Search Results
Found 1 results
510(k) Data Aggregation
(120 days)
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., <5-10% for clinical assays) | Control Pool 1: SD 0.33, CV% 3.0% (Mean 11.0)Control Pool 2: SD 0.94, CV% 2.0% (Mean 46.4) |
| Serum Na+ | mmol/L | Control Pool 1: SD 0.83, CV% 0.6% (Mean 136.1)Control Pool 2: SD 1.12, CV% 0.7% (Mean 166.1) | ||
| Serum K+ | mmol/L | Control Pool 1: SD 0.021, CV% 0.6% (Mean 3.72)Control Pool 2: SD 0.033, CV% 0.5% (Mean 6.10) | ||
| Serum Cl- | mmol/L | Control Pool 1: SD 0.38, CV% 0.4% (Mean 89.4)Control Pool 2: SD 0.44, CV% 0.4% (Mean 107.5) | ||
| Urine Na+ | mmol/L | Control Pool 1: SD 0.44, CV% 0.5% (Mean 87.1)Control Pool 2: SD 0.74, CV% 0.5% (Mean 148.6) | ||
| Urine K+ | mmol/L | Control Pool 1: SD 0.21, CV% 0.6% (Mean 35.1)Control Pool 2: SD 0.41, CV% 0.6% (Mean 68.8) | ||
| Urine Cl- | mmol/L | Control Pool 1: SD 0.40, CV% 0.4% (Mean 90.4)Control Pool 2: SD 0.48, CV% 0.4% (Mean 133.9) | ||
| Linearity | Slope close to 1, Intercept close to 0, R close to 1, claimed linear range within tested range. | BUN: Slope 0.9999, Intercept 0.0053, R=0.9996. Tested range 4.5-162.6 mg/dL, Claimed 5-150 mg/dLSerum Na+: Slope 0.9996, Intercept 0.0783, R=1.0000. Tested range 41.9-224.4 mmol/L, Claimed 100-200 mmol/LSerum K+: Slope 0.9997, Intercept -0.0003, R=0.9999. Tested range 0.61-9.34 mmol/L, Claimed 1-8 mmol/LSerum Cl-: Slope 0.9998, Intercept 0.0389, R=0.9999. Tested range 11.0-162.4 mmol/L, Claimed 50-150 mmol/LUrine Na+: Slope 1.0000, Intercept 0.0139, R=0.9999. Tested range 7.5-469.5 mmol/L, Claimed 10-400 mmol/LUrine K+: Slope 1.0001, Intercept 0.0175, R=0.9999. Tested range 3.1-254.4 mmol/L, Claimed 5-200 mmol/LUrine Cl-: Slope 1.0000, Intercept 0.0370, R=0.9999. Tested range 10.9-439.4 mmol/L, Claimed 15-400 mmol/L | ||
| Limits of Detection | LoD and LoQ values established. | BUN: LoB 0.4, LoD 0.9, LoQ 4.2 mg/dLSerum Na+: LoB 1.9, LoD 3.5, LoQ 39.5 mmol/LSerum K+: LoB 0.04, LoD 0.05, LoQ 0.54 mmol/LSerum Cl-: LoB 0.5, LoD 0.6, LoQ 9.5 mmol/LUrine Na+: LoB 0.9, LoD 1.4, LoQ 6.9 mmol/LUrine K+: LoB 0.1, LoD 0.2, LoQ 2.4 mmol/LUrine Cl-: LoB 0.2, LoD 0.3, LoQ 9.8 mmol/L | ||
| Interference | No significant interference (NSI) up to specified levels; identified significant interference (SI) clearly stated. | Bilirubin: NSI at 40 mg/dL for all tested analytes.Hemoglobin: NSI at 500 mg/dL for BUN, Serum Na+, Serum Cl-, Urine Na+, Urine K+, Urine Cl-. SI for Serum K+ at ≥250 mg/dL.Lipemia: NSI at 1000 mg/dL for all tested analytes.Ascorbic Acid: NSI at 30 mg/dL for all tested analytes.Potassium Thiocyanate: SI for Serum K+ (increase 0.55-0.58 mmol/L) and Chloride (increase 12.3-12.6 mmol/L). | ||
| Sample Type Equivalence (Serum vs. Plasma) | Na+ | mmol/L | High correlation, low bias. | Slope 1.000, Intercept -0.33, R=0.9989 (Na+)Slope 0.966, Intercept -0.13, R=0.9930 (K+)Slope 0.996, Intercept 0.62, R=0.9997 (Cl-) |
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison (Correlation with Predicate):
- BUN: 122 samples
- Serum Na+: 124 samples
- Serum K+: 121 samples
- Serum Cl-: 124 samples
- Urine Na+: 120 samples
- Urine K+: 120 samples
- Urine Cl-: 120 samples
- Total Precision: 80 measurements (n=80 typically means 80 results are obtained for each control pool for each analyte, likely over multiple runs/days).
- Linearity, Detection Limits, Interference, Sample Type Studies: Specific sample sizes are not explicitly stated for individual tests, but the data points represent multiple measurements at different concentrations. For sample type studies (Serum vs. Plasma), 51 samples were used.
Data Provenance: The document does not specify the country of origin of the data. The studies are described as "Performance testing," suggesting they are conducted to characterize the device's performance, which is typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. Clinical chemistry analyzers measure quantitative values of analytes. The "ground truth" for the test set is established by the reference method (the predicate device for method comparison, or known concentrations in linearity/control samples). There are no human experts used to establish a subjective "ground truth" in the way a diagnostic imaging device might require.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a quantitative measurement device, not one requiring expert review and adjudication for ground truth.
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 a clinical chemistry analyzer, not an AI-assisted diagnostic imaging device for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance studies described (precision, linearity, method comparison, detection limits, interference) are all "standalone" in the sense that they evaluate the analytical performance of the instrument itself, without human interpretation being part of the primary measurement. The device provides quantitative results directly.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth or reference for comparison were:
- Method Comparison: Measurements from the legally marketed predicate device, the Mindray BS-200 Chemistry Analyzer.
- Linearity: Known concentrations of prepared samples.
- Detection Limits: Calculations based on repetitive measurements of low-concentration samples and blanks.
- Interference: Known concentrations of interferents added to samples with known analyte concentrations.
- Sample Type Studies: Paired serum and plasma samples from patients, with the assumption that results should be highly correlated between the two matrices if the device functions correctly for both.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a "training set." It's a traditional in vitro diagnostic device for quantitative measurements.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (for AI) is described or used.
Ask a specific question about this device
Page 1 of 1