(135 days)
Not Found
No
The summary describes a standard in vitro diagnostic device for measuring lipids and glucose in blood. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The device appears to rely on established biochemical measurement principles.
No.
A therapeutic device is one that treats a disease or condition. This device is an in vitro diagnostic device used to measure lipids and glucose, which aids in the diagnosis and management of conditions but does not provide therapy.
Yes
The text explicitly states that the measurements obtained from the various test strips (Total Cholesterol, HDL-cholesterol, Triglyceride, and Lipid Profile) "are used in the diagnosis and treatment of disorders." This directly indicates a diagnostic purpose for the device.
No
The device description explicitly states that the system consists of a meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states the following in the "Intended Use / Indications for Use" section:
- "The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only)."
- "The LipidPro® Professional Lipid Profile and Glucose Measuring System is intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only)."
- "LipidPro® Control Solutions are intended for use in home... and they are for testing outside the body (in vitro diagnostic use only)."
- "The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings... and they are for testing outside the body (in vitro diagnostic use only)."
The term "in vitro diagnostic use only" is a clear indicator that the device is an IVD. IVD devices are intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device measures substances (cholesterol, triglycerides, and glucose) in capillary whole blood, which is a specimen derived from the human body, and the results are used in the diagnosis and treatment of various conditions.
N/A
Intended Use / Indications for Use
- LipidPro® Lipid Profile and Glucose Measuring System: The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The LipidPro® Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The LipidPro® Lipid Profile and Glucose Measuring System is intended to be used by a single patient and should not be shared. The LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, Lipid Profile Test Strip, and LividPro® Glucose Test Strip are for use with the LipidPro® Lipid Profile and Glucose Meter. The LipidPro® Total Cholesterol Test Strip and the LipidPro® HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Total Cholesterol Test Strip and LipidPro® HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole bloodandthe obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and 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. The LipidPro® Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time. The LipidPro® Glucose Test Strip 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, caff and/or thigh by diabetic patients as an aid in the management of diabetes, Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/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, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Lipid Profile and Glucose Measuring 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 use in home.
- LipidPro® Professional Lipid Profile and Glucose Measuring System: The LipidPro® Professional Lipid Profile and Glucose Measuring Systemis intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Lipid Profile and Glucose Measuring 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. The LipidPro® Professional Lipid Profile and Glucose Measuring System should only be used with auto-disabling, single-use lancing device. The LipidPro® Professional Total Cholesterol Test Strip, LipidPro® Professional HDL-cholesterol Test Strip, LipidPro® Professional Triglyceride Test Strip, LipidPro® Professional Lipid Profile Test Strip, and LipidPro® Professional Glucose Test Strip are for use with the LipidPro® Professional Lipid Profile and Glucose Meter. The LipidPro® Professional Total Cholesterol Test strip and the LipidPro® Professional HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Professional Total Cholesterol Test strip and ' LipidPro® Professional HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Professional Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and 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 LDLcholesterol are not reported. The LipidPro® Professional Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time. The LipidPro® Professional Glucose Test Strip 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 as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly. The LipidPro® Professional Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Professional Lipid Profile and Glucose Measuring 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). The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings.
Product codes (comma separated list FDA assigned to the subject device)
CHH, LBR, JGY, NBW, CGA, JJX
Device Description
The LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System consist of a meter, test strips, and control solutions. It combines measuring systems for total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and a blood glucose monitoring system into one convenient device. The components are a meter, five types of test strips, and four types of control solutions. There are five types of the test strips which are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), a lipid profile (which combines TC, HDL-C, and TG tests) and glucose test respectively. There are also four types of the control solutions for total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose test respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
- LipidPro® Lipid Profile and Glucose Measuring System: self testing (in home)
- LipidPro® Professional Lipid Profile and Glucose Measuring System: multiple patient use in professional health care settings
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)
Clinical & Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the LipidPro® / LioidPro® Professional Lipid Profile and Glucose Measuring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been validated demonstrating complete inactivation of live virus of use with the meter and the reusable lancing device. There was also no change in performance or in the external materials of the meter and the lancing device after 10,980 cleaning/disinfection cycles designed to simulate 3 years of device use.
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
130295
Infopia Co., Ltd.
Special 510(k) for LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System
JUN 2 1 2013
510(k) Summary
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:_06/12/2013
- Submitter
| Submitter | |
|---|---|
| Name | |
| Address | Infopia Co.,Ltd. |
| 891 Hogye-dong, Dongan-Gu, Anyang, Kyunggi, | |
| 431-080, Korea | |
| Phone | |
| Fax | Phone: +82-31-460-0300 |
| Fax: +82-31-460-0401 |
- Submission Correspondent
LK Consulting Group USA, Inc. 1515 E Katella Ave. Unit 2115, Anaheim, CA 92805 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
| • Trade Name: | LipidPro® Lipid Profile and Glucose Measuring System
LipidPro® Professional Lipid Profile and Glucose Measuring System |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Classification: | Total cholesterol test system (21 CFR Part 862.1175)
Lipoprotein test system (21 CFR Part 862.1475)
Triglyceride test system (21 CFR Part 862.1705)
Glucose test system (21 CFR Part 862.1345)
Quality control material (21 CFR Part 862.1660) |
| • Product Code: | CHH, LBR, JGY, NBW. CGA, JJX |
4. Predicate Device:
(K090405) LipidPro™ System, LipidPro™ Total Cholesterol Control Solution, LipidPro™ HDL Cholesterol Control Solution, LipidPro™ Triglyceride Control Solution, LipidPro™ Glycose Control Solution
-
- Description:
The LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System consist
- Description:
510(k) Submission
1
of a meter, test strips, and control solutions. It combines measuring systems for total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and a blood glucose monitoring system into one convenient device.
The components are a meter, five types of test strips, and four types of control solutions. There are five types of the test strips which are for total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), a lipid profile (which combines TC, HDL-C, and TG tests) and glucose test respectively. There are also four types of the control solutions for total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose test respectively.
- Indications for use:
· LipidPro® Lipid Profile and Glucose Measuring System
The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The LipidPro® Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The Lipid Profile and Glucose Measuring System is intended to be used by a single patient and should not be shared.
The LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, Lipid Profile Test Strip, and LividPro® Glucose Test Strip are for use with the LipidPro® Lipid Profile and Glucose Meter.
The LipidPro® Total Cholesterol Test Strip and the LipidPro® HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Total Cholesterol Test Strip and LipidPro® HDLcholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole bloodandthe obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and 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. The LipidPro® Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Glucose Test Strip 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, caff and/or thigh by diabetic patients as an aid in the management of diabetes, Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/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, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Lipid Profile and Glucose Measuring 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 use in home.
510(k) Submission
2
· LipidPro® Professional Lipid Profile and Glucose Measuring System
The LipidPro® Professional Lipid Profile and Glucose Measuring Systemis intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Lipid Profile and Glucose Measuring 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. The LipidPro® Professional Lipid Profile and Glucose Measuring System should only be used with auto-disabling, single-use lancing device.
The LipidPro® Professional Total Cholesterol Test Strip, LipidPro® Professional HDL-cholesterol Test Strip, LipidPro® Professional Triglyceride Test Strip, LipidPro® Professional Lipid Profile Test Strip, and LipidPro® Professional Glucose Test Strip are for use with the LipidPro® Professional Lipid Profile and Glucose Meter.
The LipidPro® Professional Total Cholesterol Test strip and the LipidPro® Professional HDLcholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Professional Total Cholesterol Test strip and ' LipidPro® Professional HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Professional Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and 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 LDLcholesterol are not reported.
The LipidPro® Professional Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Professional Glucose Test Strip 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 as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
The LipidPro® Professional Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Professional Lipid Profile and Glucose Measuring 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). The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings.
- Comparison to the Cleared Device
The modifications to the cleared device are as follows: adding strip error message, strip code error message and a check strip, changing the button utilized to enter memory mode, modifying the design of the strip cover(all five strips) and the capillary rod, changing the raw material of control solution bottles, adding foil pouch package option for the LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, and LipidPro® Lipid Profile Test Strip), adding printing option and printing / data transfer to PC
510(k) Submission
3
error message and display temperature unit change.
Other than these modifications, the modified system has the following similarities to the cleared device:
- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same materials,
- · · adopts the same use environment and calibration method, and has the same shelf life.
- Performance Data
Clinical & Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics of the LipidPro® / LioidPro® Professional Lipid Profile and Glucose Measuring System. The device passed all of the tests based on pre-determined Pass/Fail criteria.
Disinfection Study: Disinfectant CaviWipes with the EPA registration number of 46781-8 has been
validated demonstrating complete inactivation of live virus of use with the meter and the reusable lancing device. There was also no change in performance or in the external materials of the meter and the lancing device after 10,980 cleaning/disinfection cycles designed to simulate 3 years of device use.
- Conclusion
The conclusion drawn from the clinical and nonclinical tests is that the LipidPro® / LipidPro® Professional Lipid Profile and Glucose Measuring System is as safe, as effective and performs as well as the legally marketed predicate device, LipidPro™ System (K090405).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized abstract symbol, possibly representing a human form or a stylized eagle, with three flowing lines beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 21, 2013
Infopia Co., Ltd. C/O Priscilla Chung LK Consulting Group 1515 E Katella Ave., Unit 2115 ANAHEIM CA 92805
Re: K130295
Trade/Device Name: LipidPro® Lipid Profile and Glucose Measuring System LipidPro® Professional Lipid Profile and Glucose Measuring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, CHH, JGY, JJX, LBR Dated: May 17, 2013 Received: May 22, 2013
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. 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 Part 801); 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
5
Page 2-Ms. Chung
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note to regulations 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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -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
6
510(k) Number: K130295
Device Name: LipidPro® Lipid Profile and Glucose Measuring System
Indication for use:
The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The LipidPro® Lipid Profile and Glucose Measuring System is intended to be used by a single patient and should not be shared.
The LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, LipidPro® Lipid Profile Test Strip, and LipidPro® Glucose Test Strip are with the LipidPro® Lipid Profile and Glucose Meter.
The LipidPro® Total Cholesterol Test Strip and the LipidPro® HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders. The LipidPro® Total Cholesterol Test Strip and LipidPro® HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole bloodandthe obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and 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.
The LipidPro® Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Glucose Test Strip 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 as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steadystate times when glucose is not changing rapidly.
LipidPro@ Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the Lipid Profile and Glucose Measuring 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 use in home.
Prescription Use (Part 21CFR 801Subpart D) AND/OR
Over-The-Counter Use (Part 21CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OFNEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 510(k) K130295
Page 1 of 2
7
510(k) Number: K130295
Device Name: LipidPro@ Professional Lipid Profile and Glucose Measuring System
Indication for use:
The LipidPro® Professional Lipid Profile and Glucose Measuring Systemis intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Lipid Profile and Glucose Measuring 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. The LipidPro® Professional Lipid Profile and Glucose Measuring System should only be used with autodisabling, single-use lancing device.
The LipidPro@ Professional Total Cholesterol Test Strip, LipidPro® Professional HDL-cholesterol Test Strip, LipidPro® Professional Triglyceride Test Strip, LipidPro® Professional Lipid Profile Test Strip, and LipidPro® Professional Glucose Test Strip are for use with the LipidPro® Professional Lipid Profile and Glucose Meter.
The LipidPro® Professional Total Cholesterol Test strip and the LipidPro® Professional Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders.The LipidPro® Professional Total Cholesterol Test strip and LipidPro® Professional HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Professional Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and 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.
The LipidPro® Professional Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Professional Glucose Test Strip 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 as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for necnatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
The LipidPro® Professional Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro@ Professional Lipid Profile and Glucose Measuring 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).The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings.
Prescription Use (Part 21CFR 801 Subpart D)
Over-The-Counter Use
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OFNEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
AND/OR
Yung W. Chan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health 210(K) K130292
Page 2 of 2