(218 days)
Not Found
No
The device description and performance studies focus on reflectance photometry and standard analytical methods, with no mention of AI or ML. The calculation of estimated LDL is a simple formula based on other measured values, not an AI/ML algorithm.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of cholesterol and triglycerides in blood, which aids in diagnosis and treatment monitoring but does not directly provide therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders." This indicates the device is used for diagnostic purposes. Furthermore, it is described as "for in vitro diagnostic use only."
No
The device description explicitly states that the system consists of a "Mission Cholesterol Meter" which is an "in vitro diagnostic device consisting of a reflectance photometer". This is a hardware component that performs the measurement. The system also includes test cartridges, control solution, and an optical verifier, all of which are physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section for both the home use and professional systems: "This system is for in vitro diagnostic use only."
Furthermore, the "Device Description" section for both systems describes the meter as an "in vitro diagnostic device".
The intended use of measuring Total Cholesterol, HDL Cholesterol, and Triglycerides in human blood for the diagnosis and treatment of various disorders also aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Mission® Cholesterol Monitoring System (home 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
§ 862.1175 Cholesterol (total) test system.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a 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
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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 Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | | | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | | | |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"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."
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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 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.
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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)
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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 -
Classification | Product Code | Description |
|-------------------------------------------|--------------------------------|--------------|------------------------------------|
| Mission® Cholesterol
Monitoring System | 21 CFR 862.1175 –
Class I | CHH | Cholesterol (total) Test
System |
| Mission® Cholesterol
Meter | 21 CFR 862.1705 –
Class I | JGY | Triglyceride Test System |
| Mission® Cholesterol
Test Cartridges | 21 CFR 862.1475 -
Class I | LBR | Lipoprotein Test System |
2) Mission® Cholesterol Pro monitoring system (professional use):
| Proprietary Name | Regulation -
Classification | Product Code | Description |
|--------------------------------------------------|--------------------------------|--------------|------------------------------------|
| Mission® Cholesterol
Pro Monitoring
System | 21 CFR 862.1175 –
Class I | CHH | Cholesterol (total) Test
System |
| Mission® Cholesterol
Pro Meter | 21 CFR 862.1705 –
Class I | JGY | Triglyceride Test System |
| Mission® Cholesterol
Pro Test Cartridges | 21 CFR 862.1475 –
Class I | LBR | Lipoprotein Test System |
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Device Description:
-
- 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.
- 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.
-
- 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.
- 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.
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.
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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 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
Monitoring System | CardioChek Home Test
System (K140068) | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Comparison | | | |
| Indications for 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. | The CardioChek Home Test
System is a small portable
analyzer and test strip system for
self-testing by lay users. It is
intended to be used by a single
person and should not be shared.
This system is for in vitro
diagnostic use only. The tests
strips are for the quantitative
determination of glucose, total
cholesterol, HDL (high density
lipoprotein) cholesterol and
triglycerides in capillary whole
blood from the fingertip. A
Chol/HDL ratio
and estimated values for LDL
(low density lipoprotein)
cholesterol and non-HDL
cholesterol are calculated by
the CardioChek Plus
analyzer. | |
| Intended Use/
Setting | The Mission® Cholesterol
Monitoring System is intended for
single person use, not to be shared. | Same as CardioChek Home
Test System | |
| Methodology | Reflectance Photometer | Same | |
| Test Time |