(164 days)
The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination, and ion selective electrode.
The Glucose test system is for the quantitative measurement of glucose in human serum, plasma, urine and cerebrospinal fluid on Beckman Coulter AU analyzers. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemnia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
System reagent for the quantitative determination of C-Reactive Protein in human serum and plasma on Beckman Coulter AU Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be useful as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.
Reagents for the quantitative determination of Sodium, Potassium and Chloride concentrations in human serum, plasma and urine on the Beckman Coulter ISE modules.
The sodium test system is intended for the quantitative measurement sodium 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 test system is intended for the quantitative measurement of potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
The chloride test system is intended for the quantitative measurement of the level of chloride in plasma, serum, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Beckman Coulter DxC 700 AU Clinical Chemistry Analyzer carries out automated analysis of serum, plasma, urine samples and other body fluids and automatically generates results. The device is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only. Applications include colorimetric, latex agglutination and ion selective electrode. Electrolyte measurement is performed using a single cell Ion Selective Electrode (ISE) which is also common among the other members of the AU family.
The ISE module for Na*, K*, and Cl employs crown ether membrane electrodes for sodium and potassium and a molecular oriented PVC membrane for 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 Reference Solution, this electrical potential is translated into voltage and then into the ion concentration of the sample.
In this Beckman Coulter procedure, glucose 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 (G6P-DH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD+) to nicotinamide adenine dinucleotide, reduced (NADH).
The CRP Latex reagent is an in vitro diagnostic device that consists of ready to use buffer and latex particles coated with rabbit anti-CRP antibodies. Depending on the application used (different instrument settings), two measuring ranges are available: Normal application (CRP Concentrations ranging between 1.0-480 mg/L) and Highly Sensitive (Cardiac/ Neonatal) Application- (CRP concentrations ranging between 0.2- 80mg/L).
This document is a 510(k) Pre-Market Notification from Beckman Coulter for their DxC 700 AU Clinical Chemistry Analyzer and associated reagents (ISE Reagents, Glucose, and CRP Latex). This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness de novo. Therefore, the "acceptance criteria" and "proof" are focused on demonstrating substantial equivalence through comparative performance testing against a predicate device, rather than setting absolute performance thresholds for a novel device.
The study proves the device meets the acceptance criteria by showing its performance is comparable to the predicate device (AU5800 Clinical Chemistry Analyzer) across various analytical parameters.
Here's a breakdown of the information as requested, largely based on the provided text, while noting the differences that arise from a 510(k) submission's nature:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, the "acceptance criteria" are not absolute performance metrics but rather a demonstration that the new device performs similarly to or better than the predicate device. The goal is to show substantial equivalence. The tables below summarize the key performance parameters tested for the DxC 700 AU and its reagents against predicate devices/established guidelines. No explicit "acceptance criteria" values are stated in terms of thresholds, but meeting the "required specifications" (which would be internal to the manufacturer, often based on CLSI guidelines or clinical relevance) is implied by the "Pass" results.
| Study Type | Measured Parameter / Comparison | Performance Result (DxC 700 AU) |
|---|---|---|
| Method Comparison | Linearity, comparison to predicate AU5800 | Sodium, Serum: Slope: 1.007, Intercept: -0.779, r: 0.999 |
| Sodium, Urine: Slope: 1.014, Intercept: -1.392, r: 1.000 | ||
| Potassium, Serum: Slope: 0.988, Intercept: 0.048, r: 0.999 | ||
| Potassium, Urine: Slope: 1.011, Intercept: -0.149, r: 1.000 | ||
| Chloride, Serum: Slope: 0.999, Intercept: 0.224, r: 0.999 | ||
| Chloride, Urine: Slope: 1.036, Intercept: -3.679, r: 1.000 | ||
| Glucose Serum: Slope: 1.014, Intercept: 0.040, r: 1.000 | ||
| CRP Latex (HS) Serum: Slope: 1.013, Intercept: -0.050, r: 1.000 | ||
| All "met the required specifications" | ||
| Matrix Comparison | Glucose (EDTA, NaF-KOx, Li Heparin, NaF-EDTA vs Serum) | EDTA: Slope: 0.999, Intercept: -0.099, R: 0.998, Bias: -0.199 (Pass) |
| NaF-KOx: Slope: 1.007, Intercept: 0.127, R: 0.998, Bias: 0.827 (Pass) | ||
| Li Heparin: Slope: 0.996, Intercept: -0.076, R: 0.998, Bias: -0.476 (Pass) | ||
| NaF-EDTA: Slope: 1.005, Intercept: 0.133, R: 0.998, Bias: 0.633 (Pass) | ||
| Glucose Specification: Slope: 0.95-1.05; Intercept: ±3.8 mg/dL; R: ≥0.95; Bias: ±3% at 100 mg/dL | ||
| CRP Latex (HS) (EDTA, Li Heparin vs Serum) | EDTA: Slope: 0.990, Intercept: -0.059, R: 0.9992, Bias: -2.97 (Pass) | |
| Li Heparin: Slope: 0.985, Intercept: -0.013, R: 0.9995, Bias: -1.93 (Pass) | ||
| CRP Specification: Slope: 0.9-1.1; Intercept: ±0.2 mg/L; R: ≥0.95; Bias: ±6% at 3mg/L | ||
| Linearity/Reportable Range | Demonstrates linearity through claimed dynamic range | Sodium, Serum: Linear From 6.69 to 245.97 mEq/L |
| Sodium, Urine: Linear From 9.04 to 417.43 mEq/L | ||
| Potassium, Serum: Linear From 0.14 to 12.44 mEq/L | ||
| Potassium, Urine: Linear From 1.02 to 223.47 mEq/L | ||
| Chloride, Serum: Linear From 5.92 to 246.78 mEq/L | ||
| Chloride, Urine: Linear From 14.10 to 421.31 mEq/L | ||
| Glucose Serum: Linear From 5.20 to 843.18 mg/dL | ||
| CRP Latex (HS) Serum: Linear From 0.15 to 92.49 mg/L | ||
| Performance data "demonstrates linearity throughout the claimed dynamic range of each assay." | ||
| Sensitivity (Detection Limits) | LoB, LoD, LoQ comparison to claimed measuring range | Glucose, Serum: LoB: 0, LoD: 0.42, LoQ: 2.68 (claimed range: 10 mg/dL) |
| CRP Latex (HS), Serum: LoB: 0.04, LoD: 0.08, LoQ: 0.08 (claimed range: 0.2 mg/L) | ||
| All "met specifications and were below the claimed measuring range of the reagent." | ||
| Precision/Reproducibility | Within-run (Repeatability) & Within Laboratory (Total) Precision | Data provided for CRP Latex (HS), Glucose, Sodium, Potassium, Chloride (Serum & Urine) showing %CV and SD across multiple levels. |
| All "met the performance precision specifications." (See Table 9.5.1 in original document for full data) | ||
| In-Use & Cal. Stability | Reagent and ISE Stability Verification | CRP Latex (HS): Onboard Stability Claim 90 days, Calibration Stability Claim 90 days |
| Glucose: Onboard Stability Claim 30 days, Calibration Stability Claim 30 days | ||
| ISEs (Na, K, Cl): Calibration Stability Claim 1 day (Serum & Urine) | ||
| All results "were within specification and provide data to support the onboard and calibrations stability claims." | ||
| Interferences | LIH (Lipemia, Icterus, Hemolysis) Tolerance | Chloride: Bilirubin (unconjugated) 40 mg/dL (NSI), Hemoglobin 500 mg/dL (NSI), Lipemia 500 mg/dL (NSI) |
| Potassium: Bilirubin (unconjugated) 40 mg/dL (NSI), Hemoglobin 70 mg/dL (NSI), Lipemia 500 mg/dL (NSI) | ||
| Sodium: Bilirubin (unconjugated) 40 mg/dL (NSI), Hemoglobin 250 mg/dL (NSI), Lipemia 500 mg/dL (NSI) | ||
| Glucose: Lipemic (Intralipid) 700 mg/dL ( |
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium 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.(b)
Classification. Class II.