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.

AI/ML Overview

The provided text describes the performance characteristics of the BS-200 Chemistry Analyzer through various tests, including precision, linearity, method comparison, limits of detection, and interference. However, it does not explicitly state predetermined "acceptance criteria" for these performance metrics. Instead, it presents the reported performance values without defining specific thresholds for approval. The study aims to demonstrate substantial equivalence to predicate devices.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" are not provided in the text. The table below lists the reported performance data. The implicit acceptance criterion is that these reported performances demonstrate "substantial equivalence" to the predicate devices.

| Performance Metric | Analytes/Levels |---------------------------|------------------------------- | Method Comparison (Correlation with Predicate | | K (mmol/L) serum(ISE) | | Na (mmol/L) serum(ISE) | | CL (mmol/L) serum(ISE) | | K (mmol/L)Urine(ISE) | | Na (mmol/L) Urine(ISE) | | CL (mmol/L)Urine(ISE) | Within-Run Precision (CV%) | Glucose | | Glucose (Level II: 121.5 mg/dL) | | Glucose (Level III: 295.63 mg/dL) | | K serum(ISE) (Level I: Mean ≈ 3.7) | | K serum(ISE) (Level II: Mean ≈ 6.77) | | Na serum(ISE) (Level I: 136.13) | | Na serum(ISE) (Level II: 146.74) | | CL serum(ISE) (Level I: 99.59) | | CL serum(ISE) (Level II: 115.68) | | K Urine(ISE) (Level I: 37.09) | | K Urine(ISE) (Level II: 67.49) | | Na Urine(ISE) (Level I: 99.23) | | Na Urine(ISE) (Level II: 170.84) | | CL Urine(ISE) (Level I: 82.90) | | CL Urine(ISE) (Level II: 132.16) | Between-Run Precision (CV%) | Glucose | | Glucose (Level II: 121.5 mg/dL) | | Glucose (Level III: 295.63 mg/dL) | | K serum(ISE) (Level I: 4.11 mmol/L) | | K serum(ISE) (Level II: 6.77 mmol/L) | | Na serum(ISE) (Level I: 136.13 mmol/L) | | Na serum(ISE) (Level II: 146.74 mmol/L) | | CL serum(ISE) (Level I: 99.59 mmol/L) | | CL serum(ISE) (Level II: 115.68 mmol/L) | | K Urine(ISE) (Level I: 37.09 mmol/L) | | K Urine(ISE) (Level II: 67.49 mmol/L) | | Na Urine(ISE) (Level I: 99.23 mmol/L) | | Na Urine(ISE) (Level II: 170.84 mmol/L) | | CL Urine(ISE) (Level I: 82.90 mmol/L) | | CL Urine(ISE) (Level II: 132.16 mmol/L) | Linearity Range | GLU (mg/dL) | | K (mmol/L) serum(ISE) | | Na (mmol/L) serum(ISE) | | CL (mmol/L) serum(ISE) | | K (mmol/L)Urine(ISE) | | Na (mmol/L) Urine(ISE) | | CL (mmol/L)Urine(ISE) | Limit of Detection | GLU (mg/dl) | | K (mmol/L) serum (ISE) | | Na (mmol/L) serum(ISE) | | CL (mmol/L) serum (ISE) | | K (mmol/L)Urine(ISE) | | Na (mmol/L) Urine(ISE) | | CL (mmol/L)Urine(ISE) | Interference | GLU (mg/dl) | | K (mmol/L) serum(ISE) | | Na (mmol/L) serum(ISE) | | CL (mmol/L) serum(ISE) | Reported Device Performance |
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Device) | GLU (mg/dL) | Slope: 1.015, Intercept: -0.0288, Correlation Coefficient (r): 0.9992 |
| Slope: 0.9864, Intercept: 0.1226, Correlation Coefficient (r): 0.9980 |
| Slope: 0.9903, Intercept: 1.3158, Correlation Coefficient (r): 0.9845 |
| Slope: 0.9815, Intercept: 3.4021, Correlation Coefficient (r): 0.9905 |
| Slope: 0.9668, Intercept: 0.5307, Correlation Coefficient (r): 0.9991 |
| Slope: 0.9479, Intercept: -3.1284, Correlation Coefficient (r): 0.9977 |
| Slope: 1.001, Intercept: -6.9595, Correlation Coefficient (r): 0.9887 |
(Level I: 55.9 mg/dL) | 0.9% |
| 0.6% |
| 0.5% |
| 0.7% |
| 0.8% |
| 0.4% |
| 0.5% |
| 0.7% |
| 0.5% |
| 1.2% |
| 0.9% |
| 1.1% |
| 0.8% |
| 1.6% |
| 0.9% |
(Level I: 55.9 mg/dL) | 2.7% |
| 2.0% |
| 1.8% |
| 1.6% |
| 1.0% |
| 1.6% |
| 1.1% |
| 1.8% |
| 1.0% |
| 1.3% |
| 1.0% |
| 1.7% |
| 1.4% |
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 1.8% |
-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 1.6% |
-----------------------------------------------------------------------------| Lower limit: 1, Upper limit: 686 |
-----------------------------------------------------------------------------| Lower limit: 1.1, Upper limit: 8.6 |
-----------------------------------------------------------------------------| Lower limit: 113, Upper limit: 194 |
-----------------------------------------------------------------------------| Lower limit: 53, Upper limit: 154 |
-----------------------------------------------------------------------------| Lower limit: 13, Upper limit: 184 |
-----------------------------------------------------------------------------| Lower limit: 27, Upper limit: 372 |
-----------------------------------------------------------------------------| Lower limit: 42, Upper limit: 422 |
-----------------------------------------------------------------------------| LoB: 0.04, LoD: 0.22, LoQ: 0.97 |
-----------------------------------------------------------------------------| LoB: 0.1, LoD: 0.16, LoQ: 0.42 |
-----------------------------------------------------------------------------| LoB: 1.15, LoD: 2.67, LoQ: 5.3 |
-----------------------------------------------------------------------------| LoB: 2.95, LoD: 5.0, LoQ: 12.0 |
-----------------------------------------------------------------------------| LoB: 0.26, LoD: 0.58, LoQ: 1.34 |
-----------------------------------------------------------------------------| LoB: 5.85, LoD: 8.27, LoQ: 22.2 |
-----------------------------------------------------------------------------| LoB: 4.5, LoD: 6.29, LoQ: 17.1 |
-----------------------------------------------------------------------------| Hemoglobin: 250mg/dl, Bilirubin: 18 mg/dl, Intralipids®: 300mg/dl (no interference at these levels) |
-----------------------------------------------------------------------------| Hemoglobin: >500mg/dl, Bilirubin: >20mg/dl, Intralipids®: >1000 mg/dl (no interference at these levels) |
-----------------------------------------------------------------------------| Hemoglobin: >500mg/dl, Bilirubin: >20mg/dl, Intralipids®: >1000 mg/dl (no interference at these levels) |
-----------------------------------------------------------------------------| Hemoglobin: >500mg/dl, Bilirubin: >20mg/dl, Intralipids®: >1000 mg/dl (no interference at these levels) |

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Sizes:
- Method Comparison: 60 samples for Glucose, 40 samples for K, Na, and Cl in serum, and 40 samples for K, Na, and Cl in urine.
- Precision (Within-Run & Between-Run): Three levels tested for Glucose and two levels for ISE chemistries. The exact number of replicates per level is not specified, but typically precision studies involve multiple replicates over several days.
- Linearity, Limit of Detection, Interference: Sample sizes for these tests are not explicitly stated.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this type of device and study. This is a clinical chemistry analyzer, and the "ground truth" for its performance is typically established by reference methods or validated predicate devices, not by human expert interpretation for subjective analysis.

4. Adjudication Method for the Test Set

This is not applicable. The data presented are quantitative measurements from a chemistry analyzer, not qualitative assessments requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This is not applicable. An MRMC study involves human readers interpreting cases/images, often with and without AI assistance, to assess the impact of AI on reader performance. This study is for a clinical chemistry analyzer, which provides automated quantitative results, not interpretations by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation. The BS-200 Chemistry Analyzer is an automated device designed to produce quantitative results directly. The performance tests (precision, linearity, limits of detection, interference, and comparison to predicate devices) all evaluate the algorithm's and the device's ability to accurately measure without human intervention in the measurement process itself.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Comparison to Legally Marketed Predicate Devices: The primary method for demonstrating substantial equivalence is by comparing the BS-200 Chemistry Analyzer's results to those obtained from the previously cleared Boehringer Mannheim/Hitachi 917 Analyzer (for photometric assays like Glucose) and the EasyElectroLyte/RapidLyte Na/K/Cl Analyzer (for ISE assays). The predicate devices serve as the reference for accurate measurement.
Internal Validation Studies: Precision, linearity, limits of detection, and interference studies demonstrate the device's inherent analytical performance, with the understanding that these metrics are typically verified against established laboratory standards and methods.

8. The Sample Size for the Training Set

This information is not provided and is generally not relevant for 510(k) submissions of traditional clinical chemistry analyzers. These devices are typically developed and calibrated based on established chemical principles and known concentrations, rather than being "trained" in the machine learning sense on a large dataset.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is likely not applicable as per the explanation in point 8. The "training" in such devices involves calibration using materials with known, precisely determined concentrations, which serve as the reference standard.

Summary

{0}------------------------------------------------

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: +86 755 2658 2888 Fax: +86 755 2658 2680

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

{1}------------------------------------------------

Legally Marketed Predicate Device:

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

Description:

Intended Use:

Indications for Use:

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.

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

{2}------------------------------------------------

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	RegressionSlope	RegressionIntercept	CorrelationCoefficient(r)	Samplenumbers
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%

Page 3 of 5

{3}------------------------------------------------

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

{4}------------------------------------------------

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.

{5}------------------------------------------------

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).

{6}------------------------------------------------

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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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

{7}------------------------------------------------

Indication for Use

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

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.

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

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.