(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: |
§ 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.