BS-200 CHEMISTRY ANALYZER, MODE BS-200

• K Number: K072018
• Device Name: BS-200 CHEMISTRY ANALYZER, MODE BS-200
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
• Date Cleared: 2008-02-01 ( 193 days)
• Product Code: CFR CEM CGZ JGS JJE
• Regulation Number: 862.1345

Intended Use

The BS-200 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories. The analyzer is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples. 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. 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. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

The BS-200 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K002199 and is the chosen assay to demonstrate performance for the photometric unit. The BS-200 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.

Predicate Devices

K953239, K000926

Reference Devices

K002199

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No.

Explanation: This device is an in vitro diagnostic (IVD) chemistry analyzer designed to quantitatively determine clinical chemistries in various bodily fluids. It provides diagnostic information, but it does not treat or directly improve a patient's health condition, which is characteristic of a therapeutic device.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "The BS-200 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories." It further details its use for the quantitative determination of various clinical chemistries to aid in the diagnosis and treatment of specific diseases and conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "automated clinical chemistry analyzer" and has an "optional Ion-Selective Electrode (ISE) module," indicating it is a hardware device with integrated software, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use Statement: The very first sentence explicitly states: "The BS-200 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories."
• Purpose: The device is designed for the "in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples." This involves testing samples taken from the human body outside of the body, which is the definition of in vitro.
• Specific Analytes: It measures specific analytes (Sodium, Potassium, Chloride, Glucose) in biological samples, and the intended use for these measurements is for the "diagnosis and treatment" of various medical conditions.
• Clinical Laboratory Use: The device is intended for use in "clinical laboratories," which are settings where diagnostic testing is performed.

All of these points clearly indicate that the BS-200 Chemistry Analyzer is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The BS-200 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories. The analyzer is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples.

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.

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.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

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

CFR, JGS, CEM, CGZ, JJE

Device Description

The BS-200 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K002199 and is the chosen assay to demonstrate performance for the photometric unit. The BS-200 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

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

clinical laboratories / clinical laboratory use

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing of the BS-200 Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-200 to evaluate precision, linearity, and method comparison, Limits of Detection and Limits of Quantitation, interference.

A correlation analysis between the BS-200 Chemistry Analyzer and the predicate devices yielded the following results:
GLU (mg/dL): Regression Slope 1.015, Regression Intercept -0.0288, Correlation Coefficient(r) 0.9992, Sample numbers 60
K (mmol/L) serum(ISE): Regression Slope 0.9864, Regression Intercept 0.1226, Correlation Coefficient(r) 0.9980, Sample numbers 40
Na (mmol/L) serum(ISE): Regression Slope 0.9903, Regression Intercept 1.3158, Correlation Coefficient(r) 0.9845, Sample numbers 40
CL (mmol/L) serum(ISE): Regression Slope 0.9815, Regression Intercept 3.4021, Correlation Coefficient(r) 0.9905, Sample numbers 40
K (mmol/L)Urine(ISE): Regression Slope 0.9668, Regression Intercept 0.5307, Correlation Coefficient(r) 0.9991, Sample numbers 40
Na (mmol/L) Urine(ISE): Regression Slope 0.9479, Regression Intercept -3.1284, Correlation Coefficient(r) 0.9977, Sample numbers 40
CL (mmol/L)Urine(ISE): Regression Slope 1.001, Regression Intercept -6.9595, Correlation Coefficient(r) 0.9887, Sample numbers 40

The Within-Run precision test yielded the following results:
Glucose:
Level I: Mean 55.9 mg/dL, SD 0.51 mg/dL, CV 0.9%
Level II: Mean 121.5 mg/dL, SD 0.73 mg/dL, CV 0.6%
Level III: Mean 295.63 mg/dL, SD 1.33 mg/dL, CV 0.5%
ISE Chemistries:
K serum(ISE) Level I Mean Not provided, ST 0.03, CV% 0.7%; Level J' Mean 6.77, SC 0.05, CV% 0.8%
Na serum(ISE) Level I Mean 136.13, ST 0.61, CV% 0.4%; Level J' Mean 146.74, SC 0.72, CV% 0.5%
CL serum(ISE) Level I Mean 99.59, ST 0.73, CV% 0.7%; Level J' Mean 115.68, SC 0.52, CV% 0.5%
K Urine(ISE) Level I Mean 37.09, ST 0.46, CV% 1.2%; Level J' Mean 67.49, SC 0.63, CV% 0.9%
Na Urine(ISE) Level I Mean 99.23, ST 1.13, CV% 1.1%; Level J' Mean 170.84, SC 1.36, CV% 0.8%
CL Urine(ISE) Level I Mean 82.90, ST 1.36, CV% 1.6%; Level J' Mean 132.16, SC 1.24, CV% 0.9%

The Between-run imprecision test yielded the following results:
Glucose:
Level I: Mean 55.9 mg/dL, SD 1.51 mg/dL, CV 2.7%
Level II: Mean 121.5 mg/dL, SD 2.46 mg/dL, CV 2.0%
Level III: Mean 295.63 mg/dL, SD 5.28 mg/dL, CV 1.8%
ISE Chemistries:
K (mmol/L) serum(ISE) Level I Mean 4.11, SD 0.07, CV% 1.6%; Level II Mean 6.77, SD 0.06, CV% 1.0%
Na (mmol/L) serum(ISE) Level I Mean 136.13, SD 2.12, CV% 1.6%; Level II Mean 146.74, SD 1.66, CV% 1.1%
CL (mmol/L) serum(ISE) Level I Mean 99.59, SD 1.78, CV% 1.8%; Level II Mean 115.68, SD 1.13, CV% 1.0%
K (mmol/L)Urine(ISE) Level I Mean 37.09, SD 0.48, CV% 1.3%; Level II Mean 67.49, SD 0.70, CV% 1.0%
Na (mmol/L)Urine(ISE) Level I Mean 99.23, SD 1.68, CV% 1.7%; Level II Mean 170.84, SD 2.41, CV% 1.4%
CL (mmol/L)Urine(ISE) Level I Mean 82.90, SD 1.50, CV% 1.8%; Level II Mean 132.16, SD 2.12, CV% 1.6%

The linearity test yielded the following results:
GLU (mg/dL) Linear range: Lower limit 1, Upper limit 686
K (mmol/L) serum(ISE) Linear range: Lower limit 1.1, Upper limit 8.6
Na (mmol/L) serum(ISE) Linear range: Lower limit 113, Upper limit 194
CL (mmol/L) serum(ISE) Linear range: Lower limit 53, Upper limit 154
K (mmol/L)Urine(ISE) Linear range: Lower limit 13, Upper limit 184
Na (mmol/L) Urine(ISE) Linear range: Lower limit 27, Upper limit 372
CL (mmol/L)Urine(ISE) Linear range: Lower limit 42, Upper limit 422

The Limit of Detection test yielded the following results:
GLU (mg/dl): LoB 0.04, LoD 0.22, LoQ 0.97
K (mmol/L) serum (ISE): LoB 0.1, LoD 0.16, LoQ 0.42
Na (mmol/L) serum(ISE): LoB 1.15, LoD 2.67, LoQ 5.3
CL (mmol/L) serum (ISE): LoB 2.95, LoD 5.0, LoQ 12.0
K (mmol/L)Urine(ISE): LoB 0.26, LoD 0.58, LoQ 1.34
Na (mmol/L) Urine(ISE): LoB 5.85, LoD 8.27, LoQ 22.2
CL (mmol/L)Urine(ISE): LoB 4.5, LoD 6.29, LoQ 17.1

The Interference test yielded the following results:
GLU (mg/dl): Hemoglobin 250mg/dl, Bilirubin 18 mg/dl, Intralipids® 300mg/dl
K (mmol/L) serum(ISE): Hemoglobin >500mg/dl, Bilirubin >20mg/dl, Intralipids® >1000 mg/dl
Na (mmol/L) serum(ISE): Hemoglobin >500mg/dl, Bilirubin >20mg/dl, Intralipids® >1000 mg/dl
CL (mmol/L) serum(ISE): Hemoglobin >500mg/dl, Bilirubin >20mg/dl, Intralipids® >1000 mg/dl

Conclusion: The data demonstrates that the BS-200 Chemistry Analyzer is substantially equivalent to Boehringer Mannheim/Hitachi 917 Analyzer and EasyElectroLyte/RapidLyte Na/K/C1 Analyzer.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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.

K953239, K000926

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.

K002199

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).

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Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Summary

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FEB - 1 2008

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: _ K072018

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: [phone] Fax: [phone]

• Contact Person: ●
  Li Dongling

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: ●

Mar. 5, 2007

Name of the device:

• . Trade/Proprietary Name: BS-200 Chemistry Analyzer
• . Common Name: Clinical Chemistry Analyzer (with optional ISE Module)

Classification Number/Class: ●

75JJE, Class I 75CRF, Class II 75CEM, Class II 75CGE, Class II 75JGS, Class II

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Legally Marketed Predicate Device:

K953239	Boehringer Mannheim/Hitachi 917 Analyzer
K000926	EasyElectroLyte/RapidLyte Na/K/Cl Analyzer
K002199	Liquid Glucose (Hexokinase) Reagent Set

Description:

The BS-200 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K002199 and is the chosen assay to demonstrate performance for the photometric unit. The BS-200 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:

The BS-200 Chemistry Analyzer is an automated chemistry analyzer for in vitro diagnostic use in clinical laboratories. The analyzer is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or cerebral spinal fluid samples.

Indications for Use:

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.

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.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Comparison of Technological Characteristics:

Substantial equivalence has been demonstrated between the BS-200 Chemistry Analyzer and Boehringer Mannheim/Hitachi 917 analyzer. Both of them utilize absorbance photometry to

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perform and output quantitative results for kinetic and endpoint clinical chemistries. For analytes, the BS-200 Chemistry Analyzer and Boehringer Mannheim/Hitachi 917 analyzer determine the concentration of unknown samples from a standard curve generated with known analyte concentrations. Substantial equivalence has also been demonstrated between the BS-200 Chemistry Analyzer and EasyElectroLyte/RapidLyte Na/K/Cl Analyzer. Both of them are used to analyze for electrolytes. The analyzers are calibrated with known concentration callbrator material. The BS-200 Chemistry Analyzer and EasyElectroLyte/RapidLyte Na/K/Cl Analyzer both utilize Ion-Selective Electrodes technology.

Performance Characteristics:

Performance testing of the BS-200 Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-200 to evaluate precision, linearity, and method comparison, Limits of Detection and Limits of Quantitation, interference.

| Item | Regression
Slope | Regression
Intercept | Correlation
Coefficient(r) | Sample
numbers |
|------------------------|---------------------|-------------------------|-------------------------------|-------------------|
| GLU (mg/dL) | 1.015 | -0.0288 | 0.9992 | 60 |
| K (mmol/L) serum(ISE) | 0.9864 | 0.1226 | 0.9980 | 40 |
| Na (mmol/L) serum(ISE) | 0.9903 | 1.3158 | 0.9845 | 40 |
| CL (mmol/L) serum(ISE) | 0.9815 | 3.4021 | 0.9905 | 40 |
| K (mmol/L)Urine(ISE) | 0.9668 | 0.5307 | 0.9991 | 40 |
| Na (mmol/L) Urine(ISE) | 0.9479 | -3.1284 | 0.9977 | 40 |
| CL (mmol/L)Urine(ISE) | 1.001 | -6.9595 | 0.9887 | 40 |

A correlation analysis between the BS-200 Chemistry Analyzer and the predicate devices yielded the following results:

The Within-Run precision test yielded the following results:

Glucose

Level I			Level II			Level III
Mean	SD	CV	Mean	SD	CV	Mean	SD	CV
mg/dL	mg/dL	%	mg/dL	mg/dL	%	mg/dL	mg/dL	%
55.9	0.51	0.9%	121.5	0.73	0.6%	295.63	1.33	0.5%

ISE Chemistries

ltem	Level			Level J'
	Mean	ST	CV%	Mean	SC	CV%
K serum(ISE)
A MOND AND A CONTRACT AND CONSULT OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION OF COLLECTION		0.03	0.7%	6.77	0.05	0.8%

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Na serum(ISE)	136.13	0.61	0.4%	146.74	0.72	0.5%
CL serum(ISE)	99.59	0.73	0.7%	115.68	0.52	0.5%
K Urine(ISE)	37.09	0.46	1.2%	67.49	0.63	0.9%
Na Urine(ISE)	99.23	1.13	1.1%	170.84	1.36	0.8%
CL Urine(ISE)	82.90	1.36	1.6%	132.16	1.24	0.9%

The Between-run imprecision test yielded the following results:

Glucose

Level I			Level II			Level III
Mean	SD	CV	Mean	SD	CV	Mean	SD	CV
mg/dL	mg/dL	%	mg/dL	mg/dL	%	mg/dL	mg/dL	%
55.9	1.51	2.7%	121.5	2.46	2.0%	295.63	5.28	1.8%

ISE Chemistries

Item	Level I			Level II
	Mean	SD	CV%	Mean	SD	CV%
K (mmol/L)
serum(ISE)	4.11	0.07	1.6%	6.77	0.06	1.0%
Na (mmol/L)
serum(ISE)	136.13	2.12	1.6%	146.74	1.66	1.1%
CL (mmol/L)
serum(ISE)	99.59	1.78	1.8%	115.68	1.13	1.0%
K (mmol/L)
Urine(ISE)	37.09	0.48	1.3%	67.49	0.70	1.0%
Na (mmol/L)
Urine(ISE)	99.23	1.68	1.7%	170.84	2.41	1.4%
CL (mmol/L)
Urine(ISE)	82.90	1.50	1.8%	132.16	2.12	1.6%

The linearity test yielded the following results:

	Linear range
Item	Lower limit	Upper limit
GLU (mg/dL)	1	686
K (mmol/L) serum(ISE)	1.1	8.6
Na (mmol/L) serum(ISE)	113	194
CL (mmol/L) serum(ISE)	53	154

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K (mmol/L)Urine(ISE)	13	184
Na (mmol/L) Urine(ISE)	27	372
CL (mmol/L)Urine(ISE)	42	422

The Limit of Detection test yielded the following results:

Item	LoB	LoD	LoQ
GLU (mg/dl)	0.04	0.22	0.97
K (mmol/L) serum (ISE)	0.1	0.16	0.42
Na (mmol/L) serum(ISE)	1.15	2.67	5.3
CL (mmol/L) serum (ISE)	2.95	5.0	12.0
K (mmol/L)Urine(ISE)	0.26	0.58	1.34
Na (mmol/L) Urine(ISE)	5.85	8.27	22.2
CL (mmol/L)Urine(ISE)	4.5	6.29	17.1

The Interference test yielded the following results:

	Interference materials
Item	Hemoglobin	Bilirubin	Intralipids®
GLU (mg/dl)	250mg/dl	18 mg/dl	300mg/dl
K (mmol/L) serum(ISE)	>500mg/dl	>20mg/dl	>1000 mg/dl
Na (mmol/L) serum(ISE)	>500mg/dl	>20mg/dl	>1000 mg/dl
CL (mmol/L) serum(ISE)	>500mg/dl	>20mg/dl	>1000 mg/dl

Conclusion:

The data demonstrates that the BS-200 Chemistry Analyzer is substantially equivalent to Boehringer Mannheim/Hitachi 917 Analyzer and EasyElectroLyte/RapidLyte Na/K/C1 Analyzer.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

FEB - 1 2008

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. c/o Susan D. Goldstein-Falk mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, NY 11021 US

Re: K072018 Trade/Device Name: BS-200 Chemistry Analyzer Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CFR, JGS, CEM, CGZ, JJE Dated: January 25, 2008 Received: January 28, 2008

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K072018 Device Name: Nat, K+, Cl , glucose tests on for BS-200 Analyze Indication For Use:

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.

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.

Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of panereatic islet cell carcinoma.

Prescription Use x (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

s10(k) K072018