The BS-400/CLC 720 Chemistry Analyzers are 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 plasma and urine 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-400/CLC 720 Chemistry Analyzer is an automated clinical chemistry analyzer capable of performing various in vitro photometric assays. The Glucose was cleared under K970664 and is the chosen assay to demonstrate performance for the photometric unit. The BS-400 Chemistry Analyzer has an optional lon-Selective Electrode (ISE) module which measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using ion selective electrode technology.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, extracting the requested information about the device's acceptance criteria and the supporting study:

The document describes the Shenzhen Mindray Bio-medical Electronics Co., LTD BS-400 Chemistry Analyzer (and CLC 720 Chemistry Analyzer, which is stated to be the same model). The device is an automated clinical chemistry analyzer for in vitro diagnostic use, performing photometric assays and having an optional Ion-Selective Electrode (ISE) module.

Summary of Acceptance Criteria and Device Performance:

The primary method for demonstrating performance is through correlation analysis with predicate devices and internal precision, linearity, and limit determination tests. The acceptance criteria are implicitly defined by the reported performance metrics falling within acceptable ranges for clinical diagnostic devices.

Performance Characteristic	Analyte	Acceptance Criteria (Implicit)	Reported Device Performance
Correlation Coefficient (R²)	GLU (mg/dL)	Close to 1.0	0.999
	Serum K+ (mmol/L) (ISE)	Close to 1.0	0.9973
	Serum Na+ (mmol/L) (ISE)	Close to 1.0	0.9975
	Serum Cl- (mmol/L) (ISE)	Close to 1.0	0.9957
	Urine K+ (mmol/L) (ISE)	Close to 1.0	0.9996
	Urine Na+ (mmol/L) (ISE)	Close to 1.0	0.9994
	Urine Cl- (mmol/L) (ISE)	Close to 1.0	0.9996
Within Run Precision (%CV)	Glucose (ranges by concentration)	Low %CV	0.6% - 1.7%
	ISE analytes (ranges by level)	Low %CV	0.33% - 2.48%
Total Precision (%CV)	Glucose (ranges by concentration)	Low %CV	0.9% - 2.1%
Between-Run Imprecision (%CV)	ISE analytes (ranges by level)	Low %CV	0.56% - 4.75%
Linearity Range (Lower/Upper Limits)	GLU (mg/dL) Serum/Plasma	Defined clinical range	5 - 700
	GLU (mg/dL) Urine	Defined clinical range	2 - 700
	K (mmol/L) serum(ISE)	Defined clinical range	0.94 - 8.18
	Na (mmol/L) serum(ISE)	Defined clinical range	71.00 - 232.28
	CL (mmol/L) serum(ISE)	Defined clinical range	49.60 - 198.18
	K (mmol/L) Urine(ISE)	Defined clinical range	3.50 - 209.25
	Na (mmol/L) Urine(ISE)	Defined clinical range	9.25 - 725.50
	CL (mmol/L) Urine(ISE)	Defined clinical range	7.25 - 693.25
Limit of Detection (LoD)	GLU (mg/dL) Serum/Urine	Low LoD	2.6 / 0.9
	ISE analytes	Low LoD	0.10 - 8.98
Interference (Implicit Criterion)	Shift in results	< 3 mg/dL and < 3%	Generally "none" or qualified minimal shift

Study Details:

Sample sizes used for the test set and data provenance:
- Correlation Analysis (Method Comparison):
  - GLU: 218 samples
  - Serum K+, Na+, Cl- (ISE): 40 samples each
  - Urine K+, Na+, Cl- (ISE): 40 samples each
- Precision (Glucose):
  - Control 1, Pool 1, Control 2 (Serum): 120 replicates each
  - Pool 1, Pool 2 (Urine): 117 replicates each
  - Pool 3 (Urine): 120 replicates
- Within-Run Imprecision (ISE): Replicates for Level I and Level II controls/pools for each ISE analyte (number of replicates not explicitly stated, but common practice for this type of test involves significant replication, e.g., 20 or more per run).
- Between-Run Imprecision (ISE): Replicates for Level I and Level II controls/pools for each ISE analyte across multiple runs (number of replicates and runs not explicitly stated).
- Linearity, Limit of Detection, Interference: Sample sizes are not explicitly stated for individual tests but would involve multiple measurements across a range of concentrations or with interfering substances.
Data Provenance: Not explicitly stated. However, this type of performance testing is typically conducted in a laboratory setting, often in the manufacturer's R&D facilities or a collaborating clinical lab. The document does not specify country of origin for the data (e.g., China, US) nor whether it was retrospective or prospective, though performance evaluation studies are typically prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For this type of device (clinical chemistry analyzer), "ground truth" is established by comparative measurements against a legally marketed predicate device (SYNCHRON CX7 for photometric assays like Glucose, and BS-200 Chemistry Analyzer for ISE module) or using reference methods.
- Expert review for result interpretation (e.g., radiologist for imaging) is not applicable here. The "ground truth" is quantitative measurements from established, validated laboratory methods.
Adjudication method for the test set:
- Not applicable as this is a quantitative analytical device comparison and performance characterization, not subjective interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/imaging device that involves human reader interpretation. It's an automated clinical chemistry analyzer.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics (precision, linearity, limits of detection, interference) are all measures of the analyzer's standalone performance, i.e., the algorithm/instrument only, without human intervention in the assay execution or result calculation once initialized. The correlation analysis also assesses the device's standalone performance against a predicate device.
The type of ground truth used:
- Comparative Reference: For the correlation analysis, the results from the SYNCHRON CX7 analyzer (for photometric assays like Glucose) and the BS-200 Chemistry Analyzer (for the ISE module) served as the comparative "reference" or "ground truth" for demonstrating substantial equivalence. These are legally marketed predicate devices.
- Internal Validation Metrics: For precision, linearity, and limits of detection, the "ground truth" is derived from statistical models and expected performance ranges based on established analytical chemistry principles and industry standards for in vitro diagnostic devices. These are not external "ground truths" in the sense of a gold-standard clinical outcome or pathology.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a distinct "training set" in the conventional sense. The device's operational parameters and calibration curves are established through a different process than machine learning model training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device. The calibration and operational parameters are set using known standards and calibrators according to established analytical chemistry protocols.

Summary

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

KI12377

MAR 2 3 2012

510 (k) Summary

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: _ ______________

Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

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

Contact Person:
- Tan Chuanbin

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Date Prepared:
July 26, 2011

Name of the device:

. Trade/Proprietary Name: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer
(BS-400 and CLC 720 are the same analyzers except the Models. For convenience of explanation, the BS-400 Chemistry Analyzer is represented of the two in this summary.)
. Common Name: Clinical Chemistry Analyzer (with optional ISE Module)
Classification Number/Class: ●

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

Page 1 of 6

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

75CGE, Class II 75JGS, Class II

Legally Marketed Predicate Device:

SYNCHRON CX7, BECKMAN K904219 K072018 BS-200 Chemistry Analyzer, Mindray K970664 GLUCOSE REAGENT, DERMA MEDIA LAB., INC.

Description:

Intended Use:

The BS-400 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.

Comparison of Technological Characteristics:

Substantial equivalence has been demonstrated between the BS-400 Chemistry Analyzer and SYNCHRON CX7 analyzer. Both of them utilize absorbance photometry to perform and output quantitative results for kinetic and endpoint clinical chemistries. For analytes, the BS-400 Chemistry Analyzer and SYNCHRON CX7 analyzer determine the concentration of unknown samples from a standard curve generated with known analyte concentrations. The BS-400 Chemistry Analyzer and BS-200 Chemistry Analyzer both utilize Ion-Selective Electrodes technology and are equipped with the same ISE Module.

Performance Characteristics:

Performance testing of the BS-400 Chemistry Analyzer consisted of running the FDA previously cleared assay and the ISE module on the BS-400 to evaluate precision, linearity, and method comparison, Limits of Detection and Limits of Quantitation, interference.

A correlation analysis between the BS-400 Chemistry Analyzer and the predicate devices yielded

Page 2 of 6

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

510 (k) Summary

the following results:

Item	Regressionslope	Regression intercept	Correlationcoefficientsquare R²	Samplenumbers
GLU (mg/dL)	0.989	1.31	0.999	218
Serum K+ (mmol/L) (ISE)	1.0139	0.0384	0.9973	40
Serum Na+ (mmol/L) (ISE)	1.0101	-0.9322	0.9975	40
Serum Cl- (mmol/L) (ISE)	0.9837	0.5059	0.9957	40
Urine K+ (mmol/L) (ISE)	0.9671	2.1934	0.9996	40
Urine Na+ (mmol/L) (ISE)	1.0256	-13.841	0.9994	40
Urine Cl- (mmol/L) (ISE)	0.9981	2.4059	0.9996	40

Precision of Glucose test yielded the following results:

・

. .

Specimen	Sample	n	mean	Within Run		Total
				SD	%CV	SD	%CV
Serum
	Control 1	120	56.3	0.57	1.0%	0.88	1.6%
	Pool 1	120	117.0	0.83	0.7%	1.74	1.5%
	Control 2	120	561.6	3.42	0.6%	6.84	1.2%
Urine
	Pool 1	117	14.9	0.26	1.7%	0.32	2.1%
	Pool 2	117	194.3	1.08	0.6%	1.91	1.0%
	Pool 3	120	330.0	1.80	0.5%	2.95	0.9%

The Within-Run precision of ISE module test yielded the following results:

Page 3 of 6

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

	Item	Level I			Level II
		Mean	SD	CV%	Mean	SD	CV%
K serum(ISE)	3.49	0.02	0.54%	6.21	0.03	0.43%
Na serum(ISE)	128.1	0.63	0.49%	150.8	0.50	0.33%
CL serum(ISE)	84.8	0.95	1.12%	117.9	0.51	0.44%
K Urine(ISE)	21	0.51	2.48%	44	0.00	0.00%
Na Urine(ISE)	65	1.60	2.46%	124	1.81	1.47%
CL Urine(ISE)	53	1.08	2.03%	106	1.15	1.08%

The Between-run imprecision of ISE module test yielded the following results:

Item	Level I			Level II
	Mean	SD	CV%	Mean	SD	CV%
K ( mmol/L )serum(ISE)	3.48	0.03	0.78%	6.17	0.04	0.64%
Na ( mmol/L )serum(ISE)	129.1	1.00	0.78%	150.4	0.89	0.59%
CL ( mmol/L )serum(ISE)	85.1	1.10	1.29%	117.1	0.96	0.82%
K ( mmol/L )Urine(ISE)	21	0.47	2.23%	44	0.24	0.56%
Na ( mmol/L )Urine(ISE)	67	3.19	4.75%	126	3.45	2.74%
CL ( mmol/L )Urine(ISE)	56	2.13	3.83%	108	2.02	1.87%

The linearity test yielded the following results: ·

Item	Linear range
	Lower limit	Upper limit
GLU ( mg/dL )(Specimen :Serum/Plasma)	5	700
GLU (mg/dL) (Specimen :Urine)	2	700

・

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

510 (k) Summary

K (mmol/L) serum(ISE)	0.94	8.18
Na (mmol/L) serum(ISE)	71.00	232.28
CL (mmol/L) serum(ISE)	49.60	198.18
K (mmol/L)Urine(ISE)	3.50	209.25
Na (mmol/L) Urine(ISE)	9.25	725.50
CL (mmol/L)Urine(ISE)	7.25	693.25

The Limit of Detection test yielded the following results:

Item	LoB	LoD	LoQ
GLU (mg/dL) (Specimen :Serum)	2.2	2.6	/
GLU (mg/dL) (Specimen :Urine)	0.6	0.9	/
K (mmol/L) serum(ISE)	0.07	0.10	0.52
Na (mmol/L) serum(ISE)	1.28	2.06	4.38
CL (mmol/L) serum(ISE)	2.30	3.56	5.12
K (mmol/L) Urine(ISE)	1.50	2.42	3.70
Na (mmol/L) Urine(ISE)	5.50	8.98	10.98
CL (mmol/L)Urine(ISE)	3.50	5.91	7.15

The Interference of Glucose test yielded the following results:

Effects of icterus, hemolysis, and lipemia are shown by spiking serum pools with bilirubin, hemoglobin, and Intralipid® 20% emulsion. Other substances are also tested. Interference is defined as a shift in results by more than both 3 mg/dL and 3%.

Interferent	GlucoseConcentration	InterferentConcentration	ObservedInterference
Ascorbic acid	76 mg/dL140 mg/dL	30 mg/L	none
Bilirubin	78 mg/dL138 mg/dL	5.4 mg/dL9.8 mg/dL	-3%-3%
Hemoglobin	74 mg/dL134 mg/dL	400 mg/dL	none
Lipemia (fromIntralipid®)	72 mg/dL139 mg/dL	400 mg/dL67 mg/dL	+ 3.1 mg/dL+3%*

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

510 (k) Summary

Metronidazole	75 mg/dL	27 mg/L	+ 3 mg/dL*
	137 mg/dL	35 mg/L	+ 3%*
Tetracycline	76 mg/dL140 mg/dL	15 mg/L	none
EDTA	76 mg/dL145 mg/dL	8 mg/mL	none
Potassium oxalate	76 mg/dL146 mg/dL	8 mg/dL	none
Sodium citrate	76 mg/dL145 mg/dL	140 mg/dL	none
Sodium fluoride	77 mg/dL145 mg/dL	10 mg/dL	none

*Amount of interference is interpolated from the results of adjacent spiked samples.

The Interference of ISE module test yielded the following results:

Item	Interference materials
	Hemoglobin	Bilirubin	Lipemia Intralipids®
Serum K+ (mmol/L)	>500 mg/dL	>40 mg/dL	>1000 mg/dL
Serum Na+ (mmol/L)	>500 mg/dL	>40 mg/dL	>1000 mg/dL
Serum Cl- (mmol/L)	>500 mg/dL	>40 mg/dL	>1000 mg/dL

Conclusion:

The data demonstrates that the BS-400 Chemistry Analyzer is substantially equivalent to SYNCHRON CX7 Analyzer and BS-200 Chemistry Analyzer.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure in profile, with three overlapping heads facing to the right.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

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

MAR 2 3 2012

Re: K112377

Trade/Device Name: BS-400/CLC 720 Chemistry Analyzer · Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CFR, JGS, CEM, CGZ, JJE Dated: March 9, 2012 Received: March 12, 2012

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely vours.

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use

510(k) Number (if known): K112377

Device Name: BS-400/CLC 720 Chemistry Analyzer

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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Omoce Evaluation and Safety

510(k) K(112327)

Page 1 of

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.