SD LipidoCare BT Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LipidoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare BT Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare BT Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare BT Professional Blood Glucose Test Strips are for use with SD LipidoCare BT Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professionals. SD LipidoCare BT Profile Test Strips are intended for use with the SD LipidoCare BT Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare Home System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Home System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use).

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LipidoCare Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertip. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatments with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, and triglycerides.

SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

Device Description

SD LipidoCare (BT) Professional/Home Analyzer can measure TC, TG, HDL, and Glucose, and it also can calculate LDL and non-HDL using the blood sample from the human with the SD LipidoCare (BT) Profiessional/Home Lipid Profile and SD LipidoCare (BT) Professional/Home Glucose test strips. This system is portable using batteries for power source and can store up to 500 test results in the memory. Users can search the stored results and can review the average results for 7, 15 and 30 day glucose test results. The average calculation function is for glucose test results only. This system can set the beep, date, time, unit, auto printing, simplex/duplex printing, hypo warning for glucose, alarms and Bluetooth. The analyzer offers 2 models: one with Bluetooth function for printing the test results and transferring data to a PC via Bluetooth technology and the other without it. The analyzer without the Bluetooth unit can still print the test results and transfer the data to a PC using a cable.

The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor.

There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing.

The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the SD LipidoCare systems, based on the provided document:

The document combines information for four devices: SD LipidoCare Home System, SD LipidoCare Professional System, SD LipidoCare BT Home System, and SD LipidoCare BT Professional System. All four systems are intended for the quantitative measurement of glucose, total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood. The "BT" versions add Bluetooth functionality.

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study report with explicit acceptance criteria for each performance metric. Therefore, some information, particularly around specific acceptance criteria values and the detailed methodology of how "ground truth" was established, is inferred or generalized from the context of substantial equivalence testing for IVD devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for the subject devices (SD LipidoCare systems). Instead, it relies on demonstrating substantial equivalence to predicate devices. However, it does list the test ranges for both the predicate and new devices, which can be seen as the operational range where performance is expected to be acceptable. Performance is generally presented as "substantially equivalent" rather than with specific quantifiable metrics against a pre-defined criterion table.

Inferred Performance and Comparison:

Attribute	Predicate: PTS PANELS Lipid Panel Test Strips	New Devices: SD LipidoCare (BT) Professional/Home (Lipid)	Predicate: SmartLink™ GOLD Blood Glucose Monitoring System	New Devices: SD LipidoCare (BT) Professional/Home (Glucose)
Test Range (Lipid)
TC	100-400 mg/dL (2.59-10.36 mmol/L)	100-450 mg/dL (2.59-11.6 mmol/L)	N/A	N/A
TG	50-500 mg/dL (0.57-5.65 mmol/L)	45-650 mg/dL (0.51-7.43 mmol/L)	N/A	N/A
HDL	15-100 mg/dL (0.57-2.59 mmol/L)	25-95 mg/dL (0.65-2.46 mmol/L)	N/A	N/A
Hematocrit Range (Lipid)
TC	30-50%	30-52%	N/A	N/A
TG	15-55%	30-52%	N/A	N/A
HDL	30-45%	30-52%	N/A	N/A
Test Range (Glucose)	N/A	N/A	20-600 mg/dL (1.2-33.3 mmol/L)	IDENTICAL (20-600 mg/dL)
Hematocrit Range (Glucose)	N/A	N/A	20-60%	IDENTICAL (20-60%)
Other Differences Not Quantified Against Criteria
Test time (Lipid)	1-2 minutes	3 minutes	N/A	N/A
Operating Temp. (Lipid)	20-27°C	64-90°F (10-90% RH)	N/A	N/A
Memory (Lipid)	300 tests	500 tests	N/A	N/A
Operating Temp. (Glucose)	N/A	N/A	10-45°C (50-113°F)	64-90°F
Power Supply (Glucose)	CR 2032 Type	N/A	CR 2032 Type	Four 1.5V AA Alkaline batteries
Size (Glucose)	4.7 x 9.5 x 1.75 (mm)	N/A	4.7 x 9.5 x 1.75 (mm)	6.72 x 13.3 x 2.85 (cm)

Acceptance Criteria Implication: For many IVD devices, acceptance criteria often relate to accuracy (bias, precision), linearity, interference, and user performance. The document states that "We performed various clinical and bench tests and the test results supported that despite these differences the [subject device is] substantially equivalent to the predicate devices." This implies that the performance of the new devices, within their specified (and sometimes wider) ranges, met the accepted performance characteristics typically associated with the predicate devices, thereby not raising questions of safety and effectiveness.

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

The document does not specify the sample size used for the "clinical and bench tests" that demonstrated substantial equivalence.

Data Provenance: The manufacturer is SD Biosensor, Inc. from the Republic of Korea. The document does not explicitly state whether the data was retrospective or prospective, but clinical and bench testing for 510(k) submissions are typically prospective studies designed to evaluate the new device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish ground truth. For in vitro diagnostic (IVD) devices measuring biomarkers, ground truth is typically established using established laboratory reference methods performed by qualified laboratory personnel, rather than expert consensus on image interpretation.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method. For quantitative measurements by IVD devices, adjudication (like 2+1 or 3+1 for imaging studies) is generally not applicable in the same way. The comparison is usually made directly against a reference method.

5. 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where AI assists human readers. The SD LipidoCare systems are in vitro diagnostic devices for quantitative measurement of blood analytes.

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

The device itself is a standalone measurement system (analyzer and test strips). Its performance is inherently "standalone" in the sense that it provides a quantitative result without direct human interpretation of complex visual data or complex human-AI interaction. The "clinical and bench tests" would have evaluated this standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For IVD devices measuring analytes like glucose, total cholesterol, triglycerides, and HDL cholesterol, the ground truth is typically established using reference laboratory methods (e.g., enzymatic colorimetric methods on a chemistry analyzer) operated by trained laboratory professionals. These methods are considered the gold standard for accurate quantitative measurements for these specific analytes in blood. The document implies this approach through its discussion of "Substantial Equivalence," which generally means the device's results correlate sufficiently with established laboratory methods.

8. The Sample Size for the Training Set

The document does not specify the sample size for a "training set." These devices typically do not involve AI algorithms that require explicit "training sets" in the conventional machine learning sense. Their performance is based on the chemical and enzymatic reactions within the test strips and the photometric/biosensor reading technology, which are validated through analytical and clinical studies.

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

As noted above, a "training set" in the machine learning sense is not applicable here. The device's underlying principles (e.g., enzymatic reactions for glucose, photometric reading for lipids) are based on established scientific methods. Any calibration or internal adjustments made during manufacturing (which would be analogous to "training" in a very broad sense) would be done against reference standards, with the "ground truth" being the known concentrations of those reference standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 17, 2017

SD BIOSENSOR C/O PRISCILLA CHUNG LK CONSULTING GROUP USA, INC. 2651 E CHAPMAN AVE STE 110 FULLERTON CA 92831

Re: K160282 Trade/Device Name: SD LipidoCare Home System SD LipidoCare Professional System SD LipidoCare BT Home System SD LipidoCare BT Professional System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CHH, JGY, LBR Dated: October 9, 2017 Received: October 12, 2017

Dear Priscilla Chung:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K160282

Device Name SD LipidoCare BT Home System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
------------------------------------------------------------	-----------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K160282

Device Name SD LipidoCare BT Professional System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K160282

Device Name SD LipidoCare Home System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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510(k) Number (if known) K160282

Device Name SD LipidoCare Professional System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------	---------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Image /page/6/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange abstract symbol resembling a stylized "Y" inside a circle, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black, with the company name written in a clear, sans-serif font.

510(k) Summary

(K160282)

This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.

Date of Summary: October 17, 2017

1. SUBMITTER:

Manufacturer

SD Biosensor, Inc. C-4th&5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, REPUBLIC OF KOREA 443-813 Tel : +82-31-300-0423 Fax : +82-31-300-0497

Contact Person

Ms. SunYoung Jeong / Regulatory Email: syj@sdbiosensor.com Official Correspondent (U.S. designated agent) Priscilla Chung (Regulatory Consultant) SD Biosensor, Inc. c/o LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 TEL: (714) 202-5789 FAX: (714) 409-3357 E-MAIL: juhee.c@lkconsultinggroup.com

2. DEVICE NAME:

Proprietary Name:	SD LipidoCare Home SystemSD LipidoCare Professional SystemSD LipidoCare BT Home SystemSD LipidoCare BT Professional System
Common Name:	Blood Glucose Monitoring SystemCholesterol Monitoring System
Classification:	21 CFR 862.1345, Product Code: NBW (Class II)Glucose test system21 CFR 862.1175, Product Code: CHH (Class I, meets limitations ofexemptions per 21 CFR 862.9 (c)(4).)Cholesterol (total) test system21 CFR 862.1705, Product Code: JGY (Class I, meets limitations ofexemptions per 21 CFR 862.9 (c)(4).)Triglyceride test system

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Image /page/7/Picture/0 description: The image shows the logo for SD Biosensor, Inc. The logo consists of an orange abstract symbol on the left, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black. The text is in a simple, sans-serif font.

▪ 21 CFR 862.1475, Product Code: LBR (Class I, meets limitations of exemptions per 21 CFR 862.9 (c)(4).) Lipoprotein test system

3. PREDICATE DEVICES:

PTS PANELS Lipid Panel Test Strips by POLYMER TECHNOLOGY SYSTEMS, INC. (K023558) SmartLink™ GOLD Blood Glucose Monitoring System by SD Biosensor, Inc. (K100398)

4. DEVICE DESCRIPTION:

The system includes Lipid Profile Test Strip which is based on a reflectance photometry, and Glucose Test Strip which is based on glucose oxidase biosensor.

There are also lipid check strips and glucose check the internal malfunction (or problem) of the analyzer prior to testing.

The code chip is for the analyzer to read the lot-specific characteristics of the test strips currently in use. The SD Ezi Tube+ is used to apply blood sample for lipid profile testing.

5. INDICATION FOR USE:

SD LipidoCare Home System

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and yarious liver and diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, HDL cholesterol, and triglycerides.

SD LipidoCare Home Blood Glucose Test Strips are for use with SD LipidoCare Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare Home Lipid Profile Test Strips are intended for use with the SD LividoCare Home Analyzer to quantitatively measure total cholesterol (TC), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare Professional System

SD LividoCare Professional System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, forearm or upper arm; and to measure total cholesterol (TC),

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Image /page/8/Picture/0 description: The image contains the logo for SD Biosensor, Inc. The logo features an orange abstract symbol on the left, followed by the letters "SD" in gray. To the right of "SD" is the text "SD BIOSENSOR, INC." in black. The text is in a simple, sans-serif font.

triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood from the fingertin. SD LipidoCare Professional System is intended to be used by lay-users and medical professionals. It is intended to be used by a single person and should not be shared. It is intended for testing outside the body (in vitro diagnostic use).

The glucose testing system is for people with diabetes as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LividoCare Professional System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, HDL cholesterol, and triglycerides.

SD LipidoCare Professional Blood Glucose Test Strips are for use with SD LipidoCare Professional Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by lay users and medical professional Lipid Profile Test Strips are intended for use with the SD LipidoCare Professional Analyzer to be used to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by lay users and medical professionals.

SD LipidoCare BT Home System

The glucose testing system is for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Glucose testing with the SD LipidoCare BT Home System should not be used for the diagnosis of or screening for diabetes and is not for use in neonates. For glucose testing, alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diamosis and treatment of livid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, HDL cholesterol, and triglycerides.

SD LipidoCare BT Home Blood Glucose Test Strips are for use with SD LipidoCare BT Home Analyzer to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, palm, forearm, or upper arm by a single person and should not be shared. SD LipidoCare BT Home Lipid Profile Test Strips are intended for use with the SD LividoCare BT Home Analyzer to quantitatively measure total cholesterol (TC), triglycerides (TG), and HDL cholesterol (HDL) in capillary whole blood by a single person and should not be shared.

SD LipidoCare BT Professional System

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SENSOR, INC.

C-4th&5th, 16, Deogyeong-Daero, 1556beon-Gil, Yeongtong-Gu, Suwon-si, Gyeonggi-Do, KOREA, REPUBLIC OF 443-813

steady-state times (when glucose is not changing rapidly). Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephoris, liver obstruction, other diseased involving lipid metabolism, or various endocrine disorders. Use the lipid profile test system at the frequency your doctor recommends testing for total cholesterol, HDL cholesterol, and triglycerides.

6. COMPARISION TO PREDICATE DEVICE:

The SD LividoCare (BT) Professional System and SD LividoCare (BT) Home System are substantially equivalent to PTS PANELS Lipid Panel Test Strips (K023558, K022401) and SmartLink™ GOLD Blood Glucose Monitoring System (K100398).

The subject and the predicate devices are similar in intended use and basic fundamental scientific technology. Please refer to the following similarities and difference comparison chart. The table below demonstrates the overall substantial equivalence of the new SD LipidoCare (BT) Professional and Home systems with the predicate devices.

Attribute	Predicate:PTS PANELS Lipid Panel Test Strips	New Devices:SD LipidoCare (BT) Professional/Home
510(k) Number	• K023558
Device Names	PTS PANELS Lipid Panel Test Strips	• SD LipidoCare (BT) Professional and Home Analyzer• SD LipidoCare (BT) Professional and Home Lipid Profile Test Strip
Manufacturer	POLYMER TECHNOLOGY SYSTEMS, INC.	SD Biosensor, Inc.
Intended Use	To measure total cholesterol, triglycerides and HDL cholesterol in capillary whole blood.	Identical
Assay method	Dry chemistry	IDENTICAL
Test time	1-2 minutes	3 minutes
Sample Type	Capillary whole blood	Capillary whole blood
Sample Volume	35-40μL	35μL
HematocritRange	• TC: 30-50%• TG: 15-55%• HDL: 30-45%	30-52%
Test Range	• TC: 100-400mg/dL(2.59-10.36mmol/L)• TG: 50-500mg/dL(0.57-5.65mmol/L)• HDL: 15-100mg/dL(0.57-2.59mmol/L)	• TC: 100-450 mg/dL(2.59-11.6mmol/L)• TG: 45-650 mg/dL(0.51-7.43 mmol/L)• HDL: 25-95 mg/dL(0.65-2.46 mmol/L)
Operating Temp.	20-27°C	64-90°F (10-90% RH)
Calibration	MEMO Chip	IDENTICAL
Memory	300 tests	500 tests
Display	LCD displays	IDENTICAL
Power Supply	Two 1.5V AAA Alkaline batteries	Four 1.5V AA Alkaline batteries
Size	13.97 × 7.62 × 2.54 (cm)	6.72 × 13.3 × 2.85 (cm)
Calibration	MEMO Chip	IDENTICAL

6.1. Lipid Measurement

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Substantial Equivalence Discussion

Similarities

Intended Use
. Principle of operation
Test Procedures
Display method
. Sample Type

Both the predicate and the subject device have the similar intended use, principle of operation, display method, and sample type.

1. Differences
- Testing range .
- . Hematocrit limit range
- Operating conditions (temperature range)
- Testing time
- Memory capacity

There are differences in testing range, hematocrit limit range, operating conditions (temperature range), testing time, and memory capacity between the two devices. We performed various clinical and bench tests and the test results supported that despite these differences the substantially equivalent to the predicate devices.

6.2. Glucose Measurement

Attribute	Predicate:SmartLink™ GOLD Blood GlucoseMonitoring System	New Devices:SD LipidoCare (BT)Professional/Home
510(k) Number	K100398
Device Names	SmartLink™ GOLD Blood GlucoseMonitoring System	SD LipidoCare Blood Glucose Test Strip
Manufacturer	SD Biosensor, Inc.	SD Biosensor, Inc.
Intended Use	For the quantitative measurement ofglucose in capillary whole blood.	Identical
Assay method	Electronic chemistry	IDENTICAL
Test time	5 seconds	IDENTICAL
Sample Type	Capillary whole blood drawn fromfingertip, palm, forearm and upper arm	IDENTICAL
Sample Volume	0.9uL	IDENTICAL
HematocritRange	20-60%	IDENTICAL
Test Range	20-600mg/dL(1.2-33.3mmol/L)	IDENTICAL
Operating Temp.	10-45°C (50-113°F)	64-90°F
Storage Temp.	35-89°F	IDENTICAL
Memory	500 tests	IDENTICAL
Display	LCD displays	IDENTICAL
Power Supply	CR 2032 Type	Four 1.5V AA Alkaline batteries
Size	4.7 × 9.5 × 1.75 (mm)	6.72 × 13.3 × 2.85 (cm)
Calibration	No-code	IDENTICAL

Substantial Equivalence Discussion

Similarities

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. Intended Use
Principle of operation
Test procedures
. Sample type
Sample volume
. Various specifications

Both the predicate and the subject device have the similar intended use, principle of operation, sample type, sample volume and various specifications.

Differences

Size of Meter .
. Power Source
. Operating Temp.

There are differences in size of meter and batter type between the two devices. We performed various clinical and bench tests and the test results supported that differences the subject device is substantially equivalent to the predicate devices.

7. DISCUSSION OF NON-CLINICAL AND CLINICAL TESTS PERFORMED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE ARE AS FOLLOWS:

There are a number of differences between the subject devices and the predicate devices as presented in the table above, however, the non-clinical-studies provided in this submission demonstrated that the differences do not raise a question of safety and effectiveness. Based on the information provided, we conclude that the subject device is substantially equivalent to the predicate device.

8. CONCLUSION:

Based on documentation supplied with this submission, the conclusions drawn from the non-clinical studies demonstrate that the subject devices are substantially equivalent to the predicate devices.

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.