(167 days)
Not Found
No
The summary describes a standard automated clinical chemistry analyzer using photometric and ion-selective electrode technology. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
Explanation: This device is a chemistry analyzer used for diagnostic purposes by measuring various substances in body fluids; it does not directly treat or alleviate a disease or condition.
Yes
The device is designed for clinical laboratory use to make quantitative measurements of various analytes (Na+, K+, Cl-, Urea Nitrogen) in biological samples, and these measurements are explicitly stated to be "used in the diagnosis and treatment of diseases" and to "aid in the determination of liver and kidney functions and other diseases." This aligns with the definition of a diagnostic device.
No
The device description clearly states it is an "automated clinical chemistry analyzer" and mentions an optional "Ion-Selective Electrode (ISE) module," indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device 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." This describes testing performed on samples taken from the human body to provide information for diagnosis or treatment.
- Device Description: The device is described as an "automated clinical chemistry analyzer capable of performing various in vitro photometric assays." "In vitro" means "in glass" or "in the lab," referring to tests performed outside of the living organism.
- Performance Studies: The performance studies involve testing the device with samples (serum, plasma, urine) and comparing the results to a predicate device, which is typical for IVD submissions.
- Predicate Device: The predicate device listed (BS-400 Chemistry Analyzer) is also a clinical chemistry analyzer, which are generally classified as IVDs.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BS-480/BS-490/CLC720i 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.
Product codes (comma separated list FDA assigned to the subject device)
CDO, JGS, CEM, CGZ, JJE
Device Description
The BS-480/BS-490/CLC720i 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the BS-480 Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-480 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-480 Chemistry Analyzer and BS-400 Chemistry Analyzer yielded the following results:
BUN: Unit mg/dL, Sample Range 5.7-147.4, N 120, Slope 0.9912, Intercept 0.0494, Correlation Coefficient 1.000
Serum Na+: Unit mmol/L, Sample Range 101.3-197.1, N 132, Slope 0.9613, Intercept 3.243, Correlation Coefficient 0.998
Serum K†: Unit mmol/L, Sample Range 1.35-7.34, N 120, Slope 0.9570, Intercept 0.0914, Correlation Coefficient 1.000
Serum Cl: Unit mmol/L, Sample Range 54.7-147, N 125, Slope 0.9537, Intercept 4.216, Correlation Coefficient 0.998
Urine Na*: Unit mmol/L, Sample Range 12-473, N 120, Slope 0.9925, Intercept -0.9291, Correlation Coefficient 1.000
Urine K+:mmol/L, Sample Range 5-192, N 120, Slope 0.9677, Intercept 0.6774, Correlation Coefficient 1.000
Urine Cli: Unit mmol/L, Sample Range 16-396, N 120, Slope 1.006, Intercept 2.704, Correlation Coefficient 1.000
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the symbol.
Public Health Service
September 2, 2014
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. C/O SUSAN GOLDSTEIN-FALK MDI CONSULTANTS, INC. 55 NORTHERN BLVD., SUITE 200 GREAT NECK, NY 11021
Re: K140690 Trade/Device Name: BS-480/BS490/CLC720i Chemistry Analyzer Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: II Product Code: CDO. JGS. CEM. CGZ. JJE Dated: July 25, 2014 Received: July 28, 2014
Dear Ms. Susan Goldstein-Falk:
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 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.
1
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/Resourcesfor You/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) K140690
Device Name BS-480/BS-490/CLC720i Chemistry Analyzer
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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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: K140690
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:
Tan Chuanbin
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:
February 20, 2014
Name of the device:
-
Trade/Proprietary Name: BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720i Chemistry Analyzer (BS-480, BS-490 and CLC720i are the same analyzers except the Models. For convenience of explanation, the BS-480 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 75CEM, Class II
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75CGZ, Class II 75JGS, Class II
Legally Marketed Predicate Device:
K112377 BS-400 Chemistry Analyzer, Mindray K971309 UREA, DERMA MEDIA LAB., INC.
Description:
The BS-480/BS-490/CLC720i 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.
Intended Use/ Indication for Use:
The BS-480/BS-490/CLC720i chemistry analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na (sodium), 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.
Comparison of Technological Characteristics:
Substantial equivalence has been demonstrated between the BS-480 Chemistry Analyzer and BS-400 Chemistry Analyzer. Both of them utilize absorbance photometry to perform and output quantitative results for kinetic and endpoint clinical chemistries. For analytes, BS-480 Chemistry Analyzer and BS-400 Chemistry Analyzer determine the concentration of unknown samples from a standard curve generated with known analyte concentrations. The BS-480 Chemistry Analyzer and BS-400 Chemistry Analyzer both utilize Ion-Selective Electrodes technology and are equipped with the same ISE Module.
Performance Characteristics:
5
Performance testing of the BS-480 Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-480 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-480 Chemistry Analyzer and BS-400 Chemistry Analyzer yielded the following results:
| Analyte | Unit | Sample Range | N | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|---|---|---|
| BUN | mg/dL | 5.7-147.4 | 120 | 0.9912 | 0.0494 | 1.000 |
| Serum Na+ | mmol/L | 101.3-197.1 | 132 | 0.9613 | 3.243 | 0.998 |
| Serum K† | mmol/L | 1.35-7.34 | 120 | 0.9570 | 0.0914 | 1.000 |
| Serum Cl | mmol/L | 54.7-147 | 125 | 0.9537 | 4.216 | 0.998 |
| Urine Na* | mmol/L | 12-473 | 120 | 0.9925 | -0.9291 | 1.000 |
| Urine K+ | mmol/L | 5-192 | 120 | 0.9677 | 0.6774 | 1.000 |
| Urine Cli | mmol/L | 16-396 | 120 | 1.006 | 2.704 | 1.000 |
And the bias at the medical decision points of method comparison yielded the following results:
| 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 | 0.00/-0.1% | -0.18/-0.7% | -0.39/-0.8% |
| Serum Na+ | mmol/L | 115,135,150 | -1.26/-1.1% | -2.0/-1.5% | -2.55/-1.7% |
| Serum K+ | mmol/L | 3.0, 5.8, 7.5 | -0.038/-1.3% | -0.158/-2.7% | -2.31/-3.1% |
| Serum Cl- | mmol/L | 90,112 | 0.05/0.1% | -0.97/-0.9% | / |
| Urine Na+ | mmol/L | 40,112 | -1.2/-3.1% | -2.6/-1.2% | / |
| Urine K+ | mmol/L | 25,125 | -0.1/-0.5% | -3.4/-2.7% | / |
| Urine Cl- | mmol/L | 110,250 | 3.4/3.1% | 4.2/1.7% | / |
The preliminary precision test of BS-480 yielded the following results:
| Analyte | Unit | Level | Mean | SD | CV% |
|---|---|---|---|---|---|
| BUN | mg/dL | Control pool 1 | 16.1 | 0.13 | 0.8% |
| Control pool 2 | 41.6 | 0.41 | 1.0% | ||
| Control pool 3 | 66.5 | 0.33 | 0.5% | ||
| Patient pool 1 | 8.8 | 0.09 | 1.0% |
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| Patient pool 2 | 20.4 | 0.09 | 0.4% | ||
|---|---|---|---|---|---|
| Patient pool 3 | 41.3 | 0.16 | 0.4% | ||
| Control pool 1 | 140.5 | 0.35 | 0.3% | ||
| Control pool 2 | 158.0 | 0.27 | 0.2% | ||
| Control pool 3 | 117.0 | 0.28 | 0.2% | ||
| Serum Na+ | mmol/L | Patient pool 1 | 114.6 | 0.37 | 0.3% |
| Patient pool 2 | 128.0 | 0.42 | 0.3% | ||
| Patient pool 3 | 154.1 | 0.87 | 0.6% | ||
| Control pool 1 | 3.69 | 0.010 | 0.3% | ||
| Control pool 2 | 5.58 | 0.015 | 0.3% | ||
| Control pool 3 | 2.79 | 0.010 | 0.4% | ||
| Serum K+ | mmol/L | Patient pool 1 | 2.93 | 0.007 | 0.2% |
| Patient pool 2 | 5.45 | 0.021 | 0.4% | ||
| Patient pool 3 | 7.19 | 0.032 | 0.4% | ||
| Control pool 1 | 103.1 | 0.37 | 0.4% | ||
| mmol/L | Control pool 2 | 124.7 | 0.28 | 0.2% | |
| Serum Cl- | Control pool 3 | 83.0 | 0.26 | 0.3% | |
| Patient pool 1 | 88.6 | 0.30 | 0.3% | ||
| Patient pool 2 | 117.0 | 0.69 | 0.6% | ||
| Control pool 1 | 74 | 0.9 | 1.3% | ||
| Control pool 2 | 165 | 2.4 | 1.4% | ||
| Urine Na+ | mmol/L | Patient pool 1 | 41 | 0.3 | 0.8% |
| Patient pool 2 | 203 | 0.5 | 0.2% | ||
| Control pool 1 | 34 | 0.4 | 1.3% | ||
| Control pool 2 | 96 | 0.4 | 0.5% | ||
| Urine K+ | mmol/L | Patient pool 1 | 26 | 0.0 | 0.0% |
| Patient pool 2 | 119 | 0.5 | 0.4% | ||
| Control pool 1 | 71 | 1.1 | 1.5% | ||
| Control pool 2 | 199 | 1.5 | 0.7% | ||
| Urine Cl- | mmol/L | Patient pool 1 | 113 | 1.1 | 0.9% |
| Patient pool 2 | 246 | 0.9 | 0.4% |
The total precision test of BS-480 yielded the following results:
| Analyte | Unit | Sample | n | Mean | Repeatability | | Within-Device
Precision | |
|---------|-------|----------------|----|------|---------------|------|----------------------------|------|
| | | | | | SD | CV% | SD | CV% |
| BUN | mg/dL | Control pool 1 | 80 | 16.0 | 0.12 | 0.7% | 0.28 | 1.7% |
| | | Control pool 2 | 80 | 41.3 | 0.18 | 0.4% | 0.70 | 1.7% |
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| Control pool 3 | 80 | 66.4 | 0.30 | 0.5% | 1.18 | 1.8% | ||
|---|---|---|---|---|---|---|---|---|
| Control pool 1 | 80 | 142.2 | 0.51 | 0.4% | 1.15 | 0.8% | ||
| Serum | ||||||||
| $Na^+$ | mmol/L | Control pool 2 | 80 | 159.9 | 0.35 | 0.2% | 1.02 | 0.6% |
| Control pool 3 | 80 | 118.5 | 0.25 | 0.2% | 0.81 | 0.7% | ||
| Control pool 1 | 80 | 3.70 | 0.01 | 0.4% | 0.03 | 0.9% | ||
| Serum | ||||||||
| $K^+$ | mmol/L | Control pool 2 | 80 | 5.64 | 0.02 | 0.3% | 0.04 | 0.7% |
| Control pool 3 | 80 | 2.78 | 0.01 | 0.4% | 0.02 | 0.8% | ||
| Control pool 1 | 80 | 102.6 | 0.53 | 0.5% | 0.93 | 0.9% | ||
| Serum | ||||||||
| $Cl^-$ | mmol/L | Control pool 2 | 80 | 125.0 | 0.43 | 0.3% | 0.86 | 0.7% |
| Control pool 3 | 80 | 82.3 | 0.40 | 0.5% | 0.67 | 0.8% | ||
| Urine | ||||||||
| $Na^+$ | mmol/L | Control pool 1 | 80 | 75 | 1.29 | 1.7% | 2.21 | 2.9% |
| Control pool 2 | 80 | 165 | 1.75 | 1.1% | 2.93 | 1.8% | ||
| Urine | ||||||||
| $K^+$ | mmol/L | Control pool 1 | 80 | 34 | 0.16 | 0.5% | 0.49 | 1.5% |
| Control pool 2 | 80 | 97 | 0.34 | 0.3% | 0.77 | 0.8% | ||
| Urine | ||||||||
| $Cl^-$ | mmol/L | Control pool 1 | 80 | 76 | 0.89 | 1.2% | 2.02 | 2.7% |
| Control pool 2 | 80 | 202 | 1.20 | 0.6% | 2.32 | 1.1% |
The linearity test of BS-480 yielded the following results:
| Analyte | Unit | Slope | Intercept | Correlation
Coefficient | Linear Range
Tested | Claimed
Linear
Range |
|--------------|--------|--------|-----------|----------------------------|------------------------|----------------------------|
| BUN | mg/dL | 1.0000 | -0.0109 | 0.9992 | 5.1-165.1 | 5.5-151.7 |
| Serum
Na+ | mmol/L | 1.0001 | -0.0073 | 0.9999 | 69.1-250.2 | 100-200 |
| Serum K+ | mmol/L | 1.0001 | -0.0005 | 0.9998 | 0.85-9.76 | 1-8 |
| Serum Cl- | mmol/L | 0.9999 | -0.0126 | 0.9999 | 44.7-186.1 | 50-150 |
| Urine Na+ | mmol/L | 1.0001 | -0.0461 | 1.0000 | 10-614 | 10-500 |
| Urine K+ | mmol/L | 1.0005 | -0.2565 | 0.9997 | 4-230 | 5-200 |
| Urine Cl- | mmol/L | 1.0000 | -0.2015 | 0.9996 | 7-452 | 15-400 |
The detection limit studies test of BS-480 yielded the following results:
| Analyte | Unit | LoB | LoD | LoQ |
|---|---|---|---|---|
| BUN | mg/dL | 0.2 | 0.3 | 4.8 |
| Serum Na+ | mmol/L | 3.7 | 5.1 | 48.0 |
| Serum K+ | mmol/L | 0.21 | 0.24 | 0.69 |
| Serum Cl | mmol/L | 1.2 | 3.7 | 36.6 |
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| Urine Na+ | mmol/L | 3 | 4.5 | 10 |
|---|---|---|---|---|
| Urine K+ | mmol/L | 1 | 1.2 | 3.3 |
| Urine Cl- | mmol/L | 1 | 2.6 | 6.3 |
The Interference test of BS-480 yielded the following results:
Effects of bilirubin, hemoglobin, lipemia, ascorbic acid are tested. There is no significant interference (NSI) observed when the concentrations of interference materials is below the ones in the following table
| Interference materials (mg/dL) | ||||
|---|---|---|---|---|
| Item | Bilirubin | Hemoglobin | Lipemia | ascorbic acid |
| BUN | 40 | 500 | 1000 | 30 |
| Serum Na+ | 40 | 500 | 1000 | 30 |
| Serum K+ | 40 | / | 1000 | 30 |
| Serum Cl- | 40 | 500 | 1000 | 30 |
| Urine Na+ | 40 | 500 | 1000 | 30 |
| Urine K+ | 40 | 125 | 1000 | 30 |
| Urine Cl- | 40 | 250 | 1000 | 30 |
- For Potassium, hemolysis can lead to falsely elevated K values, so there is no claimed NSI concentration of hemoglobin to Serum K*.
The Interference test of BS-480 yielded the following results:
There was no significant interference for these drugs, when these and interferents were tested in the concentration ranges indicated below:
| Drug interferents | Drug level tested(mg/dL) |
|---|---|
| Imipramine | 0.15 |
| Procainamide | 15 |
| Nortriptyline | 0.23 |
| Hydroxytyramine | 50.4 |
| Valproic acid | 75.5 |
| Chlorpromazine | 6 |
| Salicylic acid | 70.5 |
| Acetylsalicylic acid | 1201 |
| Erythromycin | 7.1 |
| Ethosuximide | 30.5 |
| Acetaminophen | 242 |
| Ampicillin | 6 |
There was significant interference for Ibuprofen, Benzalkonium Chloride and Potassium thiocynate, when these analytes and interferents were tested in the concentration ranges indicated below:
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| Drug interferents | ISE application | Drug level tested(mg/dL) | Effect |
|---|---|---|---|
| Ibuprofen | Serum K+ | 506 | Decreases Potassium by 0.5mmol/L at the concentration of 3.25 mmol/L and by 0.59 mmol/L at the concentration of 5.39 mmol/L; |
| Serum Cl- | 380 | Increases Chloride by 15.4 mmol/L at the concentration of 99 mmol/L and by14.6 mmol/L at the concentration of 119.3 mmol/L | |
| Benzalkonium | |||
| Chloride | Serum Na+ | 7.7 | Increases Sodium by 21.5 mmol/L at the concentration of 130.5 mmol/L and by 17.4 mmol/L at the concentration of 146.1 mmol/L; |
| Serum K+ | 5.2 | Increases Potassium by 0.38 mmol/L at the concentration of 2.97 mmol/L. | |
| Potassium | |||
| thiocyanate | Serum K+ | 6.1 | Increases Potassium by 0.71 mmol/L at the concentration of 2.97 mmol/L and by 0.65 mmol/L at the concentration of 5.08 mmol/L; |
| Serum Cl- | 12.2 | Increases Chloride by 13.4 mmol/L at the concentration of 90.1 mmol/L and by14.4 mmol/L at the concentration of 111.2 mmol/L. |
The BS-480's sample type studies between serum and plasma of Na", K*, CI test yielded the following results, which proved the sample type plasma can also apply to ISE test:
| Analyte | Unit | N | Sample Range | Slope | Intercept | Correlation Coefficient |
|---|---|---|---|---|---|---|
| Na+ | mmol/L | 67 | 103.2-185.5 | 0.971 | 2.9 | 0.995 |
| K+ | mmol/L | 67 | 1.2-6.9 | 0.974 | -0.17 | 0.992 |
| Cl- | mmol/L | 67 | 70.4-143.2 | 1.005 | -0.1 | 0.995 |
Conclusion:
The data demonstrates that the BS-480 Chemistry Analyzer is substantially equivalent to BS-400 Chemistry Analyzer.