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.

Device Description

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.

AI/ML Overview

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.

Summary

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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.

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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)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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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-DevicePrecision
					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%

Page 4 of 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	CorrelationCoefficient	Linear RangeTested	ClaimedLinearRange
BUN	mg/dL	1.0000	-0.0109	0.9992	5.1-165.1	5.5-151.7
SerumNa+	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:

{9}------------------------------------------------

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
BenzalkoniumChloride	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.
Potassiumthiocyanate	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.

Regulation Number and Section

§ 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.