
Yumizen C1200 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Refrigerated | Reagent 1: 60 bottles capacity
Reagent 2: 48 bottles capacity | Reagent 1: 45 bottles capacity
Reagent 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 Name
ABX Pentra Glucose HK CP
K081276 | Investigational Device
Yumizen C1200 Glucose HK |
| Manufactured by | HORIBA ABX SAS | Same |
| Instrument | Pentra C400 CLINICAL CHEMISTRY ANALYZER | Yumizen C1200 |
| Method | Enzymatic method using hexokinase coupled with
glucose-6-phosphate dehydrogenase | Same |
| Sample type | Serum, Plasma, Urine | Same |
| Reagent format | Liquid | Same |
| Measuring Range | Serum: 0.11 - 50.00 mmol/L
1.98 – 900.00 mg/dL | Serum: 0.10 – 35.00 mmol/L
1.8 - 630.0 mg/dL |
| Measuring Range | Urine: 0.22 - 50.00 mmol/L
3.96- 900.0 mg/dL | Urine: 0.47 - 35.0 mmol/L
8.5-630.0 mg/dL |
| Measuring Range | Automatic post-dilution:
Up to 150.00 mmol/L
2700 mg/dL | Automatic post-dilution:
Up to 140.00 mmol/L
2520 mg/dL |
| Packaging | Reagent 1: 56 mL
Reagent 2: 14 mL | Reagent 1: 6 × 39 mL
Reagent 2: 6 × 13 mL
Reagent 1: 4 × 57 mL
Reagent 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 stored
at 2-8°C. | Same |
| Item | Primary Predicate Device name
ISE reagents on DxC 700 AU Clinical Chemistry
Analyzer
K161837 | Investigational Device
Yumizen 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 Solution
ISE Mid Standard Solution
ISE Reference Solution
ISE Internal Reference Solution
Na+/K+ Selectivity Check Solution | ISE Buffer (IS)
Internal Standard |
| Calibrator | Low Serum Standard
High Serum Standard
Low/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/L
K 1.0 – 10.0 mmol/L
CL 50 – 200 mmol/L | NA 100 – 200 mmol/L
K 1.5 – 10 mmol/L
CL 52 – 200 mmol/L |
| | Urine | |
| | NA 10 – 400 mmol/L
K 2.0 – 200.0 mmol/L
CL 15 – 400 mmol/L | NA 10 – 400 mmol/L
K 3 – 300 mmol/L
CL 15 – 400 mmol/L |
8
2. Comparison between Yumizen C1200 Glucose HK and the ABX PENTRA Glucose HK CP table
9
10
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,
-
- 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.
11
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.
-
- 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
12
| 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
13
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/dL | |
| 0.10 mmol/L | 1.8 to 630.0 mg/dL | |
| 0.10 to 35.00 mmol/L | ||
| Urine | 3.5 mg/dL | |
| 0.19 mmol/L | 8.5 to 630.0 mg/dL | |
| 0.47 to 35.00 mmol/L | ||
| Post-dilution | NA | In serum / plasma /urine |
| Up to 2520.0 mg/dL | ||
| Up to 140.00 mmol/L |
14
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 |
15
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 |
16
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: