Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System

K163406 · ACON Laboratories, Inc. · CHH · Jul 11, 2017 · Clinical Chemistry

Device Facts

Record IDK163406
Device NameMission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
ApplicantACON Laboratories, Inc.
Product CodeCHH · Clinical Chemistry
Decision DateJul 11, 2017
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 862.1175
Device ClassClass 1
AttributesPediatric

Intended Use

The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides 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. Use this product at the frequency your doctor recommends for testing Total Cholesterol and Triglycerides. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL.

Device Story

Portable reflectance photometer system; measures Total Cholesterol, HDL, and Triglycerides in capillary or venous whole blood. User applies blood to dry-phase test cartridge; meter analyzes light intensity reflected from reagent area. Includes code chip for automatic calibration. Professional version (Pro) supports multiple patient use in healthcare settings; home version for single-patient use. Provides quantitative lipid results; calculates estimated LDL when Triglycerides <400 mg/dL. Used by patients or healthcare professionals to monitor lipid metabolism disorders; results inform clinical management of atherosclerosis, diabetes, and metabolic conditions.

Clinical Evidence

Clinical study of 369 patients at three point-of-care sites. Compared layperson and professional performance using capillary and venous blood against an FDA-cleared reference method. Results showed high correlation (R² 0.9768–0.9948) across all analytes. Bias at medical decision points was minimal (range -1.8% to 1.9%).

Technological Characteristics

Reflectance photometer; 35 μL sample volume; 4 AAA batteries or AC adapter; USB connectivity for printer/power. Test cartridges use enzymatic reagents (cholesterol esterase/oxidase, lipoprotein lipase, glycerol kinase). Dimensions: 137mm x 79mm x 26mm. Weight: 145g. Automatic shut-off after 5 minutes.

Indications for Use

Indicated for quantitative determination of Total Cholesterol, HDL, and Triglycerides in human capillary whole blood (fingertip) for home use, and additionally lithium heparin venous whole blood for professional use. Used for diagnosis/treatment of lipid/lipoprotein metabolism disorders, atherosclerosis, diabetes mellitus, nephrosis, liver obstruction, and endocrine disorders. Contraindicated for neonates, critically ill patients, and those with hematocrit outside 30-50% range.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines representing movement or progress. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 11, 2017 ## ACON LABORATORIES INC. QIYI XIE, SR. STAFF CLINICAL/REGULATORY AFFAIRS 10125 MESA RIM ROAD SAN DIEGO, CA 92121 Re: K163406 Trade/Device Name: Mission Cholesterol Monitoring System Mission Cholesterol Pro Monitoring System Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: I, meets the limitation to the exemption 21 CFR 862.9(c)(4) Product Code: CHH. JGY. LBR Dated: April 10, 2017 Received: April 12, 2017 Dear Dr. Oiyi Xie: 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2-Dr. Qiyi Xie 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/Resourcesfor You/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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) k163406 Device Name Mission® Cholesterol Monitoring System #### Indications for Use (Describe) The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Trighcerides measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. Use this product at the frequency your doctor recommends for testing Total Cholesterol, and Triglycerides. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL. | Type of Use (Select one or both, as applicable) | | | | |------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------| | | <table border="0"><tr><td><span></span>Prescription Use (Part 21 CFR 801 Subpart D)</td></tr><tr><td><span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | | | | | <span></span> 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### Indications for Use 510(k) Number (if known) k163406 Device Name Mission® Cholesterol Pro Monitoring System #### Indications for Use (Describe) The Mission® Cholesterol Pro Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter, Mission Cholesterol Pro Test Cartridges, Mission Cholesterol Optical Verifier, and Mission Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides measurements are used in the diagnosis and treatments with diabetes mellitus. nephrosis, liver obstruction, and other diseases involving lipid metabolism or various endocrine disorders. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | |----------------------------------------------|---------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> | 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 infornation 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 "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {4}------------------------------------------------ #### 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The Assigned 510(k) number is k163406 #### Submitter's Identification: ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121 Tel.: 858-875-8019 Fax: 858-875-8011 Date Prepared: June 27, 2017 #### Contact Person: Qiyi Xie Senior Staff, Clinical & Regulatory Affairs Email: qxie@aconlabs.com ### Proprietary Name of the Device: Professional use: Mission® Cholesterol Pro Monitoring System Mission® Cholesterol Pro Test Cartridge Home use: Mission® Cholesterol Monitoring System Mission® Cholesterol Test Cartridge #### Common Name: Cholesterol (total) Test System, Triglyceride Test System, Lipoprotein Test System ### Regulation : 21 CFR 862.1175, 862.1705, 862.1475 ### Classification: Class I, meet the limitation of exemption per 21 CFR 862.9(c)(4) {5}------------------------------------------------ # Predicate Device: Cardiochek Plus and Home Test System 510(k) Number: K140068 Polymer Technology Systems, Inc. 7736 Zionsville Rd Indianapolis, IN 46268 ## Device Name: # 1) Mission® Cholesterol Monitoring System (home use) | Proprietary Name | Regulation -<br>Classification | Product Code | Description | |-------------------------------------------|--------------------------------|--------------|------------------------------------| | Mission® Cholesterol<br>Monitoring System | 21 CFR 862.1175 –<br>Class I | CHH | Cholesterol (total) Test<br>System | | Mission® Cholesterol<br>Meter | 21 CFR 862.1705 –<br>Class I | JGY | Triglyceride Test System | | Mission® Cholesterol<br>Test Cartridges | 21 CFR 862.1475 -<br>Class I | LBR | Lipoprotein Test System | ## 2) Mission® Cholesterol Pro monitoring system (professional use): | Proprietary Name | Regulation -<br>Classification | Product Code | Description | |--------------------------------------------------|--------------------------------|--------------|------------------------------------| | Mission® Cholesterol<br>Pro Monitoring<br>System | 21 CFR 862.1175 –<br>Class I | CHH | Cholesterol (total) Test<br>System | | Mission® Cholesterol<br>Pro Meter | 21 CFR 862.1705 –<br>Class I | JGY | Triglyceride Test System | | Mission® Cholesterol<br>Pro Test Cartridges | 21 CFR 862.1475 –<br>Class I | LBR | Lipoprotein Test System | {6}------------------------------------------------ ### Device Description: - 1) Over the Counter (home use): The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution and is intended to be used by a single person and should not be shared. The Mission Cholesterol Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary whole blood from the fingertip. The Mission Cholesterol Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis. - 2) Professional: The Mission Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter. Mission Cholesterol Pro Test Cartridges. Mission Cholesterol Pro Optical Verifier and Mission Cholesterol Pro Control Solution and is intended for professional use in healthcare settings for multiple patient uses. The Mission Cholesterol Pro Monitoring System is designed for the quantitative measurement of Total Cholesterol (CHOL), High Density Lipoprotein Cholesterol (HDL) and Triglycerides (TRIG) in capillary and venous human whole blood. The Mission Cholesterol Pro Meter is an in vitro diagnostic device consisting of a reflectance photometer that analyzes the intensity and color of light reflected from the reagent area of the test cartridge. This device measures analytes in blood once the blood is applied to dry phase test cartridges that are specifically designed for reflectance analysis. ### Test Cartridge: The Mission Cholesterol (Home use) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary whole blood from the fingertip. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter. {7}------------------------------------------------ The Mission Cholesterol Pro (Professional) Test Cartridge is a 3 in 1 Lipid Panel test device used to measure concentration of CHOL, HDL and TRIG in capillary and venous human whole blood. A code Chip automatically calibrates the meter with the code number of the cartridges when inserted into the meter. ### Control Solution: Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Control Solutions are used to estimate precision of meter readings for determination of total cholesterol (CHOL), high density lipoprotein cholesterol (HDL) and triglycerides (TRIG). #### Optical verifier: Both the Mission® Cholesterol (home use) Monitoring System's and the Mission® Cholesterol Pro Monitoring System's Optical Verifiers are used to verify that the meter functions properly by checking that the meter can detect a pre-calibrated value. ### Intended Use: #### 1) Over the Counter Use: The Mission® Cholesterol Monitoring System is intended for the quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip. The Mission Cholesterol Monitoring System is a portable system consisting of the Mission Cholesterol Meter, Mission Cholesterol Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended to be used by a single person and should not be shared. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. {8}------------------------------------------------ HDL (High Density Lipoprotein Cholesterol) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides 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. Use this product at the frequency your doctor recommends for testing Total Cholesterol and Triglycerides. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are <400 mg/dL. ### 2) Professional Use: The Mission® Cholesterol Pro Monitoring System is intended for the quantitative determination of Total Cholesterol, High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingertip and lithium heparin venous whole blood. The Mission® Cholesterol Pro Monitoring System is a portable system consisting of the Mission Cholesterol Pro Meter, Mission Cholesterol Pro Test Cartridges, Mission Cholesterol Optical Verifier and Mission Cholesterol Control Solution, and is intended for multiple patient use in professional healthcare settings. This system should only be used with single-use, auto- disabling lancing devices. This system is for in vitro diagnostic use only. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. HDL (High Density Lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Triglycerides 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. An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Meter and is reported only when Triglycerides are ≤400 mg/dL. {9}------------------------------------------------ ## Technological Characteristics: Specification of the Mission® Cholesterol Monitoring (Home use) and Mission® Cholesterol Pro Monitoring Meters: | Feature | Specifications | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Methodology | Reflectance Photometer | | Test Time | ≤ 2 min | | Measurement<br>Range | CHO: 100-400mg/dL (2.59-10.36 mmol/L,1mmol/l=38.66mg/dL )<br>HDL: 15-100 mg/dL (0.39-2.59 mmol/L, 1mmol/l=38.66mg/dL)<br>TRIG: 45-650 mg/dL (0.51-7.34 mmol/L, 1mmol/l=38.6mg/dL) | | Specimen | Whole blood | | Specimen Volume | 35 μL | | Power Source | 4 AAA batteries (1.5V)<br>AC Adapter (Mini USB, 5V dc, 50 mA) | | Battery Life | 85 hours or 1,000 tests | | Units of<br>Measurement | mg/dL | | Memory | 200 records | | Automatic Shut Off | 5 minutes after last use | | Meter Size | 137 mm × 79 mm × 26 mm (5.4" × 3.11” ×1.02") | | Display Size | 50 mm × 50 mm (1.97" ×1.97") | | Weight | 145g (without batteries) | | Meter Storage<br>Conditions | 0 - 50°C (32 -122°F); ≤ 90% RH | | Operating<br>Conditions | 15 - 40°C (59 -104°F); 20- 90% RH | | Meter Connectors | USB cable for Printer or Power (optional) | ## Special conditions for use statement(s): Over-the-counter: - Do not test samples other than fresh capillary whole blood obtained from the fingertip. ● - For single-patient use only. ● - Do not use on neonates. - Do not reuse; each Test Cartridge is for single use only. . {10}------------------------------------------------ - Users with low or high red blood cell counts (e.g. users with anemia or polycythemia) may have inaccurate results. - Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 30%. ● - Users with dehydration or peripheral vascular disease should avoid fingertip testing. ● - Do not use when humidity is higher than 90% and lower than 20%, as extremes in humidity mav . affect results. - Critically ill patients should not use this test. - Do not use test cartridge after the expiration date shown on the pouch. ● - High concentrations of uric acid (≥12 mg/dL) can lead to falsely low measurements for Total ● Cholesterol and HDL Cholesterol. - High concentrations of bilirubin (≥15 mg/dL) can lead to falsely low measurements for Total Cholesterol and HDL Cholesterol. ## Prescription use: - Do not use on neonates. ● - Do not reuse; each Test Cartridge is for single use only. - Users with low or high red blood cell counts (e.g. users with anemia or polycythemia) may have . inaccurate results. - Do not use when Hematocrit is outside the acceptable Hematocrit range for testing of 30% to 50%. - Users with dehydration or peripheral vascular disease should avoid fingertip testing. - . Do not use when humidity is higher than 90% and lower than 20%, as extremes in humidity may affect results. - . Critically ill patients should not use this test. - Do not use test cartridge after the expiration date shown on the pouch. - High concentrations of uric acid (>12 mg/dL) can lead to falsely low measurements for Total ● Cholesterol and HDL Cholesterol. - . High concentrations of bilirubin (≥15 mg/dL) can lead to falsely low measurements for Total Cholesterol and HDL Cholesterol. - Heparin is recommended anticoagulant for use with venous whole blood. Do not use other ● anticoagulants, e.g. iodoacetate, sodium citrate or those containing fluoride. Arterial blood is not recommended for use. Hemolyzed blood or thrombolytic therapy blood may lower the results. Venous occlusion might increase the results and is not recommended for blood draws. ## Special instrument requirements: Mission Cholesterol Meter and Mission Cholesterol Pro Meter ## Substantial Equivalence: ## Predicate device name: CardioChek Plus Test System and CardioChek Home Test System - K140068 {11}------------------------------------------------ # Comparison with predicate: # 1. Home Use | Features | Mission® Cholesterol<br>Monitoring System | CardioChek Home Test<br>System (K140068) | | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Comparison | | | | | Indications for Use | The Mission® Cholesterol<br>Monitoring System is intended for<br>the quantitative determination of<br>Total Cholesterol, High Density<br>Lipoprotein Cholesterol, and<br>Triglycerides in human capillary<br>whole blood from the fingertip.<br>The Mission Cholesterol<br>Monitoring System is a portable<br>system consisting of the Mission<br>Cholesterol Meter, Mission<br>Cholesterol Test Cartridges,<br>Mission Cholesterol Optical<br>Verifier and Mission Cholesterol<br>Control Solution, and is intended<br>to be used by a single person and<br>should not be shared. This system<br>is for in vitro diagnostic use only. | The CardioChek Home Test<br>System is a small portable<br>analyzer and test strip system for<br>self-testing by lay users. It is<br>intended to be used by a single<br>person and should not be shared.<br>This system is for in vitro<br>diagnostic use only. The tests<br>strips are for the quantitative<br>determination of glucose, total<br>cholesterol, HDL (high density<br>lipoprotein) cholesterol and<br>triglycerides in capillary whole<br>blood from the fingertip. A<br>Chol/HDL ratio<br>and estimated values for LDL<br>(low density lipoprotein)<br>cholesterol and non-HDL<br>cholesterol are calculated by<br>the CardioChek Plus<br>analyzer. | | | Intended Use/<br>Setting | The Mission® Cholesterol<br>Monitoring System is intended for<br>single person use, not to be shared. | Same as CardioChek Home<br>Test System | | | Methodology | Reflectance Photometer | Same | | | Test Time | < 2 min | < 90 seconds | | | Measurement<br>Range | CHOL: 100-400mg/dL (2.59-<br>10.36 mmol/L)<br>HDL: 15-100 mg/dL (0.39-2.59<br>mmol/L)<br>TRIG: 45-650 mg/dL (0.51-7.34<br>mmol/L) | CHOL: 100-400mg/dL (2.59-<br>10.36 mmol/L)<br>HDL: 15-100 mg/dL (0.39-2.59<br>mmol/L)<br>TRIG: 50-500 mg/dL (0.57-5.65<br>mmol/L) | | | Specimen | Capillary Whole Blood | Same | | | Calibration Coding | Automatic calibration by the code<br>chip | Same | | | Sample Volume | 35 µL (25-50 µL) | 15 to 40 µL | | | Units of<br>Measurement | mg/dL (default), mmol/L | Same | | | Operating<br>Conditions | 15 - 40°C (59 -104°F);<br>20-90% RH | 10-40°C (50-104°F),<br>Between 20 and 80% RH | | | Storage Conditions | 0 - 50°C (32 -122°F); ≤ 90% RH | Same | | | Hematocrit Range | CHOL, HDL, TRIG: 30-50% | CHOL: 30~50%<br>HDL: 30~45%<br>TG: 15~55% | | | Meter Connectors | USB cable for Printer or Power<br>(optional) | Same | | | Power Source | 4 AAA batteries (1.5V)<br>AC Adapter (Mini USB, 5V dc, 50 mA) | 4 AA batteries (1.5V) | | | Meter Size | Width: 3.11" (7.89 cm)<br>Length: 5.4" (13.7 cm)<br>Height: 1.02" (2.6 cm) | Width: 3.2 in (8.13 cm)<br>Length: 6.0 in (15.24 cm)<br>Height: 1.5 in (3.8 cm) | | | Meter Weight | 145g (without batteries) | 156g (without batteries) | | | Battery Life | 85 hours or 1,000 tests | 300 tests | | {12}------------------------------------------------ # 2. Professional Use | Features | Mission® Cholesterol Pro<br>Monitoring System | CardioChek Plus Test System<br>(K140068) | |----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Comparison | | | | Indications for Use | The Mission® Cholesterol Pro<br>Monitoring System is intended for<br>the quantitative determination of<br>Total Cholesterol, High Density<br>Lipoprotein Cholesterol, and<br>Triglycerides in human capillary | The CardioChek Plus Test<br>System is a small portable<br>analyzer and test strip system<br>intended for multiple patient use<br>in professional healthcare<br>settings. This system should only<br>be used with single-use, auto<br>disabling lancing devices. This | | | whole blood from fingertip and<br>lithium heparin venous whole<br>blood. The Mission® Cholesterol<br>Pro Monitoring System is a<br>portable system consisting of the<br>Mission Cholesterol Pro Meter,<br>Mission Cholesterol Pro Test<br>Cartridges, Mission Cholesterol<br>Optical Verifier and Mission<br>Cholesterol Control Solution, and<br>is intended for multiple patient use<br>in professional healthcare settings.<br>This system should only be used<br>with single-use, auto-disabling<br>lancing devices. This system is for<br>in vitro diagnostic use only. | system is for in vitro diagnostic<br>use only. The tests strips are for<br>the quantitative determination of<br>glucose, total cholesterol, HDL<br>(high density lipoprotein)<br>cholesterol and triglycerides in<br>venous whole blood and<br>capillary whole blood from the<br>fingertip. A Chol/HDL ratio and<br>estimated values for LDL (low<br>density lipoprotein) cholesterol<br>and non-HDL cholesterol are<br>calculated by the CardioChek<br>Plus analyzer. | | Specimen | Capillary and venous whole blood | Same | | Storage | • Store as packaged in the sealed<br>pouch, either at room<br>temperature or refrigerated.<br>• Temperature: 36-86°F, 2-30°C<br>• Do not freeze.<br>• Keep out of direct sunlight | Same | | Shelf life | Test cartridges are stable through<br>the expiration date printed on the<br>test cartridge foil pouch. | Same | | Enzyme | CHOL: Cholesterol esterase,<br>Cholesterol oxidase,<br>4-aminoantipyrine<br>HDL: Dextran sulphate,<br>cholesterol esterase, cholesterol<br>oxidase, 4-aminoantipyrine<br>TRIG: Lipoprotein lipase, glycerol<br>kinase, glycerol phosphate<br>oxidase, 4-aminoantipyrine | CHOL: Cholesterol esterase,<br>Cholesterol oxidase, Peroxidase<br>HDL: Cholesterol esterase,<br>Cholesterol oxidase, Peroxidase<br>TRIG: Lipase lipoprotein,<br>Glycerol kinase, Glycerol-3-<br>Phosphate Oxidase, Peroxidase | | Measurement<br>Range | CHOL: 100-400mg/dL (2.59-<br>10.36 mmol/L)<br>HDL: 15-100 mg/dL (0.39-2.59<br>mmol/L)<br>TRIG: 45-650 mg/dL (0.51-7.34<br>mmol/L) | CHOL: 100-400mg/dL (2.59-<br>10.36 mmol/L)<br>HDL: 15-100 mg/dL (0.39-2.59<br>mmol/L)<br>TRIG: 50-500 mg/dL (0.57-5.65<br>mmol/L) | | Meter Connectors | USB cable for Printer or Power<br>(optional) | Same | | | | | | Power Source | 4 AAA batteries (1.5V)<br>AC Adapter (Mini USB, 5V dc, 50 mA) | 4 AA batteries (1.5V) | | Meter Size | Width: 3.11” (7.89 cm)<br>Length: 5.4” (13.7 cm)<br>Height: 1.02” (2.6 cm) | Width: 3.2 in (8.13 cm)<br>Length: 6.0 in (15.24 cm)<br>Height: 1.5 in (3.8 cm) | | Meter Weight | 145g (without batteries) | 156g (without batteries) | | Battery Life | 85 hours or 1,000 tests | 300 tests | {13}------------------------------------------------ {14}------------------------------------------------ # Discussions of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: ### Laboratory Performance Testing: The performance characteristics of the Mission Cholesterol Monitoring System were verified by Precision study, Interference study, Temperature flex study, Humidity flex study, Sample volume flex , sensitivity study, hematocrit effect study, temperature effect study, stability study, meter performance validation, electrical safety testing and EMC testing. Laboratory testing results indicate that the Mission Cholesterol Monitoring System is robust and can perform satisfactorily when used with the test cartridges and control solution according to the "Indication for Use" statement specified in the Instruction Manual and Package Insert of the device. ### a. Precision Precision was determined according to the CLSI Guideline EP05-A3. The precision study was performed at three point-of-care (POC) sites using three lots of Mission® Cholesterol (and Pro) Test Cartridges. Precision studies were performed with whole blood samples and control solutions. To estimate different sources of variance, the data set was fitted to a Mixed Effects Model using the commercial software package lme4 (version: 1.1-12) in R (version 3.3.1). {15}------------------------------------------------ For laboratory workers testing precision with control solutions at three clinical sites, the following results were obtained: | | %CV | | | | | | |-----------------|-------------------|---------|-----------------------------|---------|---------------|---------| | | Total Cholesterol | | High Density<br>Lipoprotein | | Triglycerides | | | | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | | Repeatability | 1.5% | 1.6% | 2.0% | 1.6% | 1.3% | 1.6% | | Total precision | 2.0% | 1.8% | 2.7% | 2.3% | 2.0% | 1.9% | ### b. Linearity/ assay reportable range: A linearity study was performed according to NCCLS EP6-A at 9 concentration levels for each parameter and tested using 10 replicates each over three lots of the mission cholesterol test cartridges. This study demonstrates that the Mission® Cholesterol Test System is linear over the following reportable ranges: The measurement range of total cholesterol (100-400 mg/dL) is within the linear detection range. The measurement range of HDL (15-100 mg/dL) is within the linear detection range. The measurement range of triglyceride (45-650 mg/dL) is within the linear detection range. ## c. Traceability, Stability, Expected values (controls, calibrators, or methods): ### Traceability ACON Labs has documented traceability to the NCEP's recommended accuracy base for Total Cholesterol and HDL by performing a direct comparison with a Cholesterol Reference Method Laboratory Network (CRMLN) laboratory using fresh human specimens which cover the NCEP medical decision points. Triglyceride test is traceable to NIST standard. No calibration is required to perform the cholesterol test; however a lot specific code chip is provided with each test cartridge. The user must check and make sure that the code number printed on the test cartridge vial matches the code number displayed on the cholesterol meter before testing. {16}------------------------------------------------ ### Stability: Accelerated time stability studies were conducted to assess the shelf-life of test cartridges and it is estimated to be 18 months. ### Detection limit: Limit of blank, limit of detection and limit of quantitation studies were performed and support the following reportable measuring ranges: CHOL: 100-400mg/dL HDL: 15-100 mg/dL TRIG: 45-650 mg/dL ## d. Analytical specificity: Studies were performed according to CLSI guideline EP7-A2 to determine whether endogenous and exogenous substances interfere with the Mission Cholesterol Monitoring System's Cholesterol. HDL and Triglyceride assays. No Interference was observed for the following substances at the concentrations in the table below for total cholesterol (CHOL), HDL and Triglyceride (TG): | 1. Interference from Endogenous Substances | | | | |--------------------------------------------|------------|------------|------------| | Endogenous Substance | CHOL | HDL | TRIG | | Bilirubin | 15 mg/dL | 15 mg/dL | 33.2 mg/dL | | Creatinine | 5 mg/dL | 5 mg/dL | 5 mg/dL | | Hemoglobin | 500 mg/dL | 500 mg/dL | 500 mg/dL | | Uric acid | 12 mg/dL | 12 mg/dL | 23.5 mg/dL | | Cholesterol | / | / | 502 mg/dL | | Triglyceride | 649 mg/L | 649 mg/L | / | | 2. Interference from Exogenous Substances | | | | | Exogenous Substance | CHOL | HDL | TRIG | | Acetylsalicylic acid | 65 mg/dL | 65 mg/dL | 65 mg/dL | | Acetaminophen | 20 mg/dL | 20 mg/dL | 20 mg/dL | | Atorvastatin | 0.06 mg/dL | 0.06 mg/dL | 0.06 mg/dL | | Ampicillin | 5.3 mg/dL | 5.3 mg/dL | 5.3 mg/dL | | Ascorbic acid | 10 mg/dL | 10 mg/dL | 10 mg/dL | | Bezafibrate | 10 mg/dL | 10 mg/dL | 10 mg/dL | | Dopamine | 0.09 mg/dL | 0.09 mg/dL | 0.09 mg/dL | | Furosemide | 6 mg/dL | 6 mg/dL | 6 mg/dL | | Gentisic acid | 1.8 mg/dL | 1.8 mg/dL | 1.8 mg/dL | | Glybenclamide | 1 mg/dL | 1 mg/dL | 1 mg/dL | {17}------------------------------------------------ | Ibuprofen | 50 mg/dL | 50 mg/dL | 50 mg/dL | |----------------------------------------|-----------|-----------|-----------| | Indomethacin | 3.6 mg/dL | 3.6 mg/dL | 3.6 mg/dL | | Methyldopa | 1.5 mg/dL | 1.5 mg/dL | 1.5 mg/dL | | Nicotinic acid | 0.1 mg/dL | 0.1 mg/dL | 0.1 mg/dL | | Probenecid | 60 mg/dL | 60 mg/dL | 60 mg/dL | | Quinidine hydrochloride<br>monohydrate | 1.2 mg/dL | 1.2 mg/dL | 1.2 mg/dL | | Salicylic acid | 60 mg/dL | 60 mg/dL | 60 mg/dL | | Sulfamethoxazole | 40 mg/dL | 40 mg/dL | 40 mg/dL | | Trimethoprim | 4 mg/dL | 4 mg/dL | 4 mg/dL | Limitations: - High concentrations of uric acid (≥12 mg/dL) can lead to falsely low measurements for Total ● Cholesterol and HDL Cholesterol. - . High concentrations of bilirubin (≥15 mg/dL) can lead to falsely low measurements for Total Cholesterol and HDL Cholesterol. ### Discussion of Clinical Tests Performed: The clinical study followed the FDA's "Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians' Office Laboratory and Home Use." A total of 369 patients were recruited for the study at three POL sites located in different geographical locations. The study design incorporated testing for both professional use and self-testing. For professional use, patient blood was collected from fingertip and venous blood draws. Capillary blood samples from fingertip were tested at clinical sites by professionals. Venous blood samples were tested at a laboratory using an FDA cleared method. For self-testing, laypersons followed the product package insert and performed the test with their capillary finger blood from fingers using Mission® Cholesterol Monitoring System and test cartridge. {18}------------------------------------------------ Finger blood and venous blood specimens were collected from 369 laypersons at three clinical sites and were tested with Mission® Cholesterol Test Cartridges by medical professionals and laypersons. The plasma concentration was confirmed by the reference method. The tables below show the regression correlation values: ### Total cholesterol | Operator | Specimen | Linearity | R2 | No. of Specimens | |--------------------------|------------------|------------------|--------|------------------| | Layperson | Finger capillary | Y=0.9994X+0.0293 | 0.9846 | 369 | | Professional<br>Operator | Finger capillary | Y=1.0016X-0.5139 | 0.9883 | 369 | | Professional<br>Operator | Heparin Venous | Y=0.9889X+0.807 | 0.9863 | 369 | ### HDL cholesterol | Operator | Specimen | Linearity | R2 | No. of Specimens | |--------------------------|------------------|------------------|--------|------------------| | Layperson | Finger capillary | Y=0.99X+0.0989 | 0.9768 | 369 | | Professional<br>Operator | Finger capillary | Y=1.0015X-0.1705 | 0.9778 | 369 | | Professional<br>Operator | Heparin Venous | Y=0.9929X+1.052 | 0.9790 | 369 | # Triglycerides | Operator | Specimen | Linearity | R2 | No. of Specimens | |--------------------------|------------------|--------------------|--------|--------------…
Innolitics
510(k) Summary
Decision Summary
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