The BS-480/BS-490/CLC7201 chemistry analyzer is designed for clinical 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.
Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases 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 functions and other diseases associated with protein catabolism.
The BS-480/BS-490/CLC72i Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The UREA was cleared under K971309 and is the chosen assay to demonstrate performance for the photometric unit. The BS-480 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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured according to your request:
Description of the Device and Study:
The BS-480/BS-490/CLC720i Chemistry Analyzer is an automated clinical chemistry analyzer designed for in vitro photometric assays and includes an optional Ion-Selective Electrode (ISE) module. It measures Na+, K+, Cl- in serum, plasma, and urine samples, and Urea Nitrogen (BUN) in serum samples.
The study aimed to demonstrate substantial equivalence to the predicate device, the BS-400 Chemistry Analyzer (K112377). This was achieved by evaluating the performance of the BS-480, including its ISE module, across various metrics.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the performance metrics. Instead, it presents the performance characteristics of the BS-480 Chemistry Analyzer. For comparison, the correlation analysis refers to the BS-400 as the predicate, implying that performance should be comparable to or better than the predicate.
Below, I will list the performance data presented, which implicitly served as the "reported device performance" and was deemed acceptable for substantial equivalence.
Performance Characteristics of BS-480 Chemistry Analyzer
| Metric | Analyte | Unit | Reported Performance |
|---|---|---|---|
| Correlation Analysis | BUN | mg/dL | Slope: 0.9912, Intercept: 0.0494, Correlation Coefficient: 1.000 (Sample Range: 5.7-147.4, N=120) |
| (vs BS-400) | Serum Na+ | mmol/L | Slope: 0.9613, Intercept: 3.243, Correlation Coefficient: 0.998 (Sample Range: 101.3-197.1, N=132) |
| Serum K+ | mmol/L | Slope: 0.9570, Intercept: 0.0914, Correlation Coefficient: 1.000 (Sample Range: 1.35-7.34, N=120) | |
| Serum Cl- | mmol/L | Slope: 0.9537, Intercept: 4.216, Correlation Coefficient: 0.998 (Sample Range: 54.7-147, N=125) | |
| Urine Na+ | mmol/L | Slope: 0.9925, Intercept: -0.9291, Correlation Coefficient: 1.000 (Sample Range: 12-473, N=120) | |
| Urine K+ | mmol/L | Slope: 0.9677, Intercept: 0.6774, Correlation Coefficient: 1.000 (Sample Range: 5-192, N=120) | |
| Urine Cl- | mmol/L | Slope: 1.006, Intercept: 2.704, Correlation Coefficient: 1.000 (Sample Range: 16-396, N=120) | |
| Bias at Medical Decision Points | BUN | mg/dL | Point 1 (6): 0.00/-0.1%; Point 2 (26): -0.18/-0.7%; Point 3 (50): -0.39/-0.8% |
| Serum Na+ | mmol/L | Point 1 (115): -1.26/-1.1%; Point 2 (135): -2.0/-1.5%; Point 3 (150): -2.55/-1.7% | |
| Serum K+ | mmol/L | Point 1 (3.0): -0.038/-1.3%; Point 2 (5.8): -0.158/-2.7%; Point 3 (7.5): -2.31/-3.1% | |
| Serum Cl- | mmol/L | Point 1 (90): 0.05/0.1%; Point 2 (112): -0.97/-0.9% | |
| Urine Na+ | mmol/L | Point 1 (40): -1.2/-3.1%; Point 2 (112): -2.6/-1.2% | |
| Urine K+ | mmol/L | Point 1 (25): -0.1/-0.5%; Point 2 (125): -3.4/-2.7% | |
| Urine Cl- | mmol/L | Point 1 (110): 3.4/3.1%; Point 2 (250): 4.2/1.7% | |
| Preliminary Precision | BUN | mg/dL | CV% range: 0.4% - 1.0% across 6 pools |
| (Repeatability) | Serum Na+ | mmol/L | CV% range: 0.2% - 0.6% across 6 pools |
| Serum K+ | mmol/L | CV% range: 0.2% - 0.4% across 6 pools | |
| Serum Cl- | mmol/L | CV% range: 0.2% - 0.6% across 5 patient pools | |
| Urine Na+ | mmol/L | CV% range: 0.2% - 1.3% across 4 pools | |
| Urine K+ | mmol/L | CV% range: 0.0% - 1.3% across 4 pools | |
| Urine Cl- | mmol/L | CV% range: 0.4% - 1.5% across 4 pools | |
| Total Precision | BUN | mg/dL | Repeatability CV% range: 0.4% - 0.7%; Within-Device Precision CV% range: 1.7% - 1.8% (3 control pools, n=80 per pool) |
| Serum Na+ | mmol/L | Repeatability CV% range: 0.2% - 0.4%; Within-Device Precision CV% range: 0.6% - 0.8% (3 control pools, n=80 per pool) | |
| Serum K+ | mmol/L | Repeatability CV% range: 0.3% - 0.4%; Within-Device Precision CV% range: 0.7% - 0.9% (3 control pools, n=80 per pool) | |
| Serum Cl- | mmol/L | Repeatability CV% range: 0.3% - 0.5%; Within-Device Precision CV% range: 0.7% - 0.9% (3 control pools, n=80 per pool) | |
| Urine Na+ | mmol/L | Repeatability CV% range: 1.1% - 1.7%; Within-Device Precision CV% range: 1.8% - 2.9% (2 control pools, n=80 per pool) | |
| Urine K+ | mmol/L | Repeatability CV% range: 0.3% - 0.5%; Within-Device Precision CV% range: 0.8% - 1.5% (2 control pools, n=80 per pool) | |
| Urine Cl- | mmol/L | Repeatability CV% range: 0.6% - 1.2%; Within-Device Precision CV% range: 1.1% - 2.7% (2 control pools, n=80 per pool) | |
| Linearity | BUN | mg/dL | Slope: 1.0000, Intercept: -0.0109, Correlation Coefficient: 0.9992 (Tested Range: 5.1-165.1, Claimed Range: 5.5-151.7) |
| Serum Na+ | mmol/L | Slope: 1.0001, Intercept: -0.0073, Correlation Coefficient: 0.9999 (Tested Range: 69.1-250.2, Claimed Range: 100-200) | |
| Serum K+ | mmol/L | Slope: 1.0001, Intercept: -0.0005, Correlation Coefficient: 0.9998 (Tested Range: 0.85-9.76, Claimed Range: 1-8) | |
| Serum Cl- | mmol/L | Slope: 0.9999, Intercept: -0.0126, Correlation Coefficient: 0.9999 (Tested Range: 44.7-186.1, Claimed Range: 50-150) | |
| Urine Na+ | mmol/L | Slope: 1.0001, Intercept: -0.0461, Correlation Coefficient: 1.0000 (Tested Range: 10-614, Claimed Range: 10-500) | |
| Urine K+ | mmol/L | Slope: 1.0005, Intercept: -0.2565, Correlation Coefficient: 0.9997 (Tested Range: 4-230, Claimed Range: 5-200) | |
| Urine Cl- | mmol/L | Slope: 1.0000, Intercept: -0.2015, Correlation Coefficient: 0.9996 (Tested Range: 7-452, Claimed Range: 15-400) | |
| Detection Limits | BUN | mg/dL | LoB: 0.2, LoD: 0.3, LoQ: 4.8 |
| Serum Na+ | mmol/L | LoB: 3.7, LoD: 5.1, LoQ: 48.0 | |
| Serum K+ | mmol/L | LoB: 0.21, LoD: 0.24, LoQ: 0.69 | |
| Serum Cl- | mmol/L | LoB: 1.2, LoD: 3.7, LoQ: 36.6 | |
| Urine Na+ | mmol/L | LoB: 3, LoD: 4.5, LoQ: 10 | |
| Urine K+ | mmol/L | LoB: 1, LoD: 1.2, LoQ: 3.3 | |
| Urine Cl- | mmol/L | LoB: 1, LoD: 2.6, LoQ: 6.3 | |
| Interference (NSI) | BUN | mg/dL | Bilirubin: |
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.