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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.

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.

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.

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The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Signify® H. pylori cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Clearview® H. pylori test is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to Helicobacter pylori in whole blood to aid in the diagnosis of H. pylori infection in adults 18 years of age and older.

The Alere H. pylori tests are lateral flow immunochromatographic assays for the qualitative detection of Immunoglobulin G (IgG) antibodies to Helicobacter pylori (H. pylori) in whole blood, serum and plasma. The test devices consist of a membrane strip coated with immobilized human IgG antibodies and H. pylori antigen encased in a plastic housing. In the test procedure, anti-human IgG is immobilized in the test line region of the cassette. The sample reacts with H. pylori antigen-coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region indicating a positive result. If the sample does not contain H. pylori IgG antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of sample has been added and membrane wicking has occurred.

The provided text describes a 510(k) premarket notification for Alere Signify® H. pylori and Alere Clearview® H. pylori tests, which are rapid chromatographic immunoassays for the qualitative detection of IgG antibodies to Helicobacter pylori.

Here's an analysis of the acceptance criteria and study information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in a table format with specific thresholds (e.g., Sensitivity > X%, Specificity > Y%). Instead, it describes a performance study related to interfering substances and concludes substantial equivalence based on the device's expected performance and lack of interference.

• Implied Acceptance Criterion: The tests should produce expected (correct) positive or negative results in the presence of various interfering substances.
• Reported Device Performance: All negative and positive H. pylori samples tested as expected, with no false results, even in the presence of high levels of triglycerides.

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

• Sample Size:
  • For the interfering substance study related to triglycerides:
    • H. pylori standards: low positive (presumably 1 sample) and high positive (presumably 1 sample).
    • H. pylori negative plasma sample: 1 sample.
    • Each of these 3 samples was spiked with two concentrations of triglyceride reference material.
    • Each spiked sample was tested in replicates of three.
    • Three unspiked replicates of each H. pylori standard and negative sample were also tested.
    • Calculation: (2 positive standards + 1 negative sample) * (2 triglyceride concentrations * 3 replicates + 3 unspiked replicates) = 3 * (6 + 3) = 3 * 9 = 27 tests in total for the triglyceride study. This is a very small sample size focused specifically on interference, not diagnostic accuracy.
  • For other interfering substances (hemoglobin, bilirubin, human serum albumin, hematocrit), the document mentions "samples containing high levels" but does not specify the exact number of distinct samples or replicates tested.
• Data Provenance: Not explicitly stated (e.g., country of origin). However, given the context of a medical device submission to the FDA, it is typically expected to be from a controlled laboratory setting. It is a retrospective analysis of prepared samples designed to evaluate interference.

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

• The document describes an interfering substance study, not a clinical study requiring expert diagnosis of H. pylori. The "ground truth" for the test set in this context refers to whether the samples were genuinely positive or negative for H. pylori, as well as the known concentration of the interfering substances.
• The ground truth (e.g., low positive, high positive, negative H. pylori samples, and known concentrations of spiked triglycerides) would have been established by laboratory methods or reference materials.
• No human experts (like radiologists) were involved in establishing the ground truth for this specific type of performance study presented.

4. Adjudication Method for the Test Set

• None directly applicable as this was not an expert review or clinical trial for diagnostic accuracy. The results were assessed against expected outcomes (positive should remain positive, negative should remain negative).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The document describes a laboratory-based interfering substance study, not a clinical study comparing human reader performance with and without AI assistance. The device itself is a rapid immunoassay, not an AI-powered diagnostic system requiring human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• While the device itself is a standalone diagnostic (a rapid immunoassay, not an algorithm in the traditional AI sense), the performance data presented is for the device's reaction to spiked samples under controlled lab conditions, not its standalone diagnostic accuracy in a clinical population. The device provides a visual result (colored lines) that is interpreted.

7. The Type of Ground Truth Used

• The ground truth used for the interfering substance study was based on known H. pylori positive/negative status of the samples (presumably established by reference methods or manufacturing standards for the "standards" used) and known spiked concentrations of interfering substances. This is a form of laboratory-controlled ground truth.

8. The Sample Size for the Training Set

• The document does not mention a training set in the context of machine learning or AI. This device is a lateral flow immunoassay, which does not typically involve "training data" in the AI sense for its core function. Its design and performance are based on biochemical interactions.

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

• Not applicable as there is no mention of a training set for an algorithm.

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The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.

• 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 of patients 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, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

The Alere Cholestech LDX® System is a small, portable analyzer and test cassette system is for in vitro diagnostic use only. The Lipid Profile GLU Cassette is for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides and glucose in whole blood. A TC/HDL (total cholesterol/HDL cholesterol ratio and estimated values for LDL (low-density lipoprotein) and non-HDL cholesterol are calculated by the Alere Cholestech LDX® Analyzer.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes acceptability based on substantial equivalence to an earlier version of the device, primarily focusing on the impact of a software upgrade that incorporates a humidity sensor. The acceptance criteria aren't explicitly stated as numerical targets in a table, but rather as demonstrating that the updated device performs equivalently to the predicate device, especially considering the correction factor applied for humidity.

The key performance aspect mentioned is that analytical results are unchanged when operated between 40% and 60% relative humidity, and that a small correction factor is applied for humidity levels between 20-40% RH and 60-80% RH. This implies that the device, after applying the correction, should produce results comparable to the predicate device across the specified humidity ranges.

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

The document mentions "Performance testing demonstrates that the software upgrade..." but does not specify the sample size used for the test set.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a submission to the FDA, suggesting a US-centric regulatory context, but detailed provenance is absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided in the document. The device is an in-vitro diagnostic system for quantitative determination of analytes (cholesterol, HDL, triglycerides, glucose), typically validated against reference methods rather than expert consensus on images or clinical assessments.

4. Adjudication Method for the Test Set:

This information is not provided. Given that this is an IVD device for quantitative measurements, adjudication in the sense of multiple experts reviewing results is unlikely to be the primary method for ground truth establishment. Instead, comparison against a reference method would be expected.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or AI tools where human readers interpret results, and the document describes an automated in-vitro diagnostic system.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone study was done. The "Performance testing" mentioned is specifically to demonstrate the performance of the device itself (analyzer + software + cassette), operating without human interpretation of the results to establish the primary measurements. The update specifically addresses the algorithm's behavior with the new humidity sensor and correction factor.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. However, for quantitative in-vitro diagnostic devices, the typical ground truth established in performance testing would involve:

• Reference Methods: Comparison of the device's quantitative results against established, highly accurate laboratory reference methods (e.g., CDC-certified reference methods for lipids and glucose).
• Traceability to Certified Standards: Ensuring the device's measurements are traceable to international or national certified reference materials and methods.

The phrase "analytical performance has been returned to its original intent" implies that the new software's results, especially after humidity correction, align with the performance previously validated against such reference methods.

8. Sample Size for the Training Set:

The document does not mention a training set in the context of machine learning or AI algorithm development. The change is described as a software revision that incorporates a humidity sensor and applies a correction factor from a "lookup table." This suggests a rule-based or empirically derived correction rather than a machine learning model that would require a distinct training set.

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

Since there is no mention of a training set in the context of machine learning, this information is not applicable and not provided. The "lookup table" for humidity correction would likely have been developed through internal testing and calibration processes, comparing device readings at various humidity levels against known, accurate values, but this is not explicitly detailed as a "training set" in the AI sense.

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Alere INRatio®2 PT/INR Monitoring System (Professional Use): The Alere INRatio®2 PT/INR Monitoring System (Professional Use), consisting of the INRatio®2 Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin on clotting time by health care professionals. The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes.

Limitations: The Alere INRatio 2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

Alere INRatio®2 PT/INR Home Monitoring System: The Alere INRatio®2 PT/INR Home Monitoring System, consisting of the INRation2 Home Monitor and INRatio®2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh capillary whole blood to monitor the effect of warfarin therapy on clotting time by properly selected suitably trained users (by prescription for home use or other order of a treating physician). Patients must be stabilized (>6 weeks) on warfarin therapy. The The Alere INRatio 2 PT/INR Home Monitoring System is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio®2 PT/INR Home Monitoring System is not intended to be used for screening purposes.

Limitations: The Alere INRatio®2 PT/INR Home Monitoring System is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.

The INRatio2 PT/INR Monitoring Systems (Professional and Home) perform a modified version of the one-stage Prothrombin Time test, using commercially available recombinant human thromboplastin (rhTP) reagent. The clot formed in the Prothrombin Time (PT) reaction is detected by a change in the electrical impedance of the sample during the coagulation process. The system consists of a monitor and disposable test strips. The monitor heats the test strip to the proper reaction temperature; a measure clot impedance and provides a result on a screen (user interface). The clotting reaction occurs on the Test Strip after the blood sample is applied. An International Normalized Ratio (INR) value is calculated from measured Prothrombin Time and the INR is displayed on the monitor to the user/patient.

The Alere INRatio2 PT/INR Monitoring System and INRatio2 PT/INR Test Strips were evaluated for performance against acceptance criteria. The study aimed to demonstrate equivalent or better performance compared to previously cleared devices.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table (pages 3-6) showing the performance of the new INRatio2 PT/INR Monitoring System utilizing the modified Alere™ INRatio2 PT/INR Test Strip against the previous INRatio/INRatio2 Monitoring PT/INR Test Systems.

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