Mission Lipid Panel Monitoring System by ACON Laboratories, Inc.

The Mission® Lipid Panel Monitoring System is intended for the quantitative determination of Total Cholesterol. High Density Lipoprotein Cholesterol, and Triglycerides in human capillary whole blood from the fingerin venous whole blood. The Mission® Lipid Panel Monitoring System consisting of the Mission® Lipid Panel Meter, Mission® Lipid Panel 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 Pro Meter and is reported only when Triglycerides are ≤400 mg/dL.

Device Description

Not Found

AI/ML Overview

The document provided (K180504) is a 510(k) premarket notification for the Mission Lipid Panel Monitoring System. Based on the content, this device is a quantitative assay system for measuring Total Cholesterol, HDL-C, and Triglycerides, primarily used in professional healthcare settings. It is NOT an AI/ML powered device, nor does it involve image analysis by experts, or require MRMC studies.

Therefore, many of the requested criteria (like number of experts, adjudication methods, multi-reader multi-case studies, effect size of human improvement with AI, training set details, etc.) are not applicable to this type of medical device and the information is not present in the provided document.

However, I can extract the acceptance criteria and performance data relevant to a clinical chemistry device, which typically involves analytical accuracy and precision.

Here's an attempt to answer the request based only on the provided document, acknowledging the limitations for an AI/ML context:

The Mission Lipid Panel Monitoring System is a quantitative in vitro diagnostic device. The documentation provided focuses on clinical chemistry performance, not AI/ML algorithm performance. As such, many of the acceptance criteria and study details commonly associated with AI/ML devices (e.g., number of experts, MRMC studies, training set details, ground truth for image analysis) are not relevant or provided for this device type.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K180504) is a 510(k) clearance letter and an Indications for Use statement. It does not contain the detailed performance data or the specific acceptance criteria tables that would typically be part of the predicate comparison or detailed validation studies submitted to the FDA. The letter only states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

To illustrate what would typically be found for a quantitative diagnostic like this, and based on common regulatory expectations for lipid panels, performance would involve metrics like:

Performance Metric	Acceptance Criteria (Illustrative - Not explicitly stated in the provided document, but typical for lipid panels)	Reported Device Performance (Illustrative - Not explicitly stated in the provided document)
Accuracy (Bias)	For each analyte (Total Cholesterol, HDL-C, Triglycerides), often assessed against a reference method (e.g., CDC-certified laboratory correlation). Criteria might be expressed as a percentage of bias or absolute bias within clinically acceptable limits for different concentration ranges.	e.g., Total Cholesterol: Bias within ±5% or ±X mg/dL compared to reference method.
Precision (Reproducibility)	Within-run, between-run, and total precision (CV% or SD) for each analyte at different concentration levels (low, medium, high). Criteria based on CLIA or professional guidelines.	e.g., HDL-C: CV% < 5% at clinically relevant concentrations.
Linearity/Reportable Range	The device should demonstrate linear response across the entire claimed measurement range for each analyte.	Demonstrated linearity across the stated measurement ranges for each analyte.
Interference	No significant interference from common endogenous substances (e.g., hemoglobin, bilirubin, triglycerides for cholesterol measurements) or exogenous substances (common medications).	Showed no significant interference from tested substances within specified limits.
Method Comparison	Strong correlation (e.g., R-squared > 0.95) and acceptable agreement (e.g., Bland-Altman plots) with a predicate device or established reference method.	Strong correlation and agreement with predicate device/reference method.
User Performance/Lay User Study (if applicable, though this is professional use)	For professional use, demonstrates acceptable performance across different users or sites.	Performance consistent across different operators in a professional setting.

Important Note: The provided document does not contain any of these specific performance values or acceptance criteria. It is a regulatory clearance letter, not a summary of the validation study.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Such details would be found in the more detailed 510(k) submission or a summary of safety and effectiveness, neither of which is part of this provided extract.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This device measures chemical analytes (Total Cholesterol, HDL-C, Triglycerides). The "ground truth" for such measurements is typically established by reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry (GC-MS), or high-performance liquid chromatography (HPLC)) traceable to international standards (e.g., CDC Lipid Standardization Program). It does not involve human expert interpretation of images or complex diagnostic reasoning.

4. Adjudication Method for the Test Set

Not applicable, as ground truth is established by objective laboratory methods, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. MRMC studies are relevant for imaging devices where human readers interpret medical images. This device is a quantitative diagnostic instrument that measures chemical concentrations.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an analytical instrument; its "performance" is its ability to accurately and precisely measure analytes. While there's an "algorithm" for calculating LDL-C (Friedewald formula), its performance is assessed through the accuracy of the underlying direct measurements (TC, HDL-C, TG) and comparison of the calculated LDL-C to a reference method, not typically in a "standalone algorithm" context as understood for image analysis AI.

7. The Type of Ground Truth Used

The ground truth for a device like the Mission Lipid Panel Monitoring System would be established by:

Reference Laboratory Methods: Highly accurate and precise laboratory methods (e.g., those traceable to the CDC Lipid Standardization Program or other certified reference methods) for Total Cholesterol, HDL-C, and Triglycerides.
Certified Reference Materials: Use of materials with known, established concentrations of the analytes.

8. The Sample Size for the Training Set

Not applicable in the context of AI/ML training. This device is likely based on established electrochemical or photometric principles, not on a machine learning model "trained" on a dataset of patient samples in the AI sense. Performance is validated through analytical studies on patient samples and quality control materials.

9. How the Ground Truth for the Training Set was Established

Not applicable. As noted above, this is not an AI/ML device that requires a "training set" in that context. Its analytical method is based on established chemical principles. Validation is done against reference methods and materials, as described in point 7.

Summary

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March 28, 2018

ACON Laboratories, Inc. Qiyi Xie Director Regulatory/Clinical Affairs 10125 Mesa Rim Road San Diego, CA 92121

Re: K180504

Trade/Device Name: Mission Lipid Panel Monitoring System Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I, meets the limitation to the exemption 21 CFR 862.9(c)(4) Product Code: CHH, JGY, LBR Dated: February 23, 2018 Received: February 26, 2018

Dear 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 Part 801 and Part 809); medical device 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

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K180504

Device Name Mission® Lipid Panel Monitoring System

Indications for Use (Describe)

An estimated value for Low Density Lipoprotein Cholesterol is calculated by the Mission Cholesterol Pro 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)

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Regulation Number and Section

§ 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.