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Lipid Controls: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.

Multianalyte Control: Assayed quality control materials for use with the Alere Cholestech LDX® system. Alere Cholestech LDX® Level 1 and Level 2 Controls are designed to be used only for monitoring the performance of test procedures on the Alere Cholestech LDX® System.

Calibration Verification: Assayed calibration verification material is designed to be used for verifying the reportable range of tests on the Alere Cholestech LDX® System. This material is designed for use with any Alere Cholestech LDX® cassette type that includes total cholesterol, HDL cholesterol, triglycerides and glucose.

Assayed Quality Control materials and Assayed Calibration Verification materials for use with the Alere Cholestech LDX® system.

The provided text describes the Alere Cholestech LDX® Lipid Controls, Multianalyte Controls, and Calibration Verification materials, but does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical trial or algorithm performance evaluation typically associated with medical imaging or AI devices.

This document is a 510(k) summary for a set of quality control materials for an existing diagnostic system (Alere Cholestech LDX® System). The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to evaluate the performance of a new diagnostic algorithm or device against a disease outcome.

Here's a breakdown of why many of your requested items cannot be answered from the provided text:

• Type of Device: The device in question is "Assayed Quality Control materials" and "Assayed Calibration Verification materials." These are reagents/consumables used to ensure an existing diagnostic system (Alere Cholestech LDX® System) is performing correctly. They are not a diagnostic device that interprets patient data or images.
• Nature of the Submission: This is a 510(k) submission focused on a change in manufacturing location and demonstrating that the newly manufactured controls are substantially equivalent to the previously manufactured controls. It explicitly states: "Streck has transferred the responsibility for manufacturing the controls from the Streck manufacturing site (Omaha, Nebraska) to the Alere manufacturing site (San Diego, California). All raw materials, vendors, raw material specifications, generic manufacturing processes, in-process test methods, final release test methods, release specifications and methods of value assignment are unchanged."

Therefore, the information regarding acceptance criteria for diagnostic accuracy, sample sizes for test/training sets, expert consensus, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance against disease outcomes is not relevant to this submission and thus not present in the document.

However, I can extract information related to the substantial equivalence claim, which is the core of this document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics typically applied to diagnostic devices for patient outcomes. Instead, the acceptance is based on "substantial equivalence" to a predicate device for quality control materials.

Note: The "reported device performance" is a summary statement asserting substantial equivalence, not specific numerical results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for a "test set" in the context of evaluating a diagnostic algorithm. It mentions "Bench performance testing was performed comparing the new device and the predicate device," but provides no specifics on the number of samples, analytes, or origin of these samples. Given it's quality control material, the "samples" would be aliquots of the control material itself, run on the Cholestech LDX® system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept is not applicable to the submitted device. There is no "ground truth" established by experts in the context of diagnostic interpretation, as this device consists of quality control materials. The "ground truth" for quality control materials would be their assigned target values, which are established through certified reference methods or robust internal validation processes (not described in detail here beyond "methods of value assignment are unchanged").

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in diagnostic studies to resolve discrepancies among multiple expert readers. This is not relevant for quality control materials.

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

Not applicable. This device is not an AI diagnostic algorithm; it is quality control material for an existing diagnostic system. An MRMC study is therefore not relevant.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. As noted in point 3, the concept of a diagnostic "ground truth" (like pathology or outcomes data) is not relevant for quality control materials. The "ground truth" for controls relates to their assayed values.

8. The sample size for the training set

Not applicable. Quality control materials do not involve a "training set" in the AI or machine learning sense.

9. How the ground truth for the training set was established

Not applicable. See point 8. The document states that "methods of value assignment are unchanged," indicating that the established procedures for determining the values of the control materials remain the same as for the predicate device.

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The INRatio/INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio/INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use). The INRatio2 PT Monitoring system is intended for professional and home use by people taking warfarin and other oral anticoaqulant (blood thinning) therapy who need to monitor the of their blood. The INRatio/INRatio2 PT Monitoring system is not intended to be used for screening purposes.

The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time 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 measures impedance, heats the test strip to the proper reaction temperature, and provides a user interface. The blood sample is applied to the Test Strip and the clotting reaction occurs on the Test Strip.

The provided 510(k) summary for the INRatio/INRatio2 Test Strips focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical performance testing. It explicitly states that no clinical data was presented or performed for this submission. Therefore, the information requested in the prompt regarding acceptance criteria, clinical study details, sample sizes for test/training sets, expert involvement, and ground truth establishment primarily relates to clinical studies, which are absent in this submission.

However, based on the provided text, I can extract information about the non-clinical performance testing and the basis for the substantial equivalence determination.

Here's the breakdown of what can be answered and what cannot:

1. A table of acceptance criteria and the reported device performance:

Since no clinical data is presented, there are no specific clinical acceptance criteria or reported clinical performance metrics in this document. The document refers to non-clinical performance testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided in the document. The document only mentions "Performance testing" without specifying sample sizes for the non-clinical tests or their provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. This question pertains to clinical studies and expert review for ground truth, which were not part of this submission by explicit statement.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not provided. This question pertains to clinical studies and ground truth establishment, which were not part of this submission.

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:

Not applicable. This device is a Prothrombin Time (PT) monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers.

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

Not applicable. This question typically applies to AI algorithms. This device is a PT monitoring system (monitor + test strips), which measures PT directly. Its performance is inherent in the device itself, not an algorithm's interpretation of human-generated data.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not provided for non-clinical testing. For the non-clinical performance, the "ground truth" would be established by reference methods or validated laboratory techniques for precision, accuracy, sensitivity, etc., but the specific methodologies are not detailed in this summary.

8. The sample size for the training set:

Not applicable/Not provided. This refers to machine learning algorithms, which are not explicitly mentioned or the focus of this submission. "Training set" typically refers to data used to train an AI model.

9. How the ground truth for the training set was established:

Not applicable/Not provided. As with point 8, this refers to machine learning algorithms.

Summary of Study (Based on Provided Text):

The study was a non-clinical performance comparison of the modified INRatio/INRatio2 Test Strips against the previously cleared INRatio Test Strips (predicate device, K072727).

• Objective: To verify that the modified INRatio2 Test Strips have equivalent or better performance compared to the predicate device.
• Methodology: Performance testing was conducted to evaluate "within-day precision, accuracy, heparin sensitivity, factor sensitivity, and potential interferents."
• Results: The testing "verified that the modified INRatio2 Test Strips have equivalent or better performance" across all assessed parameters.
• Conclusion: Based on this non-clinical data, the INRatio2 Test Strips were deemed substantially equivalent to the predicate device.
• Clinical Data: No clinical validation testing was performed for this submission, as explicitly stated and as per discussions with the reviewer. This implies the substantial equivalence was primarily based on the non-clinical performance data demonstrating that the modifications did not alter the fundamental performance characteristics beyond what was previously cleared.

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The One Step EDDP (Methadone Metabolite) Test Strip is a rapid immunochromatographic assay for the qualitative detection of 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine (EDDP), an inactive metabolite of methadone, at a designated cutoff concentration of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use and professionals at point of care sites.

This assay provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

The One Step EDDP (Methadone Metabolite) Test is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. EDDP, if present in the urine specimen below 300 ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized EDDP conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the EDDP level exceeds 300 ng/mL because it will saturate all the binding sites of anti-EDDP antibodies. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region. This confirms sufficient specimen volume, adequate membrane wicking and correct

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical targets. Instead, the "Accuracy" and "Analytical Sensitivity" sections describe the performance that was evaluated and found acceptable. The "Overall Agreement with GC/MS Analysis" of 98% is the primary performance metric for accuracy.

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

• Sample Size for Accuracy Study (Clinical Study): 549 specimens across three clinical sites (183 specimens per site).
• Sample Size for Analytical Sensitivity Study (Spiked Samples): 630 tests (90 tests at each of 7 different EDDP concentrations).
• Data Provenance: The text does not specify the country of origin of the data. The clinical study was performed at "three external clinical study sites," suggesting prospective collection for the purpose of this evaluation. The analytical sensitivity study used "drug-free urine pool[s] spiked with EDDP," indicating laboratory-controlled, prospective data generation.

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

• Number of Experts: The document states that the testing for the accuracy study was performed by "3 different employees performing the testing" at the clinical sites for the One Step EDDP Test Strip. However, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the "experts" in this context would be the technicians or analysts operating the GC/MS.
• Qualifications of Experts: The document does not specify the qualifications of the personnel operating the GC/MS.

4. Adjudication Method for the Test Set

• The document implies a direct comparison of the One Step EDDP Test Strip results to the GC/MS results. There is no mention of an "adjudication method" involving multiple human readers for either the test device results or the GC/MS results. The GC/MS is presented as the reference method ("preferred confirmatory method"), suggesting its results were considered definitive for ground truth.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a diagnostic test strip, not an AI-assisted diagnostic tool for interpretation by human readers.

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

• Yes, the performance data presented is for the "One Step EDDP (Methadone Metabolite) Test Strip" itself, without human interpretation influencing the reported accuracy against GC/MS. The test is designed to provide a "visual, qualitative result," which is then compared to the GC/MS. While a human reads the test strip, the reported accuracy reflects the strip's ability to correctly indicate the presence or absence of EDDP at the cutoff, rather than a human's ability to interpret complex images or data. The "Analytical Sensitivity" section, especially with spiked samples, is a clear standalone performance evaluation.

7. The Type of Ground Truth Used

• The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. GC/MS is described as the "preferred confirmatory method" and the "reference method" against which the device's accuracy was compared.

8. The Sample Size for the Training Set

• The document does not provide details on a separate "training set" or its sample size. This type of immunoassay device typically does not involve a machine learning algorithm that requires a "training set" in the conventional sense. Its performance is based on the chemical and immunological properties built into the strip. The studies described are for validation/testing.

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

• As there's no mention of a traditional "training set" for a machine learning algorithm, this question is not applicable. The device's performance is inherently linked to its design and manufacturing specifications.

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The Triage® Total 3 Controls are assayed controls to be used with the Triage® Troponin I Test. Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Calibration Verification are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

The Triage® Total 3 Controls and the Triage® Total 3 Calibration Verification Set are quality control materials that contain CKMB, cardiac troponin I, and BNP at multiple concentrations. These materials are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate the Triage® tests. The results of quality control testing do not impact direct patient care and should not influence clinical decision making process the physician uses to make clinical diagnosis for the patient.

This submission describes Triage® Total 3 Controls and Triage® Total 3 Calibration Verification Set, which are assayed quality control materials used to monitor the performance of specific Triage® tests (Troponin I, BNP, Cardio2 Panel, Cardio3 Panel) and the Triage® Meter. The device is being compared to a predicate device, the Triage® Total 5 Controls and Calibration Verification Set.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the new device. Instead, it relies on demonstrating "substantial equivalence" to a predicate device through "performance testing." The key performance characteristic mentioned is "value assignment and stability."

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

The document does not provide specific details on the sample size used for the performance testing. It generally refers to "bench performance testing."

It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). Given that it's a Triage® product, the test is likely performed in clinical laboratories, which could be in the US or other regions where Triage® products are used. The testing described appears to be laboratory-based ("bench performance testing") rather than patient-based.

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

Given that this device is a quality control material, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologists interpreting images) is not applicable. The "ground truth" in this context would be the accurately determined concentrations of the analytes (CKMB, cardiac troponin I, and BNP) within the control materials. These values are established through rigorous analytical methods and reference standards, not human expert consensus. The document does not specify the number or qualifications of experts involved in this process, as it falls under standard quality control manufacturing practices.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for quality control materials is established through analytical validation and reference methods, not human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a quality control material for in vitro diagnostic tests, not an AI or imaging device that would involve human readers. Therefore, an MRMC study is not relevant.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-loop Performance)

Yes. The performance testing described (value assignment and stability) represents standalone performance of the control materials in conjunction with the Triage® meter/assays, without direct human intervention in the "performance" aspect itself beyond standard laboratory procedures for running controls. The device's function is to objectively monitor the performance of other diagnostic tests.

7. Type of Ground Truth Used

The "ground truth" for this type of device would be the analytically determined concentrations of the target analytes (CKMB, cardiac troponin I, and BNP) within the control materials, established through validated reference methods and traceable standards. The document doesn't explicitly detail the methodology for establishing these values but implies they are part of the "value assignment" process.

8. Sample Size for the Training Set

Not applicable. This device is a quality control material and not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of such a device involves the manufacturing process and analytical validation.

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

Not applicable, as there is no "training set" for this type of device. The "ground truth" (i.e., the target values) for such quality control materials are established during their development and manufacturing through precise analytical methods.

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