Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode
Device Facts
| Record ID | K183375 |
|---|---|
| Device Name | Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode |
| Applicant | Horiba, Ltd. |
| Product Code | JJE · Clinical Chemistry |
| Decision Date | Feb 12, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2160 |
| Device Class | Class 1 |
| Attributes | Pediatric |
Indications for Use
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 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 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. 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 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.
Device Story
Yumizen C1200 is an automated clinical chemistry analyzer for professional laboratory use. It processes serum, plasma, and urine samples using photometric (colorimetric) and ion-selective electrode (ISE) modules. Input samples are loaded via trays; reagent probes dispense reagents into reaction cuvettes; mixing rods ensure homogeneity. Photometric measurements are taken via spectrophotometer (340-884 nm) to calculate analyte concentrations; ISE modules use membrane electrodes (crown ether for Na/K, super-layer solid molecule orientation for Cl) to measure electrical potential based on the Nernst equation. Data is processed by an internal CPU and output to a workstation. Results assist clinicians in diagnosing metabolic and electrolyte disorders. The system includes automated washing of cuvettes and calibration/QC protocols.
Clinical Evidence
Bench testing only. Performance validated per CLSI guidelines (EP17-A2, EP06-A, EP05-A3, EP07-A2, EP09-A3, EP28-A3c). Glucose HK assay demonstrated linearity (1.8-630 mg/dL serum), repeatability (CV 0.5-1.1%), and reproducibility (CV 1.4-4.3%). ISE module validated for Na, K, Cl across clinical ranges with high correlation (r > 0.99) against reference analyzers (Olympus AU400). Interference testing confirmed bias <10% for common substances.
Technological Characteristics
Automatic chemistry analyzer; photometric and ISE modules. Materials: plastic cuvettes. Sensing: spectrophotometry (340-884 nm) and ion-selective electrodes (crown ether and solid molecule orientation membranes). Connectivity: standalone laboratory instrument. Software: IEC 62304 compliant. Sterilization: N/A (laboratory equipment).
Indications for Use
Indicated for quantitative in vitro diagnostic determination of glucose, sodium, potassium, and chloride in human serum, plasma, and urine. Used for diagnosis and treatment of carbohydrate metabolism disorders (diabetes, hypoglycemia, carcinoma), electrolyte imbalances (aldosteronism, diabetes insipidus, hypertension, Addison's disease, dehydration), and metabolic disorders (cystic fibrosis, diabetic acidosis). Intended for professional laboratory use.
Regulatory Classification
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.
Predicate Devices
- DxC 700 AU Clinical Chemistry Analyzer (k161837)
- ABX PENTRA Glucose HK CP on Pentra C400 CLINICAL CHEMISTRY ANALYZER (k081276)
- ISE reagents on DxC 700 AU Clinical Chemistry Analyzer (k161837)
Related Devices
- K160370 — BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 9, 2016
- K220977 — ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer · Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. · Jul 20, 2023
- K140690 — BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2, 2014
Submission Summary (Full Text)
{0}
510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k183375
B. Purpose for Submission:
New device
C. Measurands:
Glucose, sodium, potassium, and chloride
D. Type of Test:
Glucose – quantitative, enzymatic (glucose hexokinase)
Sodium, potassium, and chloride – quantitative, ion selective electrode
E. Applicant:
Horiba, Ltd.
F. Proprietary and Established Names:
Yumizen C1200 Glucose HK
Sodium Electrode
Potassium Electrode
Chloride Electrode
Yumizen C1200
G. Regulatory Information:
| Regulation Section | Classification | Product Code | Panel |
| --- | --- | --- | --- |
| 862.1345 Glucose test system | Class 2 | CFR | Chemistry (75) |
| 862.1665 Sodium test system | | JGS | |
| 862.1600 Potassium test system | | CEM | |
| 862.1170 Chloride test system | | CGZ | |
| 862.2160 analyzer Discrete photometric chemistry analyzer for clinical use. | Class 1 | JJE | |
1
{1}
H. Intended Use:
1. Intended use(s):
Refer to Indications for Use
2. Indication(s) for use:
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 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 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.
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 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.
2
{2}
3. Special conditions for use statement(s):
For in vitro diagnostic use only.
4. Special instrument requirements:
Yumizen C1200
I. 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 intended for professional use in a laboratory environment only. Tests performed using this analyzer are intended for in vitro diagnostic use.
The Yumizen C1200 Glucose HK reagent consists of:
Reagent 1: TRIS Buffer, pH 7.8 100 mmol/L, Mg²⁺ 4 mmol/L, NAD⁺ 2.1 mmol/L and ATP 2.1 mmol/L.
Reagent 2: Hexokinase (HK) ≥ 7500 U/L, G-6-PDH ≥ 7500 U/L, and Mg²⁺ 4 mmol/L.
The ISE reagent consists of:
- ISE Serum High Standard
- ISE Serum Low Standard
- ISE Urine High Standard
- ISE Urine Low Standard
- ISE Buffer (contains Formaldehyde < 1.0w/v%, Phosphoric acid < 1.0w/v%, Triethanolamine < 2.0w/v%)
- Internal Standard
J. Substantial Equivalence Information:
1. Predicate device name(s):
ABX PENTRA Glucose HK CP (Pentra C400 Analyzer)
ISE reagents (DxC 700 AU Clinical Chemistry Analyzer)
DxC 700 AU Clinical Chemistry Analyzer
2. Predicate 510(k) number(s):
k081276
k161837
k161837
{3}
3. Comparison with predicate:
Similarities and Differences – Glucose reagent
| Item | Predicate Device
ABX Pentra Glucose HK CP
(k081276) | Candidate Device
Yumizen C1200 Glucose HK
(k183375) |
| --- | --- | --- |
| Intended use | For quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose hexokinase method by colorimetry. | Same |
| Method | Enzymatic method using hexokinase coupled with glucose-6-phosphate dehydrogenase | Same |
| Sample type | Serum, Plasma, Urine | Same |
| Reagent format | Liquid | Same |
| Reagent stability | Open: Stable for 55 days on board | Same |
| | Closed: Stable up to the expiry date on the label if stored at 2-8°C. | Same |
| Measuring Range – serum/plasma | 1.98 – 900.00 mg/dL | 1.8 – 630.0 mg/dL |
| Measuring Range – urine | 3.96 – 900.0 mg/dL | 8.5 – 630 .0 mg/dL |
| Automatic post-dilution | up to 2700 mg/dL | up to 2520 mg/dL |
Similarities and Differences – Sodium, Potassium and Chloride
| Item | Predicate Device
ISE reagents on DxC 700 AU Clinical Chemistry Analyzer (k161837) | Candidate Device
Sodium Electrode, Potassium Electrode, Chloride Electrode
(k183375) |
| --- | --- | --- |
| Intended use | For the quantitative determination of sodium, potassium and chloride concentrations in human serum, plasma, and urine. | Same |
| 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 |
| Sample Types | Serum, Plasma, Urine | Same |
| Measuring range | Serum and plasma: Cl 50 - 200 mmol/L | Same |
| | Urine Na 10 – 400 mmol/L | Same |
| | Urine Cl 15 – 400 mmol/L | Same |
| Measuring range | Serum/plasma Na 50 - 200 mmol/L | Na 100 - 200 mmol/L |
| | Serum/plasma K 1.0 – 10.0 mmol/L | K 1.5 – 10 mmol/L |
| | Urine K 2.0 – 200.0 mmol/L | K 2 – 300 mmol/L |
{4}
Similarities and Differences - Analyzer
| Item | Predicate Device
DxC 700 AU Clinical Chemistry Analyzer
(k161837) | Candidate Device
Yumizen C1200 (k183375) |
| --- | --- | --- |
| Intended Use | Automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. The system is for in vitro diagnostic use only. | Same |
| Throughput | Without ISE: 800 tests/h
With ISE: 1200 tests/h | Same |
| Sample volume | 1.0 to 25.0 μL | Same |
| Bar-code reader | Integrated | Same |
| Auto dilution feature | Yes | Same |
| Type of reagent | Liquid | Same |
| Sample type | Serum, Plasma, Urine, Cerebrospinal fluid (CSF) | Serum, Plasma, Urine |
| Sample capacity | 150 (15 racks × 10 samples) | 84 (2 Sample tray × 42 samples) |
| Total reaction volume | Min: 120 μL, Max: 350 μL | Min: 80 μL, Max: 430 μL |
| Wavelengths | 340 to 800 nm | 340 to 884 nm |
| | 13 wavelengths: 340, 380, 410, 450, 480, 520, 540, 570, 600, 660, 700, 750 and 800 nm (maximum of 2 wavelengths) | 14 wavelengths: 340, 410, 451, 478, 505, 545, 571, 596, 658, 694, 751, 805, 845 and 884 nm (maximum of 2 wavelengths) |
| Cuvette Material | Glass | Plastic |
| Dimensions (W x D x H) | 1250 × 890 mm × 1300 mm | 1220 × 850 × 1108 mm |
| Weight | 465 kg | 450 kg |
| Number of cuvettes | 165 | 231 |
K. Standard/Guidance Document Referenced (if applicable):
CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline-Third Edition.
CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline.
{5}
CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline-Second Edition.
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline.
CLSI EP25-A: Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline; Third Edition.
## L. Test Principle:
Glucose – Glucose in the sample is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (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.
Sodium/Potassium/Chloride – 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.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Precision studies were performed in accordance with CLSI EP05-A3.
Repeatability Precision – Glucose serum and urine
The sponsor evaluated the repeatability of the glucose method by analyzing two concentrations of control materials and five concentrations of patient samples for both serum and urine matrices. The data was collected using one instrument system and one reagent lot, and twenty replicates were collected per sample by one trained technician.
6
{6}
Results are summarized below:
| Sample | Serum | | Urine | |
| --- | --- | --- | --- | --- |
| | Mean | CV % | Mean | CV % |
| Control N | 91.91 | 1.1 | 23.85 | 0.5 |
| Control P | 275.02 | 0.7 | 294.27 | 0.6 |
| Sample 1 | 9.92 | 1.1 | 11.13 | 0.9 |
| Sample 2 | 30.80 | 0.9 | 17.07 | 1.0 |
| Sample 3 | 96.52 | 0.8 | 178.71 | 0.5 |
| Sample 4 | 272.07 | 0.8 | 353.08 | 0.8 |
| Sample 5 | 556.09 | 0.5 | 570.28 | 0.6 |
Total Precision - Glucose serum and urine
The sponsor evaluated the total precision of the glucose method by analyzing two concentrations of control materials and five concentrations of patient samples for both serum and urine matrices. The data was collected using three instrument systems and one reagent lot, and four replicates were collected per sample per day over 20 days by one trained technician.
Results are summarized below:
| Samples | Serum | | Urine | |
| --- | --- | --- | --- | --- |
| | Mean (mg/dL) | CV % | Mean (mg/dL) | CV % |
| Control N | 92.70 | 1.5 | 25.04 | 4.0 |
| Control P | 255.24 | 1.4 | 279.65 | 3.0 |
| Sample 1 | 12.65 | 2.3 | 11.87 | 3.6 |
| Sample 2 | 30.63 | 1.8 | 16.64 | 3.4 |
| Sample 3 | 103.56 | 1.7 | 174.80 | 3.2 |
| Sample 4 | 259.29 | 1.6 | 324.70 | 3.3 |
| Sample 5 | 571.87 | 1.6 | 537.47 | 4.3 |
Repeatability Precision - ISE Serum and Urine
The sponsor evaluated the repeatability of the sodium, potassium and chloride assays in serum by analyzing four levels of control materials and four levels of patient samples. Repeatability of the ISE methods in urine was evaluated by analyzing two levels of control materials and four levels of patient samples.
The data was collected using one instrument system and three reagent lots, and twenty replicates were collected per sample by three trained technicians.
{7}
Results from one representative lot are summarized below:
Serum
| Sample | Sodium | | Potassium | | Chloride | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean (mmol/L) | %CV | Mean (mmol/L) | %CV | Mean (mmol/L) | %CV |
| Control N | 134.68 | 0.2 | 4.336 | 0.2 | 115.47 | 0.3 |
| Control P | 135.37 | 0.2 | 6.689 | 0.3 | 114.5 | 0.2 |
| Control N2 | 123.1 | 0.2 | 3.865 | 0.3 | 91.7 | 0.3 |
| Control P2 | 155.18 | 0.2 | 6.567 | 0.3 | 112.17 | 0.3 |
| Sample 1 | 126.81 | 0.3 | 2.779 | 0.3 | 90.89 | 0.3 |
| Sample 2 | 139.61 | 0.3 | 4.067 | 0.3 | 102.29 | 0.4 |
| Sample 3 | 149.51 | 0.3 | 5.896 | 0.2 | 113.09 | 0.4 |
| Sample 4 | 165.83 | 0.3 | 6.742 | 0.3 | 130.35 | 0.3 |
Urine
| Sample | Sodium | | Potassium | | Chloride | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean (mmol/L) | %CV | Mean (mmol/L) | %CV | Mean (mmol/L) | %CV |
| Control N | 86.65 | 0.3 | 31.104 | 0.4 | 66.09 | 0.4 |
| Control P | 178.09 | 0.4 | 83.115 | 0.4 | 171.54 | 0.3 |
| Sample 1 | 28.36 | 1.2 | 29.176 | 0.3 | 30.78 | 2.2 |
| Sample 2 | 103.53 | 0.3 | 68.365 | 0.5 | 106.76 | 0.8 |
| Sample 3 | 186.54 | 0.3 | 118.05 | 0.4 | 190.33 | 0.6 |
| Sample 4 | 331.45 | 0.3 | 218.953 | 0.5 | 292 | 0.3 |
Total Precision - ISE serum and urine
The sponsor evaluated the total precision of the ISE methods by analyzing four concentrations of control materials and four concentrations of patient samples for both serum and urine matrices. The data was collected using three instrument systems and one reagent lot, and four replicates were collected per sample per day over 20 days by one trained technician. Results are summarized below:
| Serum Samples | Sodium | | Potassium | | Chloride | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean (mmol/L) | CV (%) | Mean (mmol/L) | CV (%) | Mean (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 |
{8}
9
| Urine Samples | Sodium | | Potassium | | Chloride | |
| --- | --- | --- | --- | --- | --- | --- |
| | Mean (mmol/L) | CV (%) | Mean (mmol/L) | CV (%) | Mean (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 |
b. Linearity/assay reportable range:
Linearity studies were performed in accordance with CLSI EP06-A guideline. Test samples spanning the claimed measuring ranges were prepared and analyzed for each analyte. The results of the linearity studies supported the claimed measuring ranges, as summarized below:
| Analyte / Matrix | Measuring Range |
| --- | --- |
| Glucose Serum / Plasma | 1.8 to 630 mg/dL |
| Glucose Urine | 8.5 to 630 mg/dL |
| Sodium Serum / Plasma | 100 to 200 mmol/L |
| Sodium Urine | 10 to 400 mmol/L |
| Potassium Serum / Plasma | 1.5 to 10 mmol/L |
| Potassium Urine | 3 to 300 mmol/L |
| Chloride Serum / Plasma | 52 to 200 mmol/L |
| Chloride Urine | 15 to 400 mmol/L |
The sponsor also performed a study to evaluate the auto-dilute feature available for serum and urine glucose measurements. The study protocol and acceptance criteria were reviewed and found to be acceptable. The results of the study supported the sponsor's claim that samples with glucose concentrations above 630 mg/dL can be diluted onboard the analyzer to obtain results up to 2520 mg/dL for serum, plasma and urine.
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The calibrators are traceable to commercially available reference materials for glucose, sodium, potassium, and chloride.
d. Detection limit:
The sponsor performed limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoQ) studies for the Glucose assay according to the CLSI EP17-A2 guideline. Results are summarized in the table below.
{9}
The sponsor chose to use $1.8\mathrm{mg / dL}$ as the lowest reportable value for serum and $8.5\mathrm{mg / dL}$ as the lowest reportable value for urine.
The sponsor performed LoQ studies for the ISE assays according to the CLSI EP17-A2 guideline. Samples at 11 different concentrations were analyzed in replicates of four over four days using two lots of reagent. The LoQ was defined as the highest concentration meeting the following total error goals: $7.0\%$ for serum sodium, $8.0\%$ for serum potassium, $7.4\%$ for serum chloride and $17.6\%$ for urine sodium, potassium and chloride.
Results are summarized in the table below.
| Parameter | LoQ |
| --- | --- |
| Serum/Plasma Sodium (mmol/L) | 32.05 |
| Urine Sodium (mmol/L) | 9.71 |
| Serum/Plasma Potassium (mmol/L) | 0.909 |
| Urine Potassium (mmol/L) | 0.258 |
| Serum/Plasma Chloride (mmol/L) | 22.59 |
| Urine Chloride (mmol/L) | 7.00 |
The upper and lower limits of the measuring range for the sodium, potassium and chloride assays are supported by the LoQ studies and the linearity studies (described under section M.2.b above).
# e. Analytical specificity:
Interference studies were performed according to the CLSI EP07-A2 guideline. Potential interferents were spiked into serum and urine sample pools and tested on the candidate device. The sponsor defined interference as a bias of $\geq 10\%$ . None of the compounds in the table below caused interference up to and including the concentrations listed.
| Serum Glucose | | Urine Glucose | |
| --- | --- | --- | --- |
| Hemoglobin | 501 mg/dL | Hemoglobin | 501 mg/dL |
| Triglycerides | 569 mg/dL | Total Bilirubin | 27.20 mg/dL |
| Total Bilirubin | 35.53 mg/dL | Ascorbic Acid | 5.98 mg/dL |
| Direct Bilirubin | 21.09 mg/dL | pH | 1.7 – 11.2 |
| Acetylsalicylic Acid | 65.16 mg/dL | Specific gravity | 1.000 - 1.030 |
| Ascorbic Acid | 5.98 mg/dL | | |
| Ibuprofen | 50.1 mg/dL | | |
| Acetaminophen | 20 mg/dL | | |
{10}
11
| Serum Sodium, Potassium, Chloride | | Urine Sodium, Potassium, Chloride | |
| --- | --- | --- | --- |
| 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 | Total 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 | | |
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Glucose
Serum and urine samples were tested using the Glucose HK reagent on the Yumizen C1200 and compared with the Pentra C400 Clinical Chemistry Analyzer. A single replicate was analyzed on both the candidate and comparator method. The equation for the regression line using the Passing Bablok method was obtained and is summarized below:
| Analyte | N | Intercept | Slope | Correlation (R²) |
| --- | --- | --- | --- | --- |
| Glucose in serum (mg/dL) | 141 | -2.453 | 1.005 | 0.996 |
| Glucose in urine (mg/dL) | 100 | 0.975 | 1.007 | 0.999 |
Sodium, Potassium, Chloride
Serum and urine samples were tested using the ISE module of the Yumizen C1200 and compared with the AU400 Analyzer. The equation for the linear regression analysis was obtained and is summarized below:
| Analyte | N | Intercept | Slope | Correlation (R²) |
| --- | --- | --- | --- | --- |
| Sodium in serum (mmol/L) | 165 | 1.371 | 0.987 | 0.995 |
| Sodium in urine (mmol/L) | 194 | -1.256 | 1.001 | 1.000 |
| Potassium in serum (mmol/L) | 170 | 0.023 | 0.994 | 0.999 |
{11}
| Analyte | N | Intercept | Slope | Correlation (R2) |
| --- | --- | --- | --- | --- |
| Potassium in urine (mmol/L) | 198 | -0.128 | 0.983 | 0.999 |
| Chloride in serum (mmol/L) | 172 | 0.818 | 0.992 | 0.998 |
| Chloride in urine (mmol/L) | 194 | 0.525 | 0.991 | 1.000 |
The sponsor also performed a second method comparison study to evaluate the performance of the candidate device when using lithium heparin plasma samples. For glucose, lithium heparin plasma samples were evaluated on the candidate device and the Pentra C400 analyzer with ABX Pentra Glucose HK reagent. For sodium, potassium, and chloride, lithium heparin plasma samples were evaluated on the candidate device and the Olympus AU400 Clinical Chemistry Analyzer. Results are summarized below:
| Analyte | N | Intercept | Slope | Correlation (R2) |
| --- | --- | --- | --- | --- |
| Glucose | 56 | -0.070 | 0.991 | 0.999 |
| Sodium | 171 | 0.200 | 1.000 | 0.997 |
| Potassium | 173 | 0.010 | 1.000 | 0.999 |
| Chloride | 173 | -1.568 | 1.019 | 0.998 |
b. Matrix comparison:
The performance of the device with serum and lithium heparin plasma samples was evaluated in the method comparison section above.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
{12}
13
5. Expected values/Reference range:
Glucose
Serum: 70 - 115 mg/dL
Urine: < 15 mg/dL
Sodium
Serum: 136 - 145 mmol/L
Urine: 40 - 220 mmol/day
Potassium
Serum: 3.5 - 5.1 mmol/L
Urine: 25 - 235 mmol/day
Chloride
Serum: 98 - 107 mmol/L
Urine: 110 - 250 mmol/day
References
Tietz NW, Clinical Guide for Laboratory Tests 3rd edition.
Walker HK, et al. Clinical Methods: The History, Physical, and Laboratory Examinations 3rd edition.
Thomas L. Clinical Laboratory Diagnostics. 1st edition.
N. Instrument Name:
Yumizen C1200
O. System Descriptions:
1. Modes of Operation:
Does the applicant’s device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ X or No ☐
Does the applicant’s device transmit data to a computer, webserver, or mobile device using wireless transmission?
Yes ☐ or No ☐ X
{13}
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X or No ☐
3. Specimen Identification:
Specimens are identified using the built-in barcode reader.
4. Specimen Sampling and Handling:
Instructions on specimen sampling and handling are provided in the reagent labeling.
5. Calibration:
Instructions on calibration are provided in the reagent labeling. For glucose, calibration stability is defined as 6 weeks, and users are instructed to recalibrate with every new reagent lot and when quality control values fall outside of the established ranges. For sodium, potassium, and chloride, users are instructed to calibrate daily, after maintenance, and after replacing the ISE Buffer, Internal Standard, electrode, or consumable items.
6. Quality Control:
The sponsor recommends that controls be assayed daily and/or after a calibration. The frequency of controls should correspond to laboratory guidelines and follow federal, state and local guidelines.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
Not applicable.
Q. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable.
R. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
14
