LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.

K130295 · Infopia Co, Ltd. · NBW · Jun 21, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130295
• Device Name: LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.
• Applicant: Infopia Co, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jun 21, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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® 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. 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.

Device Story

System comprises meter, test strips, and control solutions; measures TC, HDL-C, TG, and glucose in capillary whole blood. Used in home (patient self-use) or professional healthcare settings (physician/nurse/technician). Input: capillary blood sample on test strip. Processing: electrochemical measurement of analytes; calculates LDL-C if TG ≤ 350 mg/dL. Output: quantitative concentration values displayed on meter; data transfer to PC/printer. Benefits: aids management of lipid disorders and diabetes. Professional version requires auto-disabling lancing device. Disinfection validated for multi-patient use.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed performance, functionality, and reliability against pre-determined pass/fail criteria. Disinfection study validated CaviWipes (EPA 46781-8) for meter and lancing device, demonstrating no performance degradation after 10,980 cycles (simulated 3 years of use).

Technological Characteristics

In vitro diagnostic meter for lipid/glucose measurement. Features include test strips, check strips, and control solutions. Materials include modified control solution bottles and redesigned strip covers/capillary rods. Connectivity includes PC data transfer. Software includes error messaging and temperature unit selection. Sterilization/disinfection validated for multi-patient use via CaviWipes (EPA Reg. No. 46781-8).

Indications for Use

Indicated for the quantitative measurement of lipids and glucose in blood. Intended for either single-patient use (LipidPro System) or multiple-patient use (LipidPro Professional System).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• LipidPro™ System (K090405)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE
RE: DOCUMENT NUMBER k130295

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: LipidPro® Lipid Profile and Glucose Measuring System (k090405).

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:

- Name change from LipidPro® Lipid Profile and Glucose Measuring System to LipidPro® Lipid Profile and Glucose Measuring System (for single patient use only) and LipidPro® Professional Lipid Profile and Glucose Measuring System (for multiple patients use), in order to distinguish the two separate systems.
- adding strip error message for all different lipid test strips
- adding a check strip for use with the LipidPro® Lipid Profile tests
- changing the button utilized to enter memory mode
- modifying the design of the strip cover (for all five test strips) and the capillary rod for use with the Lipid Profile tests only
- changing the raw material of all control solution bottles, including: total cholesterol (TC); high-density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose control solution
- renaming all control solutions (Total Cholesterol Control Solution, HDL Cholesterol Control Solution, Triglyceride Control Solution, and Glucose Control Solution) from low, medium, and high to Level 1, 2, and 3
- The volume of the control solutions has changed from 1 mL per bottle to 3 mL per bottle
- adding foil pouch package in addition to vial package for all the test strips
- adding a print option and printing/ data transfer to PC error message
- adding an option to select temperature unit (Fahrenheit v.s. Celsius).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

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i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

These devices are intended for either single-patient use only (LipidPro System) or for multiple-patient use (LipidPro Professional System). Disinfection efficacy studies were performed in k103021 on materials comprising the meter and lancing device by an outside commercial testing laboratory demonstrating complete inactivation of live hepatitis B virus with CaviWipes Disinfecting Towelettes (EPA Reg. No. 46781-8). Robustness studies were also performed by the sponsor demonstrating that there was no change in performance or external materials for each of the meters after 10,950 cleaning and disinfection cycles and after 1,098 cleaning and disinfection cycles for the lancing device (for use only with the single-patient use system) designed to simulate 3 years of use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.