(126 days)
Not Found
No
The device description focuses on standard blood glucose and blood pressure measurement technologies (oscillometric method, capillary action for glucose) and basic data storage/display. There is no mention of AI, ML, or any advanced analytical techniques.
No.
The device is described as a measurement system to aid in monitoring the effectiveness of diabetes control and to measure blood pressure and pulse rate, which are diagnostic/monitoring functions, not therapeutic.
Yes
The device quantitatively measures glucose, systolic and diastolic blood pressure, and pulse rate, which are used as an aid to monitor the effectiveness of diabetes control and measure vital signs. These measurements serve to provide information that assists in the diagnosis, screening, or monitoring of diseases and conditions.
No
The device description clearly states it includes hardware components such as a meter with wrist cuff, test strips, lancets, lancing device, storage case, and control solution. It is a physical device that performs measurements.
Based on the provided text, the BGP-100 blood glucose and blood pressure measurement system is an IVD (In Vitro Diagnostic) device, but only for the blood glucose measurement component.
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states for the glucose measurement part: "Testing is done outside the body (In Vitro diagnostic use)."
- Nature of the Test: The blood glucose measurement involves analyzing a sample of whole blood taken from the fingertip outside the body. This is the definition of an in vitro diagnostic test.
The blood pressure measurement component is NOT an IVD.
Here's why:
- Nature of the Test: The blood pressure measurement is performed on the body using a wrist cuff and the oscillometric method. This is a physiological measurement taken directly from the patient, not a test performed on a sample outside the body.
Therefore, the BGP-100 system is a combination device where one part (glucose measurement) is an IVD and the other part (blood pressure measurement) is not.
N/A
Intended Use / Indications for Use
The BGP-100 blood glucose and blood pressure measurement system consists of a meter with rric DOF Too brood groot of the system is intended for use in the quantitative measurement of whice our and toot othpost the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX, DXN
Device Description
BGP-100 Sein Blood Glucose & Pressure Monitor system BGP-100 combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip blood or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Sein Electronics Co., Ltd has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30days. Control Solution is sold separately from the kit. BGP-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will be full with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for glucose measurement), Adult's wrist (for blood pressure and pulse rate measurement)
Indicated Patient Age Range
Adult's (for blood pressure and pulse rate measurement). Not intended for use on neonates (for glucose measurement).
Intended User / Care Setting
Home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals (for glucose measurement). Home care environment (for blood pressure and pulse rate measurement).
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
DEC 7 2005
K052/08
510(k) Summary
As Required by 21 section 807.92 ( c )
- Sein Electronics Co., Ltd 1 - Submitter Name: 133-3. Pyungchon-dong, Anyang-city, Kyunggi-do, Korea 2- Address: (82) 31-421-0389 3- Phone: (82) 31-467-2107 4- Fax: 5- Contact Person: Tae voung Choi August 1, 2005 6- Date summary prepared: Mansour Consulting LLC 7 - Official Correspondent: 1308 Morningside Park Dr. Alpharetta, GA 30022 USA 8- Address: 770-777-4146 9- Phone: 678-623-3765 10- Fax: Jay Mansour, President 11- Contact Person: 12- Device Trade or Proprietary Name: BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 Blood Glucose Monitor, Blood glucose test strips, quality 13- Device Common or usual name: control material, and Blood Pressure Monitor 14- Device Classification Name: System, test, blood glucose, over the counter Glucose oxidase, glucose Single (specified) analyte controls System, measurement, blood-pressure, non-invasive 15- Substantial Equivalency is claimed against the following device: Blood Pressure Monitor, Model SE-311, manufactured by Sein Electronics Co., Ltd. 510k #K042138 Clever Chek TD-3213, 510k# K042795
One Touch Ultra Blood Glucose monitoring system, 510k #K002134
16- Description of the Device:
BGP-100 Sein Blood Glucose & Pressure Monitor system BGP-100 combines the function of a blood glucose monitoring system and a blood pressure meter in one unit. Supplies with the meter are test strips, lancets, lancing device, storage case and control solution. The blood glucose monitoring system is turned on by strip insertion; Once the user confirms that the numerical code on the display, and strip bottle all match, a test strip is inserted into the meter and glucose testing can proceed. The user then supplies finger-tip blood or control solution to the strip and the meter starts the measurement, which is completed in 5 seconds. Sein Electronics Co., Ltd has provided instructions and illustrations explaining, that the blood drop will be pulled into the strip sample entry by capillary action until meter beeps and the result will be show on liquid crystal display ("LCD") after 5 seconds. Results are automatically stored in the meter's memory for tracking purposes. The capacity of memory is 150 blood glucose values and average value of past 14 days or 30days. Control Solution is sold separately from the kit. BGP-100 adopts the wrist type cuff for blood pressure meter part. The cuff and control unit are combined into a single wrist-mounted assembly. The user interface panel has power switch, mode switch, memory switch, for blood pressure meter part and LCD for displaying the systolic blood pressure, diastolic blood pressure, pulse rate, date and time. This device has the memory function that permits memory and display of the 60 most recent measurement results. User should wrap the pressure cuff around the wrist with the palm facing up and pushes the "Power" button. The cuff will be full with appropriate air pressure automatically. Pressurization is automatically governed. If the initial inflation pressure (180mmHg) is inadequate for measurement, i.e. lower that the patient's systolic pressure, the pump will automatically repressurize to a preset level (30 mmHg) above the initial level. Symbols in the LCD indicate pressurization status at all times. The air of cuff is automatically deflated during blood pressure measurement. No special training beyond basic ability to follow instruction is required. Since the products are designed for home use, detailed instructions on avoidance of practices that adversely affect the accuracy of measurements are included in the instruction manual.
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17- Intended use of the device: (refer to FDA form attached)
The BGP-100 blood glucose and blood pressure measurement system consists of a meter with rric DOF Too brood groot of the system is intended for use in the quantitative measurement of whice our and toot othpost the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates. Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.
18- Safety and Effectiveness of the device:
This device is safe and effective as the predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14- Summary comparing technological characteristics with predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SUBSTANTIALLY EQUIVALENT to the predicate device. Refer to the explanations/details within the main submission.
| FDA file reference number | 510k # K042138 | 510k # K042795 and 002134 |
|---|---|---|
| TECHNOLOGICAL | ||
| CHARACTERISTICS | Comparison result | |
| Indications for use | Identical | |
| Target population | Identical | |
| Design | ||
| Materials | ||
| Performance | ||
| Sterility | ||
| Biocompatibility | ||
| Mechanical safety | ||
| Chemical safety | ||
| Anatomical sites | ||
| Human factors | IDENTICAL | SIMILAR |
| Energy used and/or | ||
| delivered | ||
| Compatibility with | ||
| environment and other | ||
| devices | ||
| Where used | ||
| Standards met | ||
| Electrical safety | ||
| Thermal safety | ||
| Radiation safety |
Refer to the submission for more details.
Page 14
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
2005 DEC 7
Sein Electronics Co., Ltd. c/o Mr. Jay Mansour, MSQA, BE, LA, RAC President Mansour Consulting LLC 1308 Morningside Park Drive Alpharetta, GA 30022
Re: K052108
Trade/Device Name: Blood Glucose and Blood Pressure Monitor System, Model BGP-100 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX, DXN Dated: October 26, 2005 Received: October 31, 2005
Dear Mr. Mansour,
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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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow your to begin inding of substantial equivalence of your device to a legally promative nevice 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) 276-0484. 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 I vision of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guti
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K052108
Device Name: Blood Glucose and Blood Pressure Monitor System, Model BGP-100
Indications For Use:
The BGP-100 blood glucose and blood pressure measurement system consists of a meter with wrist cuff and test strips. The system is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.
Also the system measures systolic and diastolic blood pressure and pulse rate from adult's wrist in the home care environment. The device employs a wrist cuff and the oscillometric method of measurement.
Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use (21 CFR 801 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)
Carol C. Benson
Division Sign-Off
office of in vitro Diagnostic Device Evaluation and Safety
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