The Cholestech LDX™ System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only and should not be used for testing in children under the age of 2 years. The Cholestech LDX™ System is comprised of the Cholestech LDX Analyzer and the following cassettes:

The Lipid Profile GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density Ilpoprotein) cholesterol, triglycerides and glucose in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL GLU cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, and glucose in whole blood.

The TC GLU cassette is for the quantitative determination of total cholesterol and glucose in whole blood.

The Lipid Profile cassette is for the quantitative determination of total cholesterol. HDL (high-density lipoprotein) cholesterol, and triglycerides in whole blood. The TC/HDL (total cholesterol) ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are also reported.

The TC+HDL cassette is for the quantitative determination of total cholesterol and HDL (high-density lipoprotein) cholesterol in whole blood.

The TC cassette is for the quantitative determination of total cholesterol in whole blood.

· Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

· HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

· Triglyceride measurements are used in the diagnosis and treatment with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

· Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Device Description

The Cholestech LDX ™ system combines enzymatic methodology and solid-phase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to the Cholestech LDX™ cassette®.

The cassette is then placed into the Cholestech LDX™ Analyzer where a unique system on the cassette separates the plasma from the blood cells. A portion of the plasma flows to the right side of the cassette and is transferred to both the total cholesterol and triglyceride reaction pads. Simultaneously, plasma flows to the left side of the cassette where the low- and very low-density lipoproteins (LDL and VLDL) are precipitated with dextran sulfate (50,000 MW) and magnesium acetate precipitating reagent.The filtrate, containing both glucose and HDL cholesterol, is transferred to both the glucose and HDL cholesterol reaction pads.

The Cholestech LDX ™ Analyzer measures total cholesterol and HDL cholesterol by an enzymatic method based on the method formulation of Allain et al, and Roeschlau. Cholesterol esterase hydrolyzes the cholesterol esters in the filtrate or plasma to free cholesterol and the corresponding fatty acid. Cholesterol oxidase, in the presence of oxygen, oxidizes free cholesterol to cholest-4-ene-3-one and hydrogen peroxide. In a reaction catalyzed by horseradish peroxidase, the peroxide reacts with 4-Aminoantipyrine and N-ethyl-N-sulfohydroxypropyl-m-toluidine, sodium sale (TOOS) to form a purple-colored quinoneimine dye proportional to the total cholesterol and HDL cholesterol concentrations of the sample.

The analyzer measures triglycerides by an enzymatic method based on the hydrolysis of triglycerides by lipase to glycerol and free fatty acids. Glycerol, in a reaction catalyzed by glycerol kinase, is converted to glycerol-3-phosphate. In a third reaction, glycerol-3phosphate is oxidized by glycerol phosphate oxidase to dihydroxyacetone phosphate and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as for the total cholesterol and HDL cholesterol. Estimated LDL cholesterol and non-HDL cholesterol and a TC/HDL ratio are calculated using the measured values for TC, HDL, and Triglycerides.

The analyzer measures glucose by an enzymatic method that uses glucose oxidase to catalyze the oxidation of glucose to gluconolactone and hydrogen peroxide. The color reaction utilizing horseradish peroxidase is the same as that for total cholesterol, HDL cholesterol and triglycerides. The resultant color in all the reactions is measured by reflectance photometry.

A brown (magnetic) stripe on each cassette contains the calibration information required for the Cholestech LDX ™ Analyzer to convert the reflectance reading (% R) to the total cholesterol, HDL cholesterol, triglycerides and glucose concentrations.

AI/ML Overview

The provided text is a 510(k) summary for the Cholestech LDX™ System and primarily discusses device modifications and comparison to a predicate device. It certifies that verification studies were performed as required by risk analysis and all acceptance criteria were met. However, it does not provide the specific details of the acceptance criteria or the reported device performance for these studies. It also does not contain information about the sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for test and training sets.

Therefore, based solely on the provided text, I cannot fulfill most of the requested information regarding the study that proves the device meets the acceptance criteria. The document states that such studies were done and met acceptance criteria, but omits the specifics.

Here's what can be inferred or stated from the provided text, and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Information Not Available in the Text: The document explicitly states, "Verification studies were performed as required by risk analysis and all acceptance criteria were met." However, it does not list the specific acceptance criteria (e.g., specific accuracy thresholds, precision ranges, etc.) or the detailed reported device performance (e.g., actual measured accuracy, precision values, etc.) from these studies. The modification pertains to updating the performance claim related to conjugated and unconjugated Bilirubin interference. While it mentions that less than 10% interference was seen at specified levels for various substances, this is a general statement from the predicate device's limitations, not a specific acceptance criterion for the current modification or the exact performance data achieved.

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

Information Not Available in the Text: The document states that "verification studies" were performed, but it does not specify the sample size (e.g., number of patients, number of samples) used for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective nature of the data collection).

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

Information Not Available in the Text: The document details changes to an in vitro diagnostic (IVD) device for measuring cholesterol, triglycerides, and glucose. For IVD devices, ground truth is typically established by reference laboratory methods, not by human experts interpreting images or clinical cases. Therefore, the concept of "experts" as in radiologists or pathologists establishing ground truth is not applicable here. Even if it were (e.g., for method comparison studies requiring expert clinical correlation), the document does not mention any role for experts in establishing ground truth.

4. Adjudication Method for the Test Set

Information Not Available in the Text: Since the ground truth for an IVD device is generally established using reference methods (as opposed to human interpretation needing adjudication), an adjudication method as typically used in AI studies of imaging (e.g., 2+1, 3+1) is not applicable or described in this document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Information Not Applicable/Available in the Text: This is an in vitro diagnostic (IVD) device, not an AI-assisted diagnostic imaging device. Therefore, MRMC studies comparing human readers with and without AI assistance are not relevant to this type of device and are not mentioned in the documentation.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Information Not Applicable/Available in the Text: The Cholestech LDX™ System is a chemical analyzer, not an AI algorithm. Its performance is inherent to the device's enzymatic and solid-phase technology. The concept of "standalone algorithm performance" without human-in-the-loop is not directly applicable in the same way it would be for a software-as-a-medical-device (SaMD) that processes and interprets data for human review. The document describes the device's direct measurement capabilities.

7. The Type of Ground Truth Used

Inferred from Text: For an in vitro diagnostic device measuring analytes (cholesterol, HDL, triglycerides, glucose), the ground truth is typically established by reference laboratory methods (e.g., highly accurate and precise methods run on core laboratory instruments). While the document does not explicitly state "reference laboratory comparison" for ground truth, the context of an IVD device submission, especially one measuring these specific analytes, strongly implies this method.

8. The Sample Size for the Training Set

Information Not Applicable/Available in the Text: This is a chemical analyzer, not a machine learning or AI-based device that requires a "training set" in the computational sense. The device's operation is based on established enzymatic and chemical reactions, not on data-driven learning. Therefore, there is no "training set" in the context of AI/ML.

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

Information Not Applicable/Available in the Text: As noted above, there is no "training set" for this type of IVD device in the context of AI/ML. The device's calibration and performance are based on chemical principles and validation studies, not on learning from a training dataset.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 20, 2023

Alere San Diego, Inc. Nathifa Bradshaw Manager, Regulatory Affairs 9942 Mesa Rim Road San Diego, California 92121

Re: K223179

Trade/Device Name: Cholestech LDX TM System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, CHH, LBS, JGY, JJE Dated: June 6, 2023 Received: June 6, 2023

Dear Nathifa Bradshaw:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Paula V. Caposino -S

Paula Caposino, Ph.D. Acting Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223179

Device Name Cholestech LDX™ System

Indications for Use (Describe)