(218 days)
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 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.
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.
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.
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.
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.
Here's a summary of the acceptance criteria and study findings for the Mission Cholesterol Monitoring System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" values in a table. However, the linearity, precision, and bias data are direct measures of performance against presumed internal or regulatory benchmarks for acceptable accuracy and precision in cholesterol measurement devices. We will infer the reported device performance from the study results presented.
| Performance Metric | Acceptance Criteria (Implied/Industry Norms) | Reported Device Performance - Total Cholesterol | Reported Device Performance - HDL Cholesterol | Reported Device Performance - Triglycerides |
|---|---|---|---|---|
| Precision (Repeatability %CV) | Generally <5% for diagnostic devices (Level 1, Level 2) | Level 1: 1.5%, Level 2: 1.6% | Level 1: 2.0%, Level 2: 1.6% | Level 1: 1.3%, Level 2: 1.6% |
| Precision (Total Precision %CV) | Generally <10% for diagnostic devices (Level 1, Level 2) | Level 1: 2.0%, Level 2: 1.8% | Level 1: 2.7%, Level 2: 2.3% | Level 1: 2.0%, Level 2: 1.9% |
| Linearity (Measurement Range) | Device should be linear within its claimed measurement range | 100-400 mg/dL (linear detection range) | 15-100 mg/dL (linear detection range) | 45-650 mg/dL (linear detection range) |
| Correlation ($R^2$) - Layperson, Finger Capillary | Typically >0.90 for good correlation | 0.9846 | 0.9768 | 0.9934 |
| Correlation ($R^2$) - Professional, Finger Capillary | Typically >0.90 for good correlation | 0.9883 | 0.9778 | 0.9948 |
| Correlation ($R^2$) - Professional, Heparin Venous | Typically >0.90 for good correlation | 0.9863 | 0.9790 | 0.9936 |
| % Bias at Medical Decision Points (Finger Blood) | Generally within ±5-10% for clinical acceptability | (-0.1% at 200mg/dL, -0.1% at 240mg/dL) | (-0.3% at 40mg/dL, -0.1% at 60mg/dL) | (0.3% at 150mg/dL, 0.0% at 200mg/dL, -0.2% at 500mg/dL) |
| % Bias at Medical Decision Points (Venous Blood) | Generally within ±5-10% for clinical acceptability | (-0.7% at 200mg/dL, -0.8% at 240mg/dL) | (1.9% at 40mg/dL, 1.0% at 60mg/dL) | (-1.8% at 150mg/dL, -1.5% at 200mg/dL, -1.2% at 500mg/dL) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 369 patients were recruited for the clinical study.
- Data Provenance: The study was conducted at three point-of-care (POC) sites located in different geographical locations. It is a prospective clinical study as patients were recruited and tested specifically for this study. The country of origin is not explicitly stated, but given the FDA submission, it can be inferred to be compliant with US regulatory standards, likely involving data collected within the US or under equivalent standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts. However, it mentions:
- "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."
- "The plasma concentration was confirmed by the reference method."
This implies that trained "professionals" (likely medical technicians or laboratory personnel) performed the official comparative testing, and an FDA-cleared reference method was used to establish the ground truth. No specific number or qualification (e.g., "radiologist with 10 years of experience") for these "professionals" is given beyond their professional role in clinical sites or laboratories.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1). The ground truth was established by comparing the device's results to an "FDA cleared method" and a "reference method" in laboratory settings. This suggests direct quantitative comparison rather than a consensus-based adjudication process typical for qualitative or image-based diagnostics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or performed in the context of improving human reader performance with AI assistance. This study focuses on the device's standalone analytical performance compared to a reference method, and also includes layperson use, not assisted reading by human experts.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance study was done for the device. The entire clinical study, comparing the Mission Cholesterol Monitoring System's measurements against a reference method, evaluates the algorithm's performance. Both professional operators and laypersons used the device independently to obtain results, which were then compared to the established ground truth.
7. The Type of Ground Truth Used
The ground truth for the clinical study was established by comparing the device's results to an FDA cleared method and a reference method (for plasma concentration).
8. The Sample Size for the Training Set
The document does not provide information regarding a separate training set or its sample size. The studies described are for the validation of an already developed device.
9. How the Ground Truth for the Training Set Was Established
As no training set is described, there's no information on how its ground truth would have been established. The provided document focuses on the validation of the device through performance and clinical studies.
{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) | |||
|---|---|---|---|
| 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."
{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) | |
|---|---|
| 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 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 -Classification | Product Code | Description |
|---|---|---|---|
| Mission® CholesterolMonitoring System | 21 CFR 862.1175 –Class I | CHH | Cholesterol (total) TestSystem |
| Mission® CholesterolMeter | 21 CFR 862.1705 –Class I | JGY | Triglyceride Test System |
| Mission® CholesterolTest 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® CholesterolPro MonitoringSystem | 21 CFR 862.1175 –Class I | CHH | Cholesterol (total) TestSystem |
| Mission® CholesterolPro Meter | 21 CFR 862.1705 –Class I | JGY | Triglyceride Test System |
| Mission® CholesterolPro Test Cartridges | 21 CFR 862.1475 –Class I | LBR | Lipoprotein Test System |
{6}------------------------------------------------
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.
{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 |
| MeasurementRange | CHO: 100-400mg/dL (2.59-10.36 mmol/L,1mmol/l=38.66mg/dL )HDL: 15-100 mg/dL (0.39-2.59 mmol/L, 1mmol/l=38.66mg/dL)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)AC Adapter (Mini USB, 5V dc, 50 mA) |
| Battery Life | 85 hours or 1,000 tests |
| Units ofMeasurement | 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 StorageConditions | 0 - 50°C (32 -122°F); ≤ 90% RH |
| OperatingConditions | 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® CholesterolMonitoring System | CardioChek Home TestSystem (K140068) | |
|---|---|---|---|
| Comparison | |||
| Indications for Use | The Mission® CholesterolMonitoring System is intended forthe quantitative determination ofTotal Cholesterol, High DensityLipoprotein Cholesterol, andTriglycerides in human capillarywhole blood from the fingertip.The Mission CholesterolMonitoring System is a portablesystem consisting of the MissionCholesterol Meter, MissionCholesterol Test Cartridges,Mission Cholesterol OpticalVerifier and Mission CholesterolControl Solution, and is intendedto be used by a single person andshould not be shared. This systemis for in vitro diagnostic use only. | The CardioChek Home TestSystem is a small portableanalyzer and test strip system forself-testing by lay users. It isintended to be used by a singleperson and should not be shared.This system is for in vitrodiagnostic use only. The testsstrips are for the quantitativedetermination of glucose, totalcholesterol, HDL (high densitylipoprotein) cholesterol andtriglycerides in capillary wholeblood from the fingertip. AChol/HDL ratioand estimated values for LDL(low density lipoprotein)cholesterol and non-HDLcholesterol are calculated bythe CardioChek Plusanalyzer. | |
| Intended Use/Setting | The Mission® CholesterolMonitoring System is intended forsingle person use, not to be shared. | Same as CardioChek HomeTest System | |
| Methodology | Reflectance Photometer | Same | |
| Test Time | < 2 min | < 90 seconds | |
| MeasurementRange | CHOL: 100-400mg/dL (2.59-10.36 mmol/L)HDL: 15-100 mg/dL (0.39-2.59mmol/L)TRIG: 45-650 mg/dL (0.51-7.34mmol/L) | CHOL: 100-400mg/dL (2.59-10.36 mmol/L)HDL: 15-100 mg/dL (0.39-2.59mmol/L)TRIG: 50-500 mg/dL (0.57-5.65mmol/L) | |
| Specimen | Capillary Whole Blood | Same | |
| Calibration Coding | Automatic calibration by the codechip | Same | |
| Sample Volume | 35 µL (25-50 µL) | 15 to 40 µL | |
| Units ofMeasurement | mg/dL (default), mmol/L | Same | |
| OperatingConditions | 15 - 40°C (59 -104°F);20-90% RH | 10-40°C (50-104°F),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 | |
| Meter Connectors | USB cable for Printer or Power(optional) | Same | |
| Power Source | 4 AAA batteries (1.5V)AC Adapter (Mini USB, 5V dc, 50 mA) | 4 AA batteries (1.5V) | |
| Meter Size | Width: 3.11" (7.89 cm)Length: 5.4" (13.7 cm)Height: 1.02" (2.6 cm) | Width: 3.2 in (8.13 cm)Length: 6.0 in (15.24 cm)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 ProMonitoring System | CardioChek Plus Test System(K140068) |
|---|---|---|
| Comparison | ||
| Indications for Use | The Mission® Cholesterol ProMonitoring System is intended forthe quantitative determination ofTotal Cholesterol, High DensityLipoprotein Cholesterol, andTriglycerides in human capillary | The CardioChek Plus TestSystem is a small portableanalyzer and test strip systemintended for multiple patient usein professional healthcaresettings. This system should onlybe used with single-use, autodisabling lancing devices. This |
| whole blood from fingertip andlithium heparin venous wholeblood. The Mission® CholesterolPro Monitoring System is aportable system consisting of theMission Cholesterol Pro Meter,Mission Cholesterol Pro TestCartridges, Mission CholesterolOptical Verifier and MissionCholesterol Control Solution, andis intended for multiple patient usein professional healthcare settings.This system should only be usedwith single-use, auto-disablinglancing devices. This system is forin vitro diagnostic use only. | system is for in vitro diagnosticuse only. The tests strips are forthe quantitative determination ofglucose, total cholesterol, HDL(high density lipoprotein)cholesterol and triglycerides invenous whole blood andcapillary whole blood from thefingertip. A Chol/HDL ratio andestimated values for LDL (lowdensity lipoprotein) cholesteroland non-HDL cholesterol arecalculated by the CardioChekPlus analyzer. | |
| Specimen | Capillary and venous whole blood | Same |
| Storage | • Store as packaged in the sealedpouch, either at roomtemperature or refrigerated.• Temperature: 36-86°F, 2-30°C• Do not freeze.• Keep out of direct sunlight | Same |
| Shelf life | Test cartridges are stable throughthe expiration date printed on thetest cartridge foil pouch. | Same |
| Enzyme | CHOL: Cholesterol esterase,Cholesterol oxidase,4-aminoantipyrineHDL: Dextran sulphate,cholesterol esterase, cholesteroloxidase, 4-aminoantipyrineTRIG: Lipoprotein lipase, glycerolkinase, glycerol phosphateoxidase, 4-aminoantipyrine | CHOL: Cholesterol esterase,Cholesterol oxidase, PeroxidaseHDL: Cholesterol esterase,Cholesterol oxidase, PeroxidaseTRIG: Lipase lipoprotein,Glycerol kinase, Glycerol-3-Phosphate Oxidase, Peroxidase |
| MeasurementRange | CHOL: 100-400mg/dL (2.59-10.36 mmol/L)HDL: 15-100 mg/dL (0.39-2.59mmol/L)TRIG: 45-650 mg/dL (0.51-7.34mmol/L) | CHOL: 100-400mg/dL (2.59-10.36 mmol/L)HDL: 15-100 mg/dL (0.39-2.59mmol/L)TRIG: 50-500 mg/dL (0.57-5.65mmol/L) |
| Meter Connectors | USB cable for Printer or Power(optional) | Same |
| Power Source | 4 AAA batteries (1.5V)AC Adapter (Mini USB, 5V dc, 50 mA) | 4 AA batteries (1.5V) |
| Meter Size | Width: 3.11” (7.89 cm)Length: 5.4” (13.7 cm)Height: 1.02” (2.6 cm) | Width: 3.2 in (8.13 cm)Length: 6.0 in (15.24 cm)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 DensityLipoprotein | 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 hydrochloridemonohydrate | 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 |
| ProfessionalOperator | Finger capillary | Y=1.0016X-0.5139 | 0.9883 | 369 |
| ProfessionalOperator | 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 |
| ProfessionalOperator | Finger capillary | Y=1.0015X-0.1705 | 0.9778 | 369 |
| ProfessionalOperator | Heparin Venous | Y=0.9929X+1.052 | 0.9790 | 369 |
Triglycerides
| Operator | Specimen | Linearity | R2 | No. of Specimens |
|---|---|---|---|---|
| Layperson | Finger capillary | $Y=0.9983X+0.8927$ | 0.9934 | 369 |
| ProfessionalOperator | Finger capillary | $Y=0.9965X+0.9441$ | 0.9948 | 369 |
| ProfessionalOperator | Heparin Venous | $Y=0.9901X-1.2099$ | 0.9936 | 369 |
{19}------------------------------------------------
| Total Cholesterol | ||
|---|---|---|
| Specimen | 200 mg/dL | 240 mg/dL |
| Finger Blood | -0.1% | -0.1% |
| Venous Blood | -0.7% | -0.8% |
| HDL | ||
| Specimen | 40 mg/dL | 60 mg/dL |
| Finger Blood | -0.3% | -0.1% |
| Venous Blood | 1.9% | 1.0% |
% Bias of Mission Cholesterol Monitoring System at Medical Decision Points
| Triglyceride | |||
|---|---|---|---|
| Specimen | 150 mg/dL | 200 mg/dL | 500 mg/dL |
| Finger Blood | 0.3% | 0.0 % | -0.2% |
| Venous Blood | -1.8% | -1.5% | -1.2% |
Conclusion:
The laboratory performance testing and clinical study results demonstrate that the Mission Cholesterol and Mission Cholesterol Pro Monitoring System and Test Cartridges are safe, effective and easy-to-use and as such is substantially equivalent to the predicate devices currently sold on the U.S. market.
§ 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.