LipidPro™ system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro™ system which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood.

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, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDLcholesterol values are reported only when triglycerides are < 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported.

Glucose measurement is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.

LipidPro™ Total Cholesterol control solution, HDL-cholesterol control solution, Triglyceride control solution, and Glucose control solution are used to test the precision of the LipidPro™ system and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only.) LipidPro™ control solutions are intended for in home and health care professionals use.

Device Description

The LipidPro " system is a device which combines measuring systems for total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol and triglyceride, and a blood glucose monitoring system into one convenient device. The glucose monitoring system function of the device utilizes Infopia's Evolution™ monitoring system cleared under K072369.

The LipidPro 10 system consists of a meter, five types of test strips, and four types of control solutions. The five types of the test strips are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG),a lipid profile (which combines TC, HDL-C, TG tests) and glucose test respectively. The four types of the control solutions are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose test respectively.

LDL value is calculated from TC, HDL-C, and TG values using the following numerical formula. When TG is over 350 mg/dL, LDL is not calculated.

LDL=TC-HDL-(TG/5)

LipidPro " glucose test system is identical to the EVOLUTION™ glucose test system cleared under K072369. LipidPro™ glucose test strip is the same as the EVOLUTION™ glucose test strip except the cover printing design. Their size and components are the same. LipidPro™ glucose test meter is identical to the EVOLUTION " glucose test meter except the external design and having a lipid profile (TC/TG/HDL-C) test part on the other side of the meter. This does not affect to the safety and effectiveness for glucose test and data.

The test range of LipidPro TM system is 100-400mg/dL for total cholesterol, 25-80 mg/dL for HDLcholesterol. 70-600 mg/dL for Triglyceride and 20-600mg/dL for glucose. LDL cholesterol should be estimated from measurement of total cholesterol, HDL cholesterol and triglycerides.

LipidPro™ system has two kinds of test principle according to test items: one for glucose and the other for a lipid profile (TC, HDL-C, and TG).

Lipid profile test results are based on reading reflection density. When the blood is applied, the color changes in test area through an enzyme reaction. The meter records this change in color and converts the measurement signal to the displayed result using the data previously entered via the code. The deeper the color is, the higher the lipid level is.

Glucose in the blood sample will react to the electrodes in the glucose test strip, generating an electrical current that will stimulate a chemical reaction is measured by LipidPro™ meter and displayed as your blood glucose result.

AI/ML Overview

The provided 510(k) summary for the Infopia LipidPro™ system contains limited information regarding specific acceptance criteria and the detailed study that proves the device meets these criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than rigorous performance metric reporting against predefined benchmarks.

However, based on the available text, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a structured table. Instead, it refers to "pass or fail criteria were based on the specifications cleared for the predicate device" and concludes with a qualitative statement of "substantial equivalence."

However, the "Comparison of Technological Characteristics with Predicate" section provides some implicit performance ranges that can be considered as the device's reported performance, and by extension, the acceptance criteria would be that the device operates within or acceptably close to these ranges as compared to the predicate.

Measurement / Characteristic	LipidPro™ Lipid Measuring System Reported Performance	Predicate Device (PTS PANELS Lipid Panel Test Strips) Performance	(Implicit) Acceptance Criteria
Total Cholesterol (TC)	Test range: 100-400 mg/dL	Test range: 100-400 mg/dL	Performance within 100-400 mg/dL range and substantially equivalent to predicate device accuracy.
HDL-Cholesterol (HDL-C)	Test range: 25-80 mg/dL	Test range: 25-85 mg/dL	Performance within 25-80 mg/dL range and substantially equivalent to predicate device accuracy.
Triglyceride (TG)	Test range: 70-600 mg/dL	Test range: 50-500 mg/dL	Performance within 70-600 mg/dL range and substantially equivalent to predicate device accuracy.
Glucose	Test range: 20-600 mg/dL	Test range: 20-600 mg/dL	Performance within 20-600 mg/dL range and substantially equivalent to predicate device accuracy.
Hematocrit range (Lipid)	30 ~55%	TC: 30~~50%, HDL-C: 30~~45%, TG: 15~55%	Operates within relevant hematocrit ranges, demonstrating substantial equivalence.
Hematocrit range (Glucose)	30 ~55%	20~60%	Operates within relevant hematocrit ranges, demonstrating substantial equivalence.
Sample volume (Lipid)	5 µl	15 µl	Device performs with its stated sample volume, demonstrating at least equivalent performance to predicate's larger volume.
Sample volume (Glucose)	0.3 µl	0.3 µl	Device performs with its stated sample volume, demonstrating substantial equivalence.
Test time (Lipid)	1-2 minutes	1-2 minutes	Performance within 1-2 minutes.
Test time (Glucose)	3 seconds	3 seconds	Performance within 3 seconds.

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

The document states: "The clinical performance evaluation using the LipidPro™ system was conducted for the purpose of validating the TC, HDL-C, LDL-C, TG, and Glucose measuring accuracy." However, it does not specify the sample size used for this clinical test set, nor does it provide information on the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The document refers to "ground truth" implicitly as the reference measurements against which the device's accuracy was compared, but it does not detail how this ground truth was established or the experts involved.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not performed or reported. The device is an in vitro diagnostic (IVD) measurement system, not an imaging or diagnostic aid that typically involves human reader interpretation. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was performed. The "clinical performance evaluation" assessed the LipidPro™ system's measuring accuracy for TC, HDL-C, LDL-C, TG, and Glucose. This evaluation measures the device's performance directly, independent of human interpretation or intervention beyond sample application. The conclusion states the device "performs as well as the legally marketed predicate device," indicating a standalone assessment.

7. Type of Ground Truth Used

The document does not explicitly state the specific "type" of ground truth used (e.g., pathology, outcomes data). However, for an in vitro diagnostic such as this, the ground truth would typically be established by high-precision laboratory reference methods (e.g., enzymatic assays performed on a clinical chemistry analyzer) for each analyte (Total Cholesterol, HDL-C, Triglyceride, Glucose) on the same blood samples. The "measuring accuracy" assessment implies a comparison against such reference methods.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. For this type of IVD device, the development and calibration of the device's algorithms or enzymatic reactions would typically be done using internal development data. The reported "clinical performance evaluation" is usually considered the validation or test set.

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

As no separate training set size is mentioned, the method for establishing its ground truth is also not described. For the internal development/calibration, the ground truth would be established through laboratory reference methods on well-characterized samples.

Summary

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ﻬﺮ ﺑ

Infopia Co., Ltd.

510(K) Summary (K090405)

DEC - 1 2009

This summary of 510(k) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

1. Application date: 02/17/09

2. Submitter Information

Infopia Co.,Ltd.

#1603, Dongil Technotown A Bldg., 889-3, Kwanyang2-Dong, Dongan - Gu Anyang, Kyunggi 431-716, Korea Phone: +82-31-423-6170 Fax: +82-31-423-6171

ﺪ

3. U.S Agent/Contact Person

13340 E Firestone Blvd. Suite J, Santa Fe Springs, CA 90670 Priscilla Juhee Chung Fax: 562-404-2757 Email: agent.fda@gmail.com Phone: 562-404-8466

Trade name: LipidPro™ system, LipidPro™ Total cholesterol (TC) control solution, LipidPro™ High density lipoprotein cholesterol (HDL-C) control solution, LipidPro™ Triglyceride (TG) control solution and LipidPro™ Glucose control solution

5. Classification name:

Total cholesterol test system (21 CFR Part 862.1175, CHH)

Lipoprotein test system (21 CFR Part 862.1475, LBR)

Triglyceride test system (21 CFR Part 862.1705, JGY)

Glucose test system (21 CFR Part 862.1345, NBW, CGA)

Quality control material (assayed and unassayed) (21 CFR Part 862.1660, JJX)

6. Predicate

Predicate for the Lipid profile test system ・

PTS PANELS Lipid Panel Test Strips (K023558) / Polymer Technology Systems, Inc.

Predicate for the glucose test system -
Evolution™ Blood Glucose Test System (K072369) / HMD Biomedical LLC.

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Predicate for the control solution

PTS Panels Multi-Chemistry Controls (K022401) / Polymer Technology Systems, Inc.

7. Device Description

LDL value is calculated from TC, HDL-C, and TG values using the following numerical formula. When TG is over 350 mg/dL, LDL is not calculated.

LDL=TC-HDL-(TG/5)

LipidPro™ system has two kinds of test principle according to test items: one for glucose and the other for a lipid profile (TC, HDL-C, and TG).

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8. Intended Use

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, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are < 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported.

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9. Comparison of Technological Characteristics with Predicate

The LipidPro™ system has the same technological characteristics as the current legally marketed predicate device, PTS PANELS Lipid Panel Test Strips (K023558), Evolution™ Blood Glucose Test System (K072369) and PTS Panels Multi-Chemistry Controls (K022401).

Similarities and Differences of the Lipid profile measuring system
Item	LipidPro™ lipid measuring system	PTS PANELS Lipid Panel Test Strips (K023558)
Detection method	Spectrophotometry	Spectrophotometry
Enzyme	TC: Cholesterol esterase,Cholesterol oxidase, PeroxidaseHDL-C: Cholesterol esterase,Cholesterol oxidase, PeroxidaseTG: Lipase lipoprotein,Glycerol kinase, Glycerol-3-Phosphate Oxidase, Peroxidase	TC: Cholesterol esterase,Cholesterol oxidase, PeroxidaseHDL-C: Cholesterol esterase,Cholesterol oxidase, PeroxidaseTG: Lipase lipoprotein, Glycerolkinase, Glycerol-3-PhosphateOxidase, Peroxidase
Color Fixatives	TC, HDL-C, TG:4-aminoantipyrineSubstituted aniline derivatives	TC, HDL-C:4-aminoantipyrineSubstituted aniline derivativesTG:4-aminoantipyrineN,N-disubstituted aniline
Coding	Auto-coding by the RFID tag	MEMO Chip
Sample type	Capillary whole blood	Capillary whole bloodVenous whole blood
Humidity range	10~90%	20 ~ 80%
Power supply	2 AAA 1.5 Volt alkaline	2 AAA 1.5 Volt alkaline
Battery lifetime	1000tests	300tests
Test range	TC : 100-400 mg/dLHDL-C: 25-80 mg/dLTG: 70-600 mg/dL	TC : 100-400 mg/dLHDL-C: 25-85 mg/dLTG: 50-500 mg/dL
Hematocrit range	TC, HDL-C, TG:30 ~55%	TC: 30~~50%HDL-C: 30~~45%TG: 15~55%
Test time	1-2 minutes	1-2 minutes
Sample volume	5 μl	15 μl
Temperature range	18-30°C (64~86°F)	18-35°C (64.4-95°F)
Similarities and Differences of the Lipid profile measuring system
Item	LipidPro™ lipid measuring system	PTS PANELS Lipid Panel TestStrips (K023558)
Size L x W x H (cm)	10.9 X 6.04 X 2.29	13.97 X 7.62 X 2.54
Weight	77.5 g	121.9 g

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・

Similarities and Differences of the Blood Glucose System
Item	LipidPro™ glucose measuringsystem	Evolution glucose system(K072369)
Detection method	Amperometry	Amperometry
Enzyme	Glucose Oxidase	Glucose Oxidase
Mediator	Hexaammineruthenium(III)Chloride	Hexaammineruthenium(III)Chloride
Electrode	Carbon electrode	Carbon electrode
Coding	Auto-coding by the color bar	Auto-coding by the color bar
Sample type	Capillary whole blood	Capillary whole blood
Humidity range	10 ~ 90%	20 ~ 80%
Power supply	2 AAA 1.5 Volt alkaline	3V Li battery (CR2032×2)
Battery lifetime	1000 tests	1 years
Test range	20 ~ 600 mg/dL	20~600 mg/dL
Hematocrit range	30 ~55%	20~60%
Test time	3 seconds	3 seconds
Sample volume	0.3 uL	0.3 uL
Temperature range	18-30°C (64~86°F)	10~~40°C(50~~104°F)
Memory capability	200 tests	7, 14, 21-day average and 365 testsin the memory
Size L x W x H (cm)	10.9 X 6.04 X 2.29	7.6 X 5.6 X 1.8
Weight	77.5 g	45g

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Similarities and Differences of the control solution
Item	LipidPro™ Control Solution	PTS panels multi-chemistry ControlSolution (K022401)
Indication for use	LipidPro™ Total Cholesterolcontrol solution, HDL-cholesterol control solution,Triglyceride control solution,and Glucose control solution areused to test the precision of theLipidPro™ system and to detectsystematic analytic deviationsthat may arise from reagent oranalytical variation and they arefor testing outside the body (invitro diagnostic use only.)	The PTS PANELS Multi-ChemistryControls are intended for use on theBioScanner2000 and CardioChekbrand instruments to estimateprecision and to detect systematicanalytical deviations that may arisefrom reagent or analyticalinstrument variation and areintended for use by healthcareprofessionals in both physicians'offices and in acute andconvalescent care facility bedsidetesting as well as consumers athome.
Analyte	GlucoseTC: Total CholesterolHDL-C: HDL-CholesterolTG: Triglyceride	Cholesterol, Triglyceride, Glucose,and Ketones
Number of levels	TC: 2 Levels(Normal, Abnormal)HDL-C: 2 Levels(Normal, Abnormal)TG: 2 Levels(Normal, Abnormal)	2 Levels (Level 1, Level 2)
Container	Bottle	Bottle
Color	Clear	Clear
Temperature range	8~~30℃(46~~86°F)	20~~30℃(68~~86°F)
Fill volume	1.0mL	1.5mL
Matrix	TC:Cholesterol, insert ingredientsHDL-C:Cholesterol, insert ingredientsTG:Triglyceride, insert ingredients	Glucose, Glycerol, Cholesterol,DL-β-Hydroxybutyric Acid,MIT(methyl isothazoldone)and insert ingredients
Target range	The expected range is printed on the Control Solution Range Card	The expected range is printed on theQuality Control Solution RangeCard

10. Performance Data

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Clinical: The clinical performance evaluation using the LipidPro™ system was conducted for the purpose of validating the TC, HDL-C, LDL-C, TG, and Glucose measuring accuracy. Test results showed substantial equivalence.

Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the LipidPro™ system with respect to the predicate device. Pass or fail criteria were based on the specifications cleared for the predicate device and results showed substantial equivalence.

11. Conclusion

The conclusion drawn from the clinical and the non clinical tests is that the LipidPro™ system is as safe, as effective, and performs as well as the legally marketed predicate device, the PTS PANELS™

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Image /page/7/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 figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Infopia Co., Ltd. c/o Ms. Priscilla Chung Krodent DBA TMS 13340 E. Firestone Blvd., Suite J Santa Fe Springs, CA 90670

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

DEC - 1 2009

Re: Re: K090405

Trade Name: LipidPro™ system (ILM-0001A), LipidPro™ Total cholestero1 (TC) control solution, LipidPro™ High density lipoprotein cholesterol (HDL-C) control solution, LipidPro™ Triglyceride (TG) control solution and LipidPro™ glucose control solution

Regulation Number: 21 CFR §862.1345

Regulation Name: Glucose Test System.

Regulatory Class: Class II

Product Codes: CGA, NBW, JGY, CHH, LBR, JJX

Dated: November 18, 2009

Received: November 19, 2009

Dear Ms. 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.

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).

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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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K090405

Device Name: LipidPro™ system (ILM-0001A), LipidPro™ Total cholesterol (TC) control solution, LipidPro™ High density lipoprotein cholesterol (HDL-C) control solution, LipidPro™ Triglyceride (TG) control solution and LipidPro™ Glucose control solution

Indication For Use:

Prescription Use (21 CFR Part 801 Subpart D) And/Or

· Over the Counter Use _ X . (21: CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K090405

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Indication for Use

510(k) Number (if known): K090405

Device Name: LipidPro™ system (ILM-0001A), LipidPro™ Total cholesterol (TC) control solution, LipidPro " High density lipoprotein cholesterol (HDL-C) control solution, LipidPro™ Triglyceride (TG) control solution and LipidPro™ Glucose control solution

Indication For Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X . (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benaan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K090405

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.