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510(k) Data Aggregation
(167 days)
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: <40, Hemoglobin: <500, Lipemia: <1000, Ascorbic acid: <30 |
| (No Significant Interference) | Serum Na+ | mmol/L | Bilirubin: <40, Hemoglobin: <500, Lipemia: <1000, Ascorbic acid: <30 |
| Serum K+ | mmol/L | Bilirubin: <40, Hemoglobin: / (not claimed due to hemolysis effect), Lipemia: <1000, Ascorbic acid: <30 | |
| Serum Cl- | mmol/L | Bilirubin: <40, Hemoglobin: <500, Lipemia: <1000, Ascorbic acid: <30 | |
| Urine Na+ | mmol/L | Bilirubin: <40, Hemoglobin: <500, Lipemia: <1000, Ascorbic acid: <30 | |
| Urine K+ | mmol/L | Bilirubin: <40, Hemoglobin: <125, Lipemia: <1000, Ascorbic acid: <30 | |
| Urine Cl- | mmol/L | Bilirubin: <40, Hemoglobin: <250, Lipemia: <1000, Ascorbic acid: <30 | |
| Drug Interference | All Analytes via phot. | / | No significant interference for Imipramine (0.15 mg/dL), Procainamide (15 mg/dL), Nortriptyline (0.23 mg/dL), Hydroxytyramine (50.4 mg/dL), Valproic acid (75.5 mg/dL), Chlorpromazine (6 mg/dL), Salicylic acid (70.5 mg/dL), Acetylsalicylic acid (1201 mg/dL), Erythromycin (7.1 mg/dL), Ethosuximide (30.5 mg/dL), Acetaminophen (242 mg/dL), Ampicillin (6 mg/dL) |
| Significant Drug Interference | Serum K+ | mmol/L | Ibuprofen (506 mg/dL): Decreases K+ by 0.5 mmol/L (at 3.25 mmol/L) and 0.59 mmol/L (at 5.39 mmol/L) |
| Serum Cl- | mmol/L | Ibuprofen (380 mg/dL): Increases Cl- by 15.4 mmol/L (at 99 mmol/L) and 14.6 mmol/L (at 119.3 mmol/L) | |
| Serum Na+ | mmol/L | Benzalkonium Chloride (7.7 mg/dL): Increases Na+ by 21.5 mmol/L (at 130.5 mmol/L) and 17.4 mmol/L (at 146.1 mmol/L) | |
| Serum K+ | mmol/L | Benzalkonium Chloride (5.2 mg/dL): Increases K+ by 0.38 mmol/L (at 2.97 mmol/L) | |
| Serum K+ | mmol/L | Potassium thiocyanate (6.1 mg/dL): Increases K+ by 0.71 mmol/L (at 2.97 mmol/L) and 0.65 mmol/L (at 5.08 mmol/L) | |
| Serum Cl- | mmol/L | Potassium thiocyanate (12.2 mg/dL): Increases Cl- by 13.4 mmol/L (at 90.1 mmol/L) and 14.4 mmol/L (at 111.2 mmol/L) | |
| Sample Type Conversion | Na+ | mmol/L | Slope: 0.971, Intercept: 2.9, Correlation Coefficient: 0.995 (N=67, Range: 103.2-185.5) |
| (Serum vs Plasma) | K+ | mmol/L | Slope: 0.974, Intercept: -0.17, Correlation Coefficient: 0.992 (N=67, Range: 1.2-6.9) |
| Cl- | mmol/L | Slope: 1.005, Intercept: -0.1, Correlation Coefficient: 0.995 (N=67, Range: 70.4-143.2) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Correlation Analysis (vs Predicate BS-400):
- BUN: N=120
- Serum Na+: N=132
- Serum K+: N=120
- Serum Cl-: N=125
- Urine Na+: N=120
- Urine K+: N=120
- Urine Cl-: N=120
- Preliminary Precision Test: 6 pools for BUN, Serum Na+, Serum K+; 5 patient pools for Serum Cl-; 4 pools each for Urine Na+, Urine K+, Urine Cl-. The 'N' for each pool is not explicitly stated, but typically this would involve multiple replicates per pool.
- Total Precision Test: N=80 per control pool for all analytes (BUN, Serum Na+, Serum K+, Serum Cl- had 3 pools each; Urine Na+, Urine K+, Urine Cl- had 2 pools each).
- Linearity Test: The number of samples/measurements used to establish linearity is not explicitly stated. The range tested and claimed linear range are provided.
- Detection Limit Studies: The 'N' for these studies (LoB, LoD, LoQ) is not explicitly stated.
- Interference Test: The 'N' for these studies is not explicitly stated, but concentrations of various interferents were tested.
- Drug Interference Test (No Significant Interference): The 'N' for these studies is not explicitly stated, but various drug levels were tested.
- Significant Drug Interference Test: The 'N' for these studies is not explicitly stated, but specific drug levels and their observed effects are detailed.
- Sample Type Studies (Serum vs Plasma): N=67
- Data Provenance: Not explicitly stated. The submitting company is from China (Shenzhen Mindray Bio-medical Electronics Co., LTD), but the origin of the clinical samples is not specified. It is likely a retrospective study using collected samples, given the assay nature.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This type of device (clinical chemistry analyzer) does not typically involve human experts establishing "ground truth" in the same way an imaging or diagnostic AI device would. The "ground truth" for quantitative measurements like BUN, Na+, K+, Cl- is established by:
- Using reference methods or predicate devices (as implied by the correlation study with the BS-400).
- Using calibrators and controls with known, traceable values.
- The analytical accuracy of the methods themselves.
Therefore, the concept of "number of experts" and "qualifications of those experts" does not directly apply here as it would for image interpretation or diagnosis. The "experts" are more akin to the laboratory scientists and statisticians who design and execute the validation studies and verify the analytical performance.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers are interpreting data (like imaging studies) and disagreements need to be resolved to establish ground truth.
For a clinical chemistry analyzer, the "ground truth" is determined by the analytical performance of the reference method or predicate device. There is no mention of an adjudication process for this type of test result.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting cases and is typically used for diagnostic devices where human interpretation is a key component, often comparing human performance with and without AI assistance. This document describes the analytical performance of an automated chemical analyzer, which does not involve human interpretation in the same manner.
6. If a Standalone Study (Algorithm Only Without Human-in-the-loop Performance) Was Done
Yes, this entire submission effectively describes a standalone performance study of the BS-480/BS-490/CLC720i Chemistry Analyzer. The study evaluates the device's ability to accurately measure analytes independently, without requiring human-in-the-loop performance correction or assistance in the measurement process itself. The "algorithm" here is the instrument's internal measurement and calculation processes.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Reference measurements from a legally marketed predicate device (BS-400 Chemistry Analyzer), as indicated by the "Correlation Analysis" section where the BS-480's results are compared to the BS-400's results.
- Known concentrations in control and calibration materials for linearity, precision, and detection limit studies.
- Spiked samples with known concentrations of interferents for interference studies.
This is considered analytical ground truth, established through comparison to validated methods and known standards, rather than expert consensus, pathology, or outcomes data, which are more common for diagnostic accuracy studies.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning. This submission is for an automated clinical chemistry analyzer, which functions based on established chemical and physical principles, not a machine learning algorithm that requires a training set to "learn" patterns. The device operates deterministically.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and its associated ground truth establishment is not applicable to this device type as described in the document.
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