(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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ZHENG ZHE ENGINEER OF TECHNICAL REGULATION DEPARTMENT MINDRAY BUILDING, KEJI 12TH RD SOUTH, HI-TECH INDUSTRIAL PARK, NANSHAN, SHENZHEN, 518057 P.R. CHINA
June 9, 2016
Re: K160370
Trade/Device Name: BS-800M/ ABS800/BA-800M ISE KIT BS-800M Chemistry Analyzer BA-800M Chemistry Analyzer ABS-800 Chemistry Analyzer
Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium Test System Regulatory Class: II Product Code: JGS, CGZ, CGZ, CEM, CDQ, JJE Dated: April 15, 2016 Received: May 2, 2016
Dear Zeng Zhe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For:
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160370
Device Name
BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer, BS-800M/ABS800/BA-800M ISE Kit
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
The assigned 510(k) number is: K160370
Submitter:
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
Tel: +86 755 2658 2888 Fax: +86 755 2658 2680
● Contact Person:
Zeng Zhe
Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China
● Date Prepared:
June 2, 2016
Name of the device:
- Trade/Proprietary Name:
BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer, BS-800M/ABS800/BA-800M ISE Kit (BS-800M, BA-800M and ABS800 are the same analyzers except the appearance, logo and name of the models. For convenience of explanation, the BS-800M Chemistry Analyzer is
represented of the three in this summary.)
- Common Name: Clinical Chemistry Analyzer (with optional ISE Module)
- Classification Number/Class: ●
75JJE, Class I 75CDQ, Class II
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75CEM, Class II 75CGZ, Class II 75JGS, Class II
Legally Marketed Predicate Device:
BS-200 Chemistry Analyzer, SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
K972671 BUN (LIQUID) REAGENT SET, POINTE SCIENTIFIC, INC.
Description:
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.
Intended Use/ Indication for Use:
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.
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Comparison of Technological Characteristics:
Substantial equivalence has been demonstrated between the BS-800M Chemistry Analyzer and BS-200 Chemistry Analyzer. Both of them utilize absorbance photometry to perform and output quantitative results for kinetic and endpoint clinical chemistries. For analytes, BS-800M Chemistry Analyzer and BS-200 Chemistry Analyzer determine the concentration of unknown samples from a standard curve generated with known analyte concentrations. The BS-800M Chemistry Analyzer and BS-200 Chemistry Analyzer both utilize Ion-Selective Electrodes technology to measures the concentration of the electrolytes, sodium, potassium, and chloride in samples.
| ComparisonSection | BS-800M | BS-200(Predicate Device) | |
|---|---|---|---|
| 510(K) Number | K160370 | K072018 | |
| Intended use | The BS-800M/ABS800/BA-800MChemistry Analyzer is designed forclinical chemistry laboratory use,making direct quantitativemeasurements of Na+(sodium), K+(potassium), Cl- (chloride) in serum,plasma and urine samples, and UreaNitrogen in serum samples.Additionally, other variouschemistry tests may be adaptable tothe analyzer depending on thereagent used to induce a photometricreaction. | The BS-200 Chemistry Analyzer isdesigned for clinical laboratory use,making direct quantitativemeasurements of Na+ (sodium), K+(potassium), Cl-(chloride) in serum,plasma and urine samples andGlucose in serum samples.Additionally, other variouschemistry assays may be adaptableto the analyzer depending on thereagent used to induce a photometricreaction. | |
| Parameter(photometric) | BUN | BUN | |
| Parameter(ion selectiveelectrode) | Na+, K+, Cl⁻ | Na+, K+, Cl⁻ | |
| Comparison on photometric assay Chart 1: BS-800M and BS-200 analyzer | |||
| Feature | BS-800M | BS-200(Predicate Device) | Same(S)/Different(D) |
| 510(K) | K160370 | K072018 | / |
Comparison Table of BS-800M and Predicate Device:
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| 1 | System Function | ||||
|---|---|---|---|---|---|
| System Control | Automatic, computer controlled | Automatic, microprocessor controlled | S | ||
| LIS external connectivity capability | Yes | Yes | S | ||
| Calibration/QC | Automatic and Manual calibration/QC | Automatic and Manual calibration/QC | S | ||
| Barcode | Yes | Yes | S | ||
| 2 | Throughput (Max) | ||||
| 800 photometric tests per hour1200 tests per hour with ISE | 200 photometric tests per hour330 tests per hour with ISE | D | |||
| 3 | Configuration | ||||
| Analyzing unit, the Rack Feeder System, Operation unit, Output unit | Analytical unit, Operation unit, Output unit | D | |||
| 4 | Principle of Analysis | ||||
| Mode of detection | Photometric | Photometric | S | ||
| Analytical methods | EndpointFixed-timeKinetic | EndpointFixed-timeKinetic | S | ||
| Calibration methods | Linear calibration and nonlinear calibration | Linear calibration and nonlinear calibration | S | ||
| 5 | Optical Measurement Unit | ||||
| Measurement Modes | Absorbance | Absorbance | S | ||
| Optical Modes | Monochromatic, Bichromatic | Monochromatic, Bichromatic | S | ||
| Photometer | Multi-wavelength, diffraction grating spectrophotometer | Multi-wavelength, Light transmission mode of the filter | D | ||
| Wavelength | 340nm, 380nm, 412nm, 450nm, 505nm, 546nm, 570nm, 605nm, 660nm, 700nm, 740nm and 800nm | 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm | D | ||
| Linear absorbance range | 0-3.4 absorbance | 0-4.0 absorbance | D | ||
| Light Source | Tungsten halogen lamp | Tungsten halogen lamp | S | ||
| Detector | Photodiode | Photodiode | S | ||
| 6 | Reaction Unit | ||||
| Reaction cuvettes | Glass, 165 non-disposable | Plastic, 80 disposable | D | ||
| Reaction volume | $100{\text{\textasciitilde}}360\mu L$ | $180{\text{\textasciitilde}}500\mu L$ | D | ||
| Optical path | 5mm | 5mm | S | ||
| Reaction temperature | 37°C | 37°C | S | ||
| 7 | Sample and Reagent System | ||||
| Sample disk | 140 positions. 45 positionsrespectively for outer twocircles of outer rings and 25positions respectively forinter two circles of interrings | 40 sample tube positions onthe outer circle | D | ||
| Reagent disk | 120 positions. 50 positionsfor inner circle and 70positions for outer circle. | 40 reagent bottle positionson the inner circle | D | ||
| Pipttor System | Positive displacementstepper motordrive | Positive displacementstepper motor drive | S | ||
| Refrigerator temperature | 2-8°C | 4-15°C | D | ||
| Sample Dispense | $1.5\mu L -50\mu L$ | $3\mu L -45\mu L$ | D | ||
| Reagent Dispense | $15\mu L-300\mu L$ | $30\mu L-450\mu L$ | D | ||
| 8 | POWER | ||||
| Input | $110/115V{\text{\textasciitilde}}\pm 10%, 60Hz\pm 1$Hz | $100-130V{\text{\textasciitilde}},50/60\pm 1 Hz$ | D | ||
| Consumption | 3800VA | 1000 VA | D | ||
| 9 | Operating environmental conditions | ||||
| Temperature | 15°C to 30°C | 15°C to 30°C | S | ||
| Humidity | 35% to 85%,non-condensing | 35% to 80%,non-condensing | S | ||
| Comparison on Electrolytes assay Chart 2: BS-800M ISE module and BS-200 ISE module | |||||
| Feature | BS-800M ISE Kit | BS-200 ISE Kit (PredicateDevice) | Same(S)/Different(D) | ||
| 510(K) | K160370 | K072018 | / | ||
| 1 | Indication for use/Intended Use | ||||
| ISE Kit | The BS-800M/ ABS800/BA-800M ISE Module isfor the in vitro quantitativedetermination of Sodium | The BS-200 ISE Module isfor the in vitro quantitativedetermination of Sodium(Na⁺), Potassium (K⁺), and | S | ||
| (Na+), Potassium (K+), andChloride (Cl-)concentrations in serum,plasma and urine sampleson the the BS-800M/ABS800/BA-800MChemistry Analyzer. | Chloride (Cl-)concentrations in serum,plasma and urine sampleson the the BS-200Chemistry Analyzer. | ||||
| Sodium | Sodium measurementsmonitor electrolyte balanceand in the diagnosis andtreatment of diseasesinvolving electrolyteimbalance. | Sodium measurementsmonitor electrolyte balanceand in the diagnosis andtreatment of diseasesinvolving electrolyteimbalance. | S | ||
| Potassium | Potassium measurementsmonitor electrolyte balanceand in the diagnosis andtreatment of diseaseconditions characterized by,low or high blood potassiumlevels. | Potassium measurementsmonitor electrolyte balanceand in the diagnosis andtreatment of diseaseconditions characterized by,low or high blood potassiumlevels. | S | ||
| Chloride | Chloride measurements areused in the diagnosis andtreatment of electrolyte andmetabolic disorders. | Chloride measurements areused in the diagnosis andtreatment of electrolyte andmetabolic disorders. | S | ||
| 2 | System Function | ||||
| Method Principle | Ion Selective Electrode | Ion Selective Electrode | S | ||
| Electrode | Na+ electrode, K+electrode, Cl- electrode,reference electrode | Na+ electrode, K+electrode, Cl- electrode,reference electrode, Spaceelectrode | D | ||
| Reference reagent | MR Serum Standard, MRUrine Standard, MR BufferSolution, MR DetergentSolution, MR Na/K CheckSolution | Reagent Pack, UrineDiluent, Cleaning Solution, | D | ||
| ISE InternalStandard | None | None | S | ||
| Sample Volume | 22 µL total for all three tests | 70 µL Serum, plasma mode;140 µL Urine mode | D | ||
| ISE ThroughputRate | 600 tests/hour | 300 tests/hour Serum,plasma mode; | D | ||
| Test Environment | 198 tests/hour Urine modeClinical Lab | S | |||
| 3 | Calibration | ||||
| Calibrator | MR Serum Standard forSerum, Plasma mode;MR Urine standard forUrine mode; | ISE reagent pack for allthree sample types | D | ||
| Standardization | Na: NIST standard materialSRM919K: NIST standard materialSRM 918Cl: NIST standard materialSRM 919 | Na: NIST standard materialSRM956K: NIST standard materialSRM 956Cl: NIST standard materialSRM 956 | D | ||
| Calibrator Stability | 5°C~35°C, 12 months ofshelf-life, 8 weeks of in-usestability | 4°C~25°C, 24 months ofshelf-life | D | ||
| Calibrator Matrix | Buffered Aqueous matrix | Buffered Aqueous matrix | S | ||
| Calibrator Form | liquid | liquid | S | ||
| Number ofCalibrator levels | Two for serum/Plasma andTwo for Urine | Two for serum/plasma/urine | S | ||
| CalibrationFrequency | Daily | 8 hours | D | ||
| 4 | Performance Characters | ||||
| AnalyticalMeasuring(mmol/L) | Serum/PlasmaNa: 100-200K: 1-8Cl: 50-150UrineNa: 10-400K: 5-200Cl: 15-400 | Serum/PlasmaNa: 113-194K: 1.1-8.6Cl: 53-154UrineNa: 27-372K: 13-184Cl: 42-422 | D | ||
| Reference Interval | Serum(Adults):Sodium: 136-145 mmol/LPotassium: 3.5-5.1 mmol/LChloride: 98-107 mmol/LPlasma(Adults):Sodium: 136-145 mmol/LPotassium: 3.4-4.5 mmol/LChloride: 98-107 mmol/LUrine. 24 hour (Adults): | Serum(Adults):Sodium: 136-145 mmol/LPotassium: 3.5-5.1 mmol/LChloride: 98-107 mmol/LPlasma(Adults):Sodium: 136-145 mmol/LPotassium: 3.4-4.5 mmol/LChloride: 98-107 mmol/LUrine. 24 hour (Adults): | S |
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| Sodium: 40-220 mmol/24h | Sodium: 40-220 mmol/24h | ||
|---|---|---|---|
| Potassium:25-125 mol/24h | Potassium:25-125 mol/24h | ||
| Chloride:110-250 mol/24h | Chloride:110-250 mol/24h | ||
| NSI Interferencesconcentration | Bilirubin | Bilirubin | D |
| Na/K/Cl for three sample | Na/K/Cl for three sample | ||
| types: 40 mg/dL | types: 20 mg/dL | ||
| Hemoglobin | Hemoglobin | ||
| Na/Cl for three sample | Na/K/Cl for three sample | ||
| types: 500 mg/dL | types: 500 mg/dL | ||
| Urine K: 500 mg/dL | |||
| Lipemia | |||
| Lipemia | Na/K/Cl for three sample | ||
| Na/K/Cl for three sample | types: 1000 mg/dL | ||
| types: 1000 mg/dL | |||
| Ascorbic acid | |||
| Na/K/Cl for three sample | |||
| types: 30 mg/dL |
Performance Characteristics:
Performance testing of the BS-800M Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-800M to evaluate precision, linearity, and method comparison, Limits of Detection and Limits of Quantitation, interference, ISE plasma sample type studies.
A correlation analysis between the BS-800M Chemistry Analyzer and BS-200 Chemistry Analyzer yielded the following results:
| Analyte | Unit | SampleRange | N | Slope | Intercept | CorrelationCoefficient |
|---|---|---|---|---|---|---|
| BUN | mg/dL | 5.4-149.5 | 122 | 0.98 | 0.81 | 0.9997 |
| Serum Na+ | mmol/L | 100.2-196.4 | 124 | 1.03 | -5.95 | 0.9966 |
| Serum K+ | mmol/L | 1.40-7.70 | 121 | 1.04 | -0.09 | 0.9994 |
| Serum Cl- | mmol/L | 50.4-149.4 | 124 | 1.00 | 0.15 | 0.9993 |
| Urine Na+ | mmol/L | 12.1-395.4 | 120 | 0.99 | -2.52 | 0.9997 |
| Urine K+ | mmol/L | 5.1-194.7 | 120 | 0.98 | -1.00 | 0.9997 |
| Urine Cl- | mmol/L | 15.2-381.3 | 120 | 0.97 | 2.06 | 0.9988 |
And the bias at the medical decision points of method comparison yielded the following
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| Analyte | Unit | Medical decision points | Bias at the medical decision points(Difference/Difference%) | ||
|---|---|---|---|---|---|
| Point 1 | Point 2 | Point 3 | |||
| BUN | mg/dL | 6,26,50 | 0.696/11.6% | 0.317/1.2% | -0.138/-0.3% |
| Serum Na+ | mmol/L | 115,135,150 | -2.713/-2.4% | -2.149/-1.6% | -1.727/-1.2% |
| Serum K+ | mmol/L | 3.0,5.8,7.5 | 0.032/1.1% | 0.144/2.5% | 0.212/2.8% |
| Serum Cl- | mmol/L | 90,112 | 0.245/0.3% | 0.267/0.2% | / |
| Urine Na+ | mmol/L | 40,112 | -2.759/-6.9% | -3.837/-1.7% | / |
| Urine K+ | mmol/L | 25,125 | -1.418/-5.7% | -3.085/-2.5% | / |
| Urine Cl- | mmol/L | 110,250 | -1.112/-1.0% | -5.147/-2.1% | / |
results:
The total precision test of BS-800M yielded the following results:
| Analyte | Unit | Sample | n | Mean | Repeatability | Within-DevicePrecision | ||
|---|---|---|---|---|---|---|---|---|
| SD | CV% | SD | CV% | |||||
| BUN | mg/dL | Controlpool 1 | 80 | 11.0 | 0.28 | 2.5% | 0.33 | 3.0% |
| mg/dL | Controlpool 2 | 80 | 46.4 | 0.57 | 1.2% | 0.94 | 2.0% | |
| Serum Na+ | mmol/L | Controlpool 1 | 80 | 136.1 | 0.35 | 0.3% | 0.83 | 0.6% |
| mmol/L | Controlpool 2 | 80 | 166.1 | 0.46 | 0.3% | 1.12 | 0.7% | |
| Serum K+ | mmol/L | Controlpool 1 | 80 | 3.72 | 0.006 | 0.2% | 0.021 | 0.6% |
| mmol/L | Controlpool 2 | 80 | 6.10 | 0.013 | 0.2% | 0.033 | 0.5% | |
| Serum CL- | mmol/L | Controlpool 1 | 80 | 89.4 | 0.21 | 0.2% | 0.38 | 0.4% |
| mmol/L | Controlpool 2 | 80 | 107.5 | 0.23 | 0.2% | 0.44 | 0.4% |
Page 9 of 14
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| pool 2 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Urine Na+ | mmol/L | Controlpool 1 | 80 | 87.1 | 0.22 | 0.3% | 0.44 | 0.5% |
| Urine Na+ | mmol/L | Controlpool 2 | 80 | 148.6 | 0.36 | 0.2% | 0.74 | 0.5% |
| Urine K+ | mmol/L | Controlpool 1 | 80 | 35.1 | 0.08 | 0.2% | 0.21 | 0.6% |
| Urine K+ | mmol/L | Controlpool 2 | 80 | 68.8 | 0.16 | 0.2% | 0.41 | 0.6% |
| Urine Cl- | mmol/L | Controlpool 1 | 80 | 90.4 | 0.20 | 0.2% | 0.40 | 0.4% |
| Urine Cl- | mmol/L | Controlpool 2 | 80 | 133.9 | 0.17 | 0.1% | 0.48 | 0.4% |
The linearity test of BS-800M yielded the following results:
| Analyte | Unit | Slope | Intercept | CorrelationCoefficient | Linear RangeTested | ClaimedLinearRange |
|---|---|---|---|---|---|---|
| BUN | mg/dL | 0.9999 | 0.0053 | 0.9996 | 4.5-162.6 | 5-150 |
| SerumNa+ | mmol/L | 0.9996 | 0.0783 | 1.0000 | 41.9-224.4 | 100-200 |
| SerumK+ | mmol/L | 0.9997 | -0.0003 | 0.9999 | 0.61-9.34 | 1-8 |
| SerumCl- | mmol/L | 0.9998 | 0.0389 | 0.9999 | 11.0-162.4 | 50-150 |
| UrineNa+ | mmol/L | 1.0000 | 0.0139 | 0.9999 | 7.5-469.5 | 10-400 |
| Urine K+ | mmol/L | 1.0001 | 0.0175 | 0.9999 | 3.1-254.4 | 5-200 |
| UrineCl- | mmol/L | 1.0000 | 0.0370 | 0.9999 | 10.9-439.4 | 15-400 |
The detection limit studies test of BS-800M yielded the following results:
| Analyte | Unit | LoB | LoD | LoQ |
|---|---|---|---|---|
| BUN | mg/dL | 0.4 | 0.9 | 4.2 |
| Serum Na+ | mmol/L | 1.9 | 3.5 | 39.5 |
| Serum K+ | mmol/L | 0.04 | 0.05 | 0.54 |
Page 10 of 14
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| Serum Cl- | mmol/L | 0.5 | 0.6 | 9.5 |
|---|---|---|---|---|
| Urine Na+ | mmol/L | 0.9 | 1.4 | 6.9 |
| Urine K+ | mmol/L | 0.1 | 0.2 | 2.4 |
| Urine Cl- | mmol/L | 0.2 | 0.3 | 9.8 |
The Interference test of BS-800M yielded the following results:
Effects of bilirubin, hemoglobin, lipemia, ascorbic acid are tested, yielded the following results:
| Analyte | Analyteconcentration(mmol/L) | Bilirubinlevel(mg/dL) | Bias(mmol/L) | Comments |
|---|---|---|---|---|
| BUN | 8.539.5 | 40 | +0.0-0.1 | NSI |
| Serum Na+ | 134.0154.8 | 40 | -0.4+0.4 | NSI |
| Serum K+ | 3.235.94 | 40 | -0.01+0.00 | NSI |
| Serum Cl- | 89.7114.7 | 40 | -0.1-0.2 | NSI |
| Urine Na+ | 45.9224.1 | 40 | +0.6-1.3 | NSI |
| Urine K+ | 26.9127.3 | 40 | +0.0-0.4 | NSI |
| Urine Cl- | 113.9253.5 | 40 | +0.1-1.5 | NSI |
| Results of the bilirubin interference testing | ||
|---|---|---|
Results of the hemoglobin interference testing
| Analyte | Analyte concentration (mmol/L) | Hemoglobin level(mg/dL) | Bias(mmol/L) | Comments |
|---|---|---|---|---|
| BUN | 8.640.0 | 500 | +0.4-0.1 | NSI |
| Serum Na+ | 129.4153.1 | 500 | +0.9+0.9 | NSI |
| Serum K+ | 3.15 | 125 | +0.30 | NSI |
| ≥250 | +0.61 | SI | ||
| Serum K+ | 5.81 | 125 | +0.33 | NSI |
| ≥250 | +0.68 | SI |
Page 11 of 14
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| Serum Cl- | 88.8113.5 | 500 | +2.0+2.6 | NSI |
|---|---|---|---|---|
| Urine Na+ | 45.1223.4 | 500 | +1.5+2.2 | NSI |
| Urine K+ | 29.3135.0 | 500 | +1.5+0.1 | NSI |
| Urine Cl- | 113.1261.3 | 500 | +2.5+1.8 | NSI |
Results of the lipemia interference testing
| Analyte | Analyteconcentration(mmol/L) | Lipemialevel(mg/dL) | Bias(mmol/L) | Comments |
|---|---|---|---|---|
| BUN | 8.338.2 | 1000 | -1.2-1.1 | NSI |
| Serum Na+ | 125.3147.6 | 1000 | -0.5+0.4 | NSI |
| Serum K+ | 3.085.64 | 1000 | +0.05+0.07 | NSI |
| Serum Cl- | 85.5111.5 | 1000 | +0.0-0.1 | NSI |
| UrineNa+ | 40.9215.8 | 1000 | -0.1-0.8 | NSI |
| Urine K+ | 28.1127.8 | 1000 | +0.1-0.6 | NSI |
| UrineCl- | 110.8232.9 | 1000 | -0.2-0.8 | NSI |
Results of the ascorbic acid interference testing
| Analyte | Analyteconcentration(mmol/L) | Ascorbic Acidlevel(mg/dL) | Bias(mmol/L) | Comments |
|---|---|---|---|---|
| BUN | 9.041.1 | 30 | -0.3-0.4 | NSI |
| Serum Na+ | 132.9153.4 | 30 | -0.3+1.0 | NSI |
| Serum K+ | 3.195.89 | 30 | +0.00+0.01 | NSI |
| Serum Cl- | 89.1114.0 | 30 | -0.2-0.4 | NSI |
Page 12 of 14
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| Urine Na+ | 43.3223.3 | 30 | +0.4+0.8 | NSI |
|---|---|---|---|---|
| Urine K+ | 29.7125.0 | 30 | +0.1-0.1 | NSI |
| Urine Cl- | 116.2251.4 | 30 | +0.0+0.3 | NSI |
There is no significant interference (NSI) observed when the concentrations of interference materials (including drugs) is below the ones in the following table
| Interferents | Level tested(mg/dL) |
|---|---|
| Lipemia | 1000 |
| Bilirubin | 40 |
| Ascorbic Acid | 30 |
| Imipramine | 0.15 |
| Procainamide | 15 |
| Nortriptyline | 0.26 |
| Hydroxytyramine | 50.7 |
| Ibuprofen | 512 |
| Valproic acid | 75 |
| Chlorpromazine | 6 |
| Salicylic acid | 72 |
| Acetylsalicylic acid | 1205 |
| Erythromycin | 7.6 |
| Ethosuximide | 30.6 |
| Acetaminophen | 242 |
| Benzalkonium Chloride | 10.4 |
| Ampicillin | 6 |
There was significant interference for hemoglobin and Potassium Thiocynate.
- · Avoid Hemolyzed samples for potassium. Hemolyzed samples may give incorrect elevated potassium. Intracellular potassium concentration is 30-50 fold greater than that of extracellular serum or plasma.
- · Potassium thiocynate increases potassium by 0.55 mmol/L at the concentration of 3.30 mmol/L and by 0.58 mmol/L at the concentration of 5.39 mmol/L.
- Potassium thiocynate increases chloride by12.3 mmol/L at the concentration of 90.9 mmol/L and by12.6 mmol/L at the concentration of 114.6 mmol/L.
The BS-800M's sample type studies between serum and plasma of Na , K , Cl test yielded the following results, which proved the sample type plasma can also apply to ISE test:
{16}------------------------------------------------
| Analyte | Unit | N | SampleRange | Slope | Intercept | CorrelationCoefficient |
|---|---|---|---|---|---|---|
| Na+ | mmol/L | 51 | 105.2-195.9 | 1.000 | -0.33 | 0.9989 |
| K+ | mmol/L | 51 | 1.45-7.87 | 0.966 | -0.13 | 0.9930 |
| Cl- | mmol/L | 51 | 54.2-148.1 | 0.996 | 0.62 | 0.9997 |
Conclusion:
The data demonstrates that the BS-800M Chemistry Analyzer is substantially equivalent to BS-200 Chemistry Analyzer.
§ 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.