Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard clinical chemistry analyzer using photometric and ion-selective electrode technology, with no mention of AI or ML.

Therapeutic

No
The device is an in vitro diagnostic chemistry analyzer used for quantitative measurements of various substances in biological samples, primarily for diagnosis and monitoring, not for direct therapy.

Diagnostic

Yes

Explanation: The device is designed for making direct quantitative measurements of various substances (Na+, K+, Cl-, Urea Nitrogen) in biological samples (serum, plasma, urine) and is used in clinical chemistry laboratories for the diagnosis and treatment of diseases. This aligns with the definition of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is described as an automated clinical chemistry analyzer, which is a hardware device. It performs photometric assays and has an optional Ion-Selective Electrode (ISE) module, both of which are hardware components.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device 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." It also mentions that the ISE Kit is "for the in vitro quantitative determination of Sodium (Na+), Potassium (K+), and Chloride (Cl-) concentrations in serum, plasma and urine samples." These are all activities performed in vitro (outside the body) on biological samples to provide information for diagnosis or treatment.
Device Description: The description confirms it's an "automated clinical chemistry analyzer capable of performing various in vitro photometric assays."
Purpose of Measurements: The document details how the measurements of Na+, K+, Cl-, and Urea Nitrogen are used "in the diagnosis and treatment of diseases involving electrolyte imbalance," "disease conditions characterized by, low or high blood potassium levels," "electrolyte and metabolic disorders," and "to aid in the determination of liver and kidney function and other diseases associated with protein catabolism." This directly aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for clinical purposes.
Predicate Device: The predicate device listed (K072018 BS-200 Chemistry Analyzer) is also a clinical chemistry analyzer, which are typically classified as IVDs.

Therefore, based on the provided information, the BS-800M/ABS800/BA-800M Chemistry Analyzer and its associated ISE Kit are clearly intended for in vitro diagnostic use.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

JGS, CGZ, CGZ, CEM, CDQ, JJE

Device 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.

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 chemistry laboratory use
Clinical Lab

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-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 (Sample Range, N, Slope, Intercept, Correlation Coefficient):
BUN: 5.4-149.5 mg/dL, 122, 0.98, 0.81, 0.9997
Serum Na+: 100.2-196.4 mmol/L, 124, 1.03, -5.95, 0.9966
Serum K+: 1.40-7.70 mmol/L, 121, 1.04, -0.09, 0.9994
Serum Cl-: 50.4-149.4 mmol/L, 124, 1.00, 0.15, 0.9993
Urine Na+: 12.1-395.4 mmol/L, 120, 0.99, -2.52, 0.9997
Urine K+: 5.1-194.7 mmol/L, 120, 0.98, -1.00, 0.9997
Urine Cl-: 15.2-381.3 mmol/L, 120, 0.97, 2.06, 0.9988

The bias at the medical decision points of method comparison yielded the following results (Point 1, Point 2, Point 3 for Medical decision points and Bias):
BUN: 6 mg/dL (0.696/11.6%), 26 mg/dL (0.317/1.2%), 50 mg/dL (-0.138/-0.3%)
Serum Na+: 115 mmol/L (-2.713/-2.4%), 135 mmol/L (-2.149/-1.6%), 150 mmol/L (-1.727/-1.2%)
Serum K+: 3.0 mmol/L (0.032/1.1%), 5.8 mmol/L (0.144/2.5%), 7.5 mmol/L (0.212/2.8%)
Serum Cl-: 90 mmol/L (0.245/0.3%), 112 mmol/L (0.267/0.2%)
Urine Na+: 40 mmol/L (-2.759/-6.9%), 112 mmol/L (-3.837/-1.7%)
Urine K+: 25 mmol/L (-1.418/-5.7%), 125 mmol/L (-3.085/-2.5%)
Urine Cl-: 110 mmol/L (-1.112/-1.0%), 250 mmol/L (-5.147/-2.1%)

Total precision test of BS-800M (n=80):
BUN: Control pool 1 Mean 11.0, Repeatability SD 0.28, CV% 2.5%, Within-Device Precision SD 0.33, CV% 3.0%; Control pool 2 Mean 46.4, Repeatability SD 0.57, CV% 1.2%, Within-Device Precision SD 0.94, CV% 2.0%
Serum Na+: Control pool 1 Mean 136.1, Repeatability SD 0.35, CV% 0.3%, Within-Device Precision SD 0.83, CV% 0.6%; Control pool 2 Mean 166.1, Repeatability SD 0.46, CV% 0.3%, Within-Device Precision SD 1.12, CV% 0.7%
Serum K+: Control pool 1 Mean 3.72, Repeatability SD 0.006, CV% 0.2%, Within-Device Precision SD 0.021, CV% 0.6%; Control pool 2 Mean 6.10, Repeatability SD 0.013, CV% 0.2%, Within-Device Precision SD 0.033, CV% 0.5%
Serum CL-: Control pool 1 Mean 89.4, Repeatability SD 0.21, CV% 0.2%, Within-Device Precision SD 0.38, CV% 0.4%; Control pool 2 Mean 107.5, Repeatability SD 0.23, CV% 0.2%, Within-Device Precision SD 0.44, CV% 0.4%
Urine Na+: Control pool 1 Mean 87.1, Repeatability SD 0.22, CV% 0.3%, Within-Device Precision SD 0.44, CV% 0.5%; Control pool 2 Mean 148.6, Repeatability SD 0.36, CV% 0.2%, Within-Device Precision SD 0.74, CV% 0.5%
Urine K+: Control pool 1 Mean 35.1, Repeatability SD 0.08, CV% 0.2%, Within-Device Precision SD 0.21, CV% 0.6%; Control pool 2 Mean 68.8, Repeatability SD 0.16, CV% 0.2%, Within-Device Precision SD 0.41, CV% 0.6%
Urine Cl-: Control pool 1 Mean 90.4, Repeatability SD 0.20, CV% 0.2%, Within-Device Precision SD 0.40, CV% 0.4%; Control pool 2 Mean 133.9, Repeatability SD 0.17, CV% 0.1%, Within-Device Precision SD 0.48, CV% 0.4%

Linearity test of BS-800M (Slope, Intercept, Correlation Coefficient, Linear Range Tested, Claimed Linear Range):
BUN: 0.9999, 0.0053, 0.9996, 4.5-162.6, 5-150
Serum Na+: 0.9996, 0.0783, 1.0000, 41.9-224.4, 100-200
Serum K+: 0.9997, -0.0003, 0.9999, 0.61-9.34, 1-8
Serum Cl-: 0.9998, 0.0389, 0.9999, 11.0-162.4, 50-150
Urine Na+: 1.0000, 0.0139, 0.9999, 7.5-469.5, 10-400
Urine K+: 1.0001, 0.0175, 0.9999, 3.1-254.4, 5-200
Urine Cl-: 1.0000, 0.0370, 0.9999, 10.9-439.4, 15-400

Detection limit studies test of BS-800M (LoB, LoD, LoQ):
BUN: 0.4, 0.9, 4.2
Serum Na+: 1.9, 3.5, 39.5
Serum K+: 0.04, 0.05, 0.54
Serum Cl-: 0.5, 0.6, 9.5
Urine Na+: 0.9, 1.4, 6.9
Urine K+: 0.1, 0.2, 2.4
Urine Cl-: 0.2, 0.3, 9.8

Interference test of BS-800M:
No significant interference (NSI) was observed when concentrations of bilirubin, lipemia, and ascorbic acid were within tested levels (Bilirubin 40 mg/dL, Lipemia 1000 mg/dL, Ascorbic Acid 30 mg/dL).
Significant interference was observed for hemoglobin and Potassium Thiocynate for specific analytes.

Avoid hemolyzed samples for potassium, as they may give incorrect elevated results.
Potassium thiocynate increases potassium by 0.55 mmol/L at 3.30 mmol/L and by 0.58 mmol/L at 5.39 mmol/L.
Potassium thiocynate increases chloride by 12.3 mmol/L at 90.9 mmol/L and by 12.6 mmol/L at 114.6 mmol/L.

Sample type studies between serum and plasma for Na, K, Cl tests (N=51):
Na+: Slope 1.000, Intercept -0.33, Correlation Coefficient 0.9989 (Range 105.2-195.9 mmol/L)
K+: Slope 0.966, Intercept -0.13, Correlation Coefficient 0.9930 (Range 1.45-7.87 mmol/L)
Cl-: Slope 0.996, Intercept 0.62, Correlation Coefficient 0.9997 (Range 54.2-148.1 mmol/L)
The study proved that plasma can also apply to ISE test.

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.

K072018, K972671

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

Regulation Number and Section

§ 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.

Summary

0

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

1

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

2

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

4

75CEM, Class II 75CGZ, Class II 75JGS, Class II

Legally Marketed Predicate Device:

K072018

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.

| Comparison
Section | BS-800M | BS-200
(Predicate Device) | |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(K) Number | K160370 | K072018 | |
| Intended 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-200 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
Glucose in serum samples.
Additionally, other various
chemistry assays may be adaptable
to the analyzer depending on the
reagent used to induce a photometric
reaction. | |
| Parameter(photometric) | BUN | BUN | |
| Parameter(ion selective
electrode) | 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 hour
1200 tests per hour with ISE		200 photometric tests per hour
330 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	Endpoint
Fixed-time
Kinetic	Endpoint
Fixed-time
Kinetic	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 positions
respectively for outer two
circles of outer rings and 25
positions respectively for
inter two circles of inter
rings	40 sample tube positions on
the outer circle	D
	Reagent disk	120 positions. 50 positions
for inner circle and 70
positions for outer circle.	40 reagent bottle positions
on the inner circle	D
	Pipttor System	Positive displacement
stepper motordrive	Positive displacement
stepper 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 (Predicate
Device)	Same
(S)/Different
(D)
	510(K)	K160370	K072018	/
1	Indication for use/Intended Use
	ISE Kit	The BS-800M/ ABS800/
BA-800M ISE Module is
for the in vitro quantitative
determination of Sodium	The BS-200 ISE Module is
for the in vitro quantitative
determination of Sodium
(Na⁺), Potassium (K⁺), and	S
		(Na+), Potassium (K+), and
Chloride (Cl-)
concentrations in serum,
plasma and urine samples
on the the BS-800M/
ABS800/
BA-800M
Chemistry Analyzer.	Chloride (Cl-)
concentrations in serum,
plasma and urine samples
on the the BS-200
Chemistry Analyzer.
	Sodium	Sodium measurements
monitor electrolyte balance
and in the diagnosis and
treatment of diseases
involving electrolyte
imbalance.	Sodium measurements
monitor electrolyte balance
and in the diagnosis and
treatment of diseases
involving electrolyte
imbalance.	S
	Potassium	Potassium measurements
monitor electrolyte balance
and in the diagnosis and
treatment of disease
conditions characterized by,
low or high blood potassium
levels.	Potassium measurements
monitor electrolyte balance
and in the diagnosis and
treatment of disease
conditions characterized by,
low or high blood potassium
levels.	S
	Chloride	Chloride measurements are
used in the diagnosis and
treatment of electrolyte and
metabolic disorders.	Chloride measurements are
used in the diagnosis and
treatment of electrolyte and
metabolic 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, Space
electrode	D
	Reference reagent	MR Serum Standard, MR
Urine Standard, MR Buffer
Solution, MR Detergent
Solution, MR Na/K Check
Solution	Reagent Pack, Urine
Diluent, Cleaning Solution,	D
	ISE Internal
Standard	None	None	S
	Sample Volume	22 µL total for all three tests	70 µL Serum, plasma mode;
140 µL Urine mode	D
	ISE Throughput
Rate	600 tests/hour	300 tests/hour Serum,
plasma mode;	D
	Test Environment	198 tests/hour Urine mode
Clinical Lab		S
3	Calibration
	Calibrator	MR Serum Standard for
Serum, Plasma mode;
MR Urine standard for
Urine mode;	ISE reagent pack for all
three sample types	D
	Standardization	Na: NIST standard material
SRM919
K: NIST standard material
SRM 918
Cl: NIST standard material
SRM 919	Na: NIST standard material
SRM956
K: NIST standard material
SRM 956
Cl: NIST standard material
SRM 956	D
	Calibrator Stability	5°C~35°C, 12 months of
shelf-life, 8 weeks of in-use
stability	4°C~25°C, 24 months of
shelf-life	D
	Calibrator Matrix	Buffered Aqueous matrix	Buffered Aqueous matrix	S
	Calibrator Form	liquid	liquid	S
	Number of
Calibrator levels	Two for serum/Plasma and
Two for Urine	Two for serum/plasma/urine	S
	Calibration
Frequency	Daily	8 hours	D
4	Performance Characters
	Analytical
Measuring
(mmol/L)	Serum/Plasma
Na: 100-200
K: 1-8
Cl: 50-150

Urine
Na: 10-400
K: 5-200
Cl: 15-400 | Serum/Plasma
Na: 113-194
K: 1.1-8.6
Cl: 53-154

Urine
Na: 27-372
K: 13-184
Cl: 42-422 | D | |
| | Reference Interval | Serum(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.5-5.1 mmol/L
Chloride: 98-107 mmol/L
Plasma(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.4-4.5 mmol/L
Chloride: 98-107 mmol/L
Urine. 24 hour (Adults): | Serum(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.5-5.1 mmol/L
Chloride: 98-107 mmol/L
Plasma(Adults):
Sodium: 136-145 mmol/L
Potassium: 3.4-4.5 mmol/L
Chloride: 98-107 mmol/L
Urine. 24 hour (Adults): | S | |

7

8

9

10

	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 Interferences
concentration	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 | Sample
Range | N | Slope | Intercept | Correlation
Coefficient |
|-----------|--------|-----------------|-----|-------|-----------|----------------------------|
| 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

11

| 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-Device
Precision | |
|-----------|--------|-------------------|----|-------|---------------|------|----------------------------|------|
| | | | | | SD | CV% | SD | CV% |
| BUN | mg/dL | Control
pool 1 | 80 | 11.0 | 0.28 | 2.5% | 0.33 | 3.0% |
| | mg/dL | Control
pool 2 | 80 | 46.4 | 0.57 | 1.2% | 0.94 | 2.0% |
| Serum Na+ | mmol/L | Control
pool 1 | 80 | 136.1 | 0.35 | 0.3% | 0.83 | 0.6% |
| | mmol/L | Control
pool 2 | 80 | 166.1 | 0.46 | 0.3% | 1.12 | 0.7% |
| Serum K+ | mmol/L | Control
pool 1 | 80 | 3.72 | 0.006 | 0.2% | 0.021 | 0.6% |
| | mmol/L | Control
pool 2 | 80 | 6.10 | 0.013 | 0.2% | 0.033 | 0.5% |
| Serum CL- | mmol/L | Control
pool 1 | 80 | 89.4 | 0.21 | 0.2% | 0.38 | 0.4% |
| | mmol/L | Control
pool 2 | 80 | 107.5 | 0.23 | 0.2% | 0.44 | 0.4% |

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12

		pool 2
Urine Na+	mmol/L	Control
pool 1	80	87.1	0.22	0.3%	0.44	0.5%
Urine Na+	mmol/L	Control
pool 2	80	148.6	0.36	0.2%	0.74	0.5%
Urine K+	mmol/L	Control
pool 1	80	35.1	0.08	0.2%	0.21	0.6%
Urine K+	mmol/L	Control
pool 2	80	68.8	0.16	0.2%	0.41	0.6%
Urine Cl-	mmol/L	Control
pool 1	80	90.4	0.20	0.2%	0.40	0.4%
Urine Cl-	mmol/L	Control
pool 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 | Correlation
Coefficient | Linear Range
Tested | Claimed
Linear
Range |
|--------------|--------|--------|-----------|----------------------------|------------------------|----------------------------|
| BUN | mg/dL | 0.9999 | 0.0053 | 0.9996 | 4.5-162.6 | 5-150 |
| Serum
Na+ | mmol/L | 0.9996 | 0.0783 | 1.0000 | 41.9-224.4 | 100-200 |
| Serum
K+ | mmol/L | 0.9997 | -0.0003 | 0.9999 | 0.61-9.34 | 1-8 |
| Serum
Cl- | mmol/L | 0.9998 | 0.0389 | 0.9999 | 11.0-162.4 | 50-150 |
| Urine
Na+ | 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 |
| Urine
Cl- | 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

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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 | Analyte
concentration
(mmol/L) | Bilirubin
level(mg/dL) | Bias(mmol/L) | Comments |
|-----------|--------------------------------------|---------------------------|----------------|----------|
| BUN | 8.5
39.5 | 40 | +0.0
-0.1 | NSI |
| Serum Na+ | 134.0
154.8 | 40 | -0.4
+0.4 | NSI |
| Serum K+ | 3.23
5.94 | 40 | -0.01
+0.00 | NSI |
| Serum Cl- | 89.7
114.7 | 40 | -0.1
-0.2 | NSI |
| Urine Na+ | 45.9
224.1 | 40 | +0.6
-1.3 | NSI |
| Urine K+ | 26.9
127.3 | 40 | +0.0
-0.4 | NSI |
| Urine Cl- | 113.9
253.5 | 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	8.6
40.0	500	+0.4
-0.1	NSI
Serum Na+	129.4
153.1	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

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| Serum Cl- | 88.8
113.5 | 500 | +2.0
+2.6 | NSI |
|-----------|----------------|-----|--------------|-----|
| Urine Na+ | 45.1
223.4 | 500 | +1.5
+2.2 | NSI |
| Urine K+ | 29.3
135.0 | 500 | +1.5
+0.1 | NSI |
| Urine Cl- | 113.1
261.3 | 500 | +2.5
+1.8 | NSI |

Results of the lipemia interference testing

| Analyte | Analyte
concentration
(mmol/L) | Lipemia
level(mg/dL) | Bias(mmol/L) | Comments |
|-----------|--------------------------------------|-------------------------|----------------|----------|
| BUN | 8.3
38.2 | 1000 | -1.2
-1.1 | NSI |
| Serum Na+ | 125.3
147.6 | 1000 | -0.5
+0.4 | NSI |
| Serum K+ | 3.08
5.64 | 1000 | +0.05
+0.07 | NSI |
| Serum Cl- | 85.5
111.5 | 1000 | +0.0
-0.1 | NSI |
| UrineNa+ | 40.9
215.8 | 1000 | -0.1
-0.8 | NSI |
| Urine K+ | 28.1
127.8 | 1000 | +0.1
-0.6 | NSI |
| UrineCl- | 110.8
232.9 | 1000 | -0.2
-0.8 | NSI |

Results of the ascorbic acid interference testing

| Analyte | Analyte
concentration
(mmol/L) | Ascorbic Acid
level(mg/dL) | Bias(mmol/L) | Comments |
|-----------|--------------------------------------|-------------------------------|----------------|----------|
| BUN | 9.0
41.1 | 30 | -0.3
-0.4 | NSI |
| Serum Na+ | 132.9
153.4 | 30 | -0.3
+1.0 | NSI |
| Serum K+ | 3.19
5.89 | 30 | +0.00
+0.01 | NSI |
| Serum Cl- | 89.1
114.0 | 30 | -0.2
-0.4 | NSI |

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| Urine Na+ | 43.3
223.3 | 30 | +0.4
+0.8 | NSI |
|-----------|----------------|----|--------------|-----|
| Urine K+ | 29.7
125.0 | 30 | +0.1
-0.1 | NSI |
| Urine Cl- | 116.2
251.4 | 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 | Sample
Range | Slope | Intercept | Correlation
Coefficient |
|---------|--------|----|-----------------|-------|-----------|----------------------------|
| 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.