(219 days)
No
The summary describes a standard automated clinical chemistry analyzer using photometric and ion-selective electrode technology, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) device used for making measurements of various substances in serum, plasma, and urine samples. Its purpose is to aid in diagnosis and treatment, not to perform therapy.
Yes
The device is designed for clinical laboratory use to make direct quantitative measurements of various analytes (Na+, K+, Cl-, Glucose) in biological samples, and these measurements are explicitly stated as being used in the "diagnosis and treatment" of various diseases involving electrolyte imbalances, carbohydrate metabolism disorders, and other conditions. The term "diagnosis" directly indicates a diagnostic function.
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 medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the device 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 plasma and urine samples." It also mentions that these measurements are used in the "diagnosis and treatment" of various diseases and conditions. This clearly indicates the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description confirms it's an "automated clinical chemistry analyzer capable of performing various in vitro photometric assays." The term "in vitro" is a key indicator of an IVD.
- Performance Studies: The document details performance studies conducted on the device using biological samples (serum, plasma, urine) to evaluate metrics like precision, linearity, and method comparison. This type of testing is characteristic of IVD devices.
- Predicate Device(s): The mention of predicate devices like the "SYNCHRON CX7, BECKMAN" and "BS-200 Chemistry Analyzer, Mindray" (both of which are known IVD analyzers) further supports the classification of this device as an IVD.
The core function of the device is to analyze biological samples outside of the body to provide quantitative results that are used in the diagnosis and treatment of diseases, which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
75JJE, 75CRF, 75CEM, 75CGE, 75JGS, CFR, JGS, CEM, CGZ, JJE
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.
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 laboratories
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-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 the following results:
GLU (mg/dL): Regression slope 0.989, Regression intercept 1.31, Correlation coefficient square R² 0.999, Sample numbers 218
Serum K+ (mmol/L) (ISE): Regression slope 1.0139, Regression intercept 0.0384, Correlation coefficient square R² 0.9973, Sample numbers 40
Serum Na+ (mmol/L) (ISE): Regression slope 1.0101, Regression intercept -0.9322, Correlation coefficient square R² 0.9975, Sample numbers 40
Serum Cl- (mmol/L) (ISE): Regression slope 0.9837, Regression intercept 0.5059, Correlation coefficient square R² 0.9957, Sample numbers 40
Urine K+ (mmol/L) (ISE): Regression slope 0.9671, Regression intercept 2.1934, Correlation coefficient square R² 0.9996, Sample numbers 40
Urine Na+ (mmol/L) (ISE): Regression slope 1.0256, Regression intercept -13.841, Correlation coefficient square R² 0.9994, Sample numbers 40
Urine Cl- (mmol/L) (ISE): Regression slope 0.9981, Regression intercept 2.4059, Correlation coefficient square R² 0.9996, Sample numbers 40
Precision of Glucose test yielded the following results:
Serum Control 1: Sample 120, mean 56.3, Within Run SD 0.57, %CV 1.0%, Total SD 0.88, %CV 1.6%
Serum Pool 1: Sample 120, mean 117.0, Within Run SD 0.83, %CV 0.7%, Total SD 1.74, %CV 1.5%
Serum Control 2: Sample 120, mean 561.6, Within Run SD 3.42, %CV 0.6%, Total SD 6.84, %CV 1.2%
Urine Pool 1: Sample 117, mean 14.9, Within Run SD 0.26, %CV 1.7%, Total SD 0.32, %CV 2.1%
Urine Pool 2: Sample 117, mean 194.3, Within Run SD 1.08, %CV 0.6%, Total SD 1.91, %CV 1.0%
Urine Pool 3: Sample 120, mean 330.0, Within Run SD 1.80, %CV 0.5%, Total SD 2.95, %CV 0.9%
The Within-Run precision of ISE module test yielded the following results:
K serum(ISE) Level I: Mean 3.49, SD 0.02, CV% 0.54%
K serum(ISE) Level II: Mean 6.21, SD 0.03, CV% 0.43%
Na serum(ISE) Level I: Mean 128.1, SD 0.63, CV% 0.49%
Na serum(ISE) Level II: Mean 150.8, SD 0.50, CV% 0.33%
CL serum(ISE) Level I: Mean 84.8, SD 0.95, CV% 1.12%
CL serum(ISE) Level II: Mean 117.9, SD 0.51, CV% 0.44%
K Urine(ISE) Level I: Mean 21, SD 0.51, CV% 2.48%
K Urine(ISE) Level II: Mean 44, SD 0.00, CV% 0.00%
Na Urine(ISE) Level I: Mean 65, SD 1.60, CV% 2.46%
Na Urine(ISE) Level II: Mean 124, SD 1.81, CV% 1.47%
CL Urine(ISE) Level I: Mean 53, SD 1.08, CV% 2.03%
CL Urine(ISE) Level II: Mean 106, SD 1.15, CV% 1.08%
The Between-run imprecision of ISE module test yielded the following results:
K (mmol/L) serum(ISE) Level I: Mean 3.48, SD 0.03, CV% 0.78%
K (mmol/L) serum(ISE) Level II: Mean 6.17, SD 0.04, CV% 0.64%
Na (mmol/L) serum(ISE) Level I: Mean 129.1, SD 1.00, CV% 0.78%
Na (mmol/L) serum(ISE) Level II: Mean 150.4, SD 0.89, CV% 0.59%
CL (mmol/L) serum(ISE) Level I: Mean 85.1, SD 1.10, CV% 1.29%
CL (mmol/L) serum(ISE) Level II: Mean 117.1, SD 0.96, CV% 0.82%
K (mmol/L) Urine(ISE) Level I: Mean 21, SD 0.47, CV% 2.23%
K (mmol/L) Urine(ISE) Level II: Mean 44, SD 0.24, CV% 0.56%
Na (mmol/L) Urine(ISE) Level I: Mean 67, SD 3.19, CV% 4.75%
Na (mmol/L) Urine(ISE) Level II: Mean 126, SD 3.45, CV% 2.74%
CL (mmol/L) Urine(ISE) Level I: Mean 56, SD 2.13, CV% 3.83%
CL (mmol/L) Urine(ISE) Level II: Mean 108, SD 2.02, CV% 1.87%
The linearity test yielded the following results:
GLU (mg/dL) (Specimen: Serum/Plasma): Linear range Lower limit 5, Upper limit 700
GLU (mg/dL) (Specimen: Urine): Linear range Lower limit 2, Upper limit 700
K (mmol/L) serum(ISE): Linear range Lower limit 0.94, Upper limit 8.18
Na (mmol/L) serum(ISE): Linear range Lower limit 71.00, Upper limit 232.28
CL (mmol/L) serum(ISE): Linear range Lower limit 49.60, Upper limit 198.18
K (mmol/L)Urine(ISE): Linear range Lower limit 3.50, Upper limit 209.25
Na (mmol/L) Urine(ISE): Linear range Lower limit 9.25, Upper limit 725.50
CL (mmol/L)Urine(ISE): Linear range Lower limit 7.25, Upper limit 693.25
The Limit of Detection test yielded the following results:
GLU (mg/dL) (Specimen: Serum): LoB 2.2, LoD 2.6, LoQ /
GLU (mg/dL) (Specimen: Urine): LoB 0.6, LoD 0.9, LoQ /
K (mmol/L) serum(ISE): LoB 0.07, LoD 0.10, LoQ 0.52
Na (mmol/L) serum(ISE): LoB 1.28, LoD 2.06, LoQ 4.38
CL (mmol/L) serum(ISE): LoB 2.30, LoD 3.56, LoQ 5.12
K (mmol/L) Urine(ISE): LoB 1.50, LoD 2.42, LoQ 3.70
Na (mmol/L) Urine(ISE): LoB 5.50, LoD 8.98, LoQ 10.98
CL (mmol/L)Urine(ISE): LoB 3.50, LoD 5.91, LoQ 7.15
The Interference of Glucose test yielded the following results:
Ascorbic acid: Glucose Concentration 76 mg/dL, 140 mg/dL, Interferent Concentration 30 mg/L, Observed Interference none
Bilirubin: Glucose Concentration 78 mg/dL, 138 mg/dL, Interferent Concentration 5.4 mg/dL, 9.8 mg/dL, Observed Interference -3%, -3%
Hemoglobin: Glucose Concentration 74 mg/dL, 134 mg/dL, Interferent Concentration 400 mg/dL, Observed Interference none
Lipemia (from Intralipid®): Glucose Concentration 72 mg/dL, 139 mg/dL, Interferent Concentration 400 mg/dL, 67 mg/dL, Observed Interference + 3.1 mg/dL, +3%*
Metronidazole: Glucose Concentration 75 mg/dL, 137 mg/dL, Interferent Concentration 27 mg/L, 35 mg/L, Observed Interference + 3 mg/dL*, +3%*
Tetracycline: Glucose Concentration 76 mg/dL, 140 mg/dL, Interferent Concentration 15 mg/L, Observed Interference none
EDTA: Glucose Concentration 76 mg/dL, 145 mg/dL, Interferent Concentration 8 mg/mL, Observed Interference none
Potassium oxalate: Glucose Concentration 76 mg/dL, 146 mg/dL, Interferent Concentration 8 mg/dL, Observed Interference none
Sodium citrate: Glucose Concentration 76 mg/dL, 145 mg/dL, Interferent Concentration 140 mg/dL, Observed Interference none
Sodium fluoride: Glucose Concentration 77 mg/dL, 145 mg/dL, Interferent Concentration 10 mg/dL, Observed Interference none
The Interference of ISE module test yielded the following results:
Serum K+ (mmol/L): Hemoglobin >500 mg/dL, Bilirubin >40 mg/dL, Lipemia Intralipids® >1000 mg/dL
Serum Na+ (mmol/L): Hemoglobin >500 mg/dL, Bilirubin >40 mg/dL, Lipemia Intralipids® >1000 mg/dL
Serum Cl- (mmol/L): Hemoglobin >500 mg/dL, Bilirubin >40 mg/dL, Lipemia Intralipids® >1000 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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:
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.
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 | Regression
slope | Regression intercept | Correlation
coefficient
square R² | Sample
numbers |
|--------------------------|---------------------|----------------------|-----------------------------------------|-------------------|
| 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 |
・
30
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 | Glucose
Concentration | Interferent
Concentration | Observed
Interference |
|-------------------------------|--------------------------|------------------------------|--------------------------|
| Ascorbic acid | 76 mg/dL
140 mg/dL | 30 mg/L | none |
| Bilirubin | 78 mg/dL
138 mg/dL | 5.4 mg/dL
9.8 mg/dL | -3%*
-3%* |
| Hemoglobin | 74 mg/dL
134 mg/dL | 400 mg/dL | none |
| Lipemia (from
Intralipid®) | 72 mg/dL
139 mg/dL | 400 mg/dL
67 mg/dL | + 3.1 mg/dL
+3%* |
31
5
510 (k) Summary
| Metronidazole | 75 mg/dL | 27 mg/L | + 3 mg/dL* |
|---|---|---|---|
| 137 mg/dL | 35 mg/L | + 3%* | |
| Tetracycline | 76 mg/dL | ||
| 140 mg/dL | 15 mg/L | none | |
| EDTA | 76 mg/dL | ||
| 145 mg/dL | 8 mg/mL | none | |
| Potassium oxalate | 76 mg/dL | ||
| 146 mg/dL | 8 mg/dL | none | |
| Sodium citrate | 76 mg/dL | ||
| 145 mg/dL | 140 mg/dL | none | |
| Sodium fluoride | 77 mg/dL | ||
| 145 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.
N
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:
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.
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