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510(k) Data Aggregation
(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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