The BS-800M/ABS800/BA-800M Chemistry Analyzer is designed for clinical chemistry laboratory use, making direct quantitative measurements of Na+(sodium), K+(potassium), Cl- (chloride) in serum, plasma and urine samples, and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction.
The BS-800M/ABS800/BA-800M ISE Kit is for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum, plasma and urine samples on the The BS-800M/ABS800/BA-800M Chemistry Analyzer.
Sodium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by, low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders.
Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney function and other diseases associated with protein catabolism.
The BS-800M/BA-800M/ABS800 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The BUN (LIQUID) REAGENT SET was cleared under K972671 and is the chosen assay to demonstrate performance for the photometric unit. The BS-800M Chemistry Analyzer has an optional Ion-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.
The provided text describes a 510(k) premarket notification for the BS-800M/ABS800/BA-800M Chemistry Analyzer and its associated ISE Kit. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, the BS-200 Chemistry Analyzer.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in the document. Instead, the study aims to show substantial equivalence through correlation with a predicate device and present performance characteristics (precision, linearity, detection limits, interference). For correlation, the acceptance is implied by a high correlation coefficient and relatively low bias. For other performance metrics, the reported values are the acceptance.
| Performance Metric | Analyte | Unit | Acceptance Criteria (Implied) | Reported Device Performance (BS-800M) |
|---|---|---|---|---|
| Correlation with Predicate Device (BS-200) | High correlation coefficient (close to 1), low bias at medical decision points comparing to predicate. | BUN: Slope 0.98, Intercept 0.81, R=0.9997. Bias at MD: 0.696/11.6% (6), 0.317/1.2% (26), -0.138/-0.3% (50) | ||
| Serum Na+: Slope 1.03, Intercept -5.95, R=0.9966. Bias at MD: -2.713/-2.4% (115), -2.149/-1.6% (135), -1.727/-1.2% (150) | ||||
| Serum K+: Slope 1.04, Intercept -0.09, R=0.9994. Bias at MD: 0.032/1.1% (3.0), 0.144/2.5% (5.8), 0.212/2.8% (7.5) | ||||
| Serum Cl-: Slope 1.00, Intercept 0.15, R=0.9993. Bias at MD: 0.245/0.3% (90), 0.267/0.2% (112) | ||||
| Urine Na+: Slope 0.99, Intercept -2.52, R=0.9997. Bias at MD: -2.759/-6.9% (40), -3.837/-1.7% (112) | ||||
| Urine K+: Slope 0.98, Intercept -1.00, R=0.9997. Bias at MD: -1.418/-5.7% (25), -3.085/-2.5% (125) | ||||
| Urine Cl-: Slope 0.97, Intercept 2.06, R=0.9988. Bias at MD: -1.112/-1.0% (110), -5.147/-2.1% (250) | ||||
| Total Precision (Within-Device) | BUN | mg/dL | Low CV% (e.g., |
§ 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.