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The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.

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The provided document is a 510(k) premarket notification letter from the FDA to CLINIQA CORPORATION regarding their i-STAT PT Control and i-STAT ACT Control devices. This type of document declares substantial equivalence to a legally marketed predicate device, primarily focusing on regulatory compliance and the device's intended use (quality control for other in vitro diagnostic devices). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for a novel diagnostic device's performance claims.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory approval letter, not a performance study report.

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Cliniqa Beta HCG Controls, Levels 1, 2, and 3 and Cliniqa Beta HCG Calibration Verification Controls, Levels 1, 2, and 3 are assayed quality control materials used to monitor the precision of Beta HCG assays.

Cliniqa Beta HCG Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Control a ready-to-use liguid control requiring no reconstitution or frozen storage.

Cliniqa Beta HCG Calibration Verification Control is prepared from human serum and purified human antigens. Preservatives and stabilizers have been added to maintain product integrity. CLINIQA Beta HCG Calibration Verification Control a ready-to-use liquid control requiring no reconstitution or frozen storage.

Here's an analysis of the acceptance criteria and study information for the Cliniqa Beta HCG Control and Cliniqa Beta HCG Calibration Verification Control, based on the provided text:

Based on the provided K121237 510(k) summary, the device is a Quality Control Material (Assayed and Unassayed) for Beta HCG assays, not a diagnostic algorithm or image analysis device. Therefore, many of the typical acceptance criteria and study aspects you've asked about (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this type of device submission.

The submission focuses on the performance characteristics relevant to a quality control material, primarily value assignment and stability.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device as a quality control material, the "acceptance criteria" are implied by the successful establishment of value assignment and stability claims.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a numerical sample size in the context of typical "test set" for a diagnostic algorithm. For value assignment, it mentions "analysis of vials representative of the entire lot." For stability, it refers to "real-time and accelerated stability tests" and "real-time testing." The number of vials or measurements
  is not detailed.
• Data Provenance: Not specified as country of origin. The "participating laboratory data" for value assignment suggests multi-site input, but locations are not given. The traceability to NIBSC is an international standard.
• Retrospective or Prospective: Stability studies are typically prospective (real-time testing) and the accelerated tests are also designed to predict future stability. Value assignment would be done concurrently for each lot.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable to this device type. This is a quality control material where "ground truth" refers to the established values and stability claims, primarily determined through laboratory testing and reference to international standards.

4. Adjudication method for the test set

Not applicable. The "ground truth" for this device is based on analytical measurements and adherence to established scientific and manufacturing practices for quality control materials, not expert consensus on interpretations.

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 quality control material, not an AI-powered diagnostic tool requiring human reader studies.

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

Not applicable. This is a quality control material, not an algorithm.

7. The type of ground truth used

The "ground truth" for this product type is established through:

• Analytical Measurement: The mean and expected range for each lot are determined by averaging raw data obtained for each method using specific reagents and calibrators.
• Traceability to International Standards: The calibration of the Roche Elecsys HCG plus Beta reagent (used for value assignment) is standardized against the 4th International Standard for Chorionic Gonadotropin from NIBSC (code 75/589).
• Validated Stability Protocols: Real-time and accelerated stability study protocols determine the shelf-life and open-vial claims.

8. The sample size for the training set

Not applicable. This is a quality control material, not an algorithm that requires a training set.

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

Not applicable, as there is no "training set."

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CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the assaycu, liquid, quality control procuments an analytes listed in the product insert.

assayed, liquid, quality control products

The provided text is a 510(k) premarket notification letter from the FDA regarding the CLINIQA® Liquid QC™ Immunoassay Control. It confirms substantial equivalence to a predicate device and outlines regulatory compliance. However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily an FDA clearance letter and lacks the technical details of a device study.

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CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures

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I am sorry, but based on the provided text, I cannot provide the requested information. The document is a 510(k) clearance letter from the FDA for CLINIQA Liquid QC Urinalysis Controls, Levels 1 and 2. It confirms that the device has been found substantially equivalent to a predicate device but does not contain any details about acceptance criteria, study design, reported device performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

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CLINIQA® Liquid QC™ Urine Chemistry Controls, Levels 1 and 2 are intended for use as an assayed quality control material. It is not intended for use as a standard. Assay values for analytes listed in this product insert are provided for both levels.

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I am sorry but this document does not contain the information you are looking for. This is a 510(k) premarket notification letter from the FDA to Cliniqa Corporation regarding their Liquid QC Urine Chemistry Controls. It confirms the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth information.

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CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for uroud a standard.

LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the reportable range.

CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liguid QC Complete Cardiac Marker Control is not intended for use as a standard.

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This document is an FDA 510(k) clearance letter for three medical devices: "Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1, 2, and 3", "Cliniqa LiniCal Cardiac Marker Calibration Verifiers, Levels A-D", and "Cliniqa Liquid QC Cardiac Marker Control-Low".

The letter states that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices, allowing them to be marketed. However, the document does not contain information regarding acceptance criteria, study details, or performance data. It is a regulatory clearance document, not a study report.

Therefore, I cannot extract the requested information about acceptance criteria and the study that proves the device meets them from the provided text. The document is primarily focused on the regulatory approval for marketing the devices as quality control and calibration verification materials for cardiac markers.

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CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.

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I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for "Cliniqa Liquid QC Assayed and Unassayed General Chemistry Control Levels 1, 2 & 3." It confirms that the device is substantially equivalent to legally marketed predicate devices.

While it mentions "indications for use," it does not include details about:

• Specific acceptance criteria (table form or otherwise)
• Reported device performance metrics
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies or effect sizes
• Standalone algorithm performance
• Types of ground truth used or how ground truth was established

This document is a regulatory approval notice, not a study report detailing performance data.

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CLINIQA Liquid QC Cardiac Marker Control SP, Levels 1, 2, & 3 are intended for use as assayed quality control material for CK-MB, hs-CRP, Digoxin, Myoglobin, cTnl, Troponin T, and NT ProBNP analysis.

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This document is an FDA 510(k) clearance letter for a medical device called "CLINIQA Liquid QC™ Cardiac Marker Control SP Levels 1, 2, & 3". It grants permission to market the device based on its substantial equivalence to a predicate device.

However, this letter does not contain information about the acceptance criteria and the study that proves the device meets those criteria, nor any of the specific details requested in the bullet points (sample sizes, expert qualifications, adjudication methods, multi-reader studies, standalone performance, ground truth types, or training set details).

The letter simply states that the device is "intended for use as assayed quality control material for CK-MB, hs-CRP, Digoxin, Myoglobin, cTnl, Troponin T, and NT ProBNP analysis." It does not provide any performance data or study results to elaborate on how this intended use is achieved or how the device's accuracy or effectiveness was evaluated.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study based on the provided text. The document is an administrative clearance, not a performance study report.

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CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis.

CLINIQA LiniCAL Lipid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU Systems for Cholesterol (total), High Density Lipoprotein. Low Density Lipoprotein and Triglyceride at five useful concentrations.

CLINIQA QALIBRATE™ - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.

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Here's an analysis of the provided text regarding the acceptance criteria and study for the CLINIQA® Liquid QC™ Lipid Controls, CLINIQA® LiniCAL® Lipid Calibration Verifiers, and CLINIQA® QALIBRATE™ - Lipid Calibrator.

It's important to note that the provided document is a 510(k) clearance letter from the FDA. This letter confirms that the devices are "substantially equivalent" to legally marketed predicate devices, meaning they have similar technology and intended use, and are deemed safe and effective. However, this document does not contain the detailed study report or specific acceptance criteria and performance data in the format typically used for AI/ML device evaluations. It primarily focuses on regulatory approval based on the substantial equivalence principle.

Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect sizes, etc.) is not present in this regulatory letter.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly stated in the provided document. The 510(k) letter confirms that the devices are substantially equivalent to predicate devices, implying that their performance aligns with acceptable standards for their intended use. However, the specific quantitative acceptance criteria (e.g., precision, accuracy ranges) and the detailed study results meeting those criteria are not provided.

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

This information is not available in the provided document. The 510(k) letter does not detail the specific studies (e.g., analytical performance studies) used to demonstrate substantial equivalence, nor does it specify the sample sizes or data provenance.

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

This information is not applicable/not available. These devices are "Calibrators" and "Quality Controls" for laboratory assays (Apolipoprotein A-1, Apolipoprotein B, Cholesterol, HDL, LDL, Triglyceride). The "ground truth" for such devices typically refers to their assigned values, which are established through rigorous analytical methods using reference materials and validated measurement procedures, not through expert consensus in the way a diagnostic imaging AI would. Therefore, the concept of "experts establishing ground truth" in this context is different and not described in the letter.

4. Adjudication Method for the Test Set:

This information is not applicable/not available for the reasons stated above in point 3.

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:

This information is not applicable and not available. These devices are not AI/ML algorithms designed to assist human readers in interpreting medical images or data. They are in-vitro diagnostic products for calibrating and controlling laboratory assays. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to these products.

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

This information is not applicable and not available. These are not AI/ML algorithms, so the concept of standalone performance does not apply. Their performance is assessed through analytical validation studies (e.g., accuracy, precision, linearity) in a laboratory setting.

7. The Type of Ground Truth Used:

For these types of devices (calibrators and quality controls), the "ground truth" generally refers to:

• Assigned Values: The known, predetermined concentration or activity of the analytes within the calibrator or control solutions. These values are established by the manufacturer using highly accurate and precise reference methods, often traceable to international reference materials.
• Reference Methods: The established, gold-standard laboratory methods used to determine the assigned values of the control and calibrator materials.

The document does not detail how Cliniqa established these assigned values, but it's implicit that they followed standard practices for in vitro diagnostic product manufacturing and validation.

8. The Sample Size for the Training Set:

This information is not applicable/not available. These products are not AI/ML models that require "training sets." They are reagents with specific chemical compositions and assigned values.

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

This information is not applicable/not available for the reasons stated in point 8.

Summary regarding the provided document:

The provided FDA 510(k) clearance letter serves as regulatory approval, indicating that the CLINIQA® Lipid products are substantially equivalent to existing marketed devices. It does not present a detailed study report with the specific performance acceptance criteria or study results that would typically be required for an AI/ML device. The nature of these devices (calibrators and quality controls) is fundamentally different from AI/ML diagnostic tools, hence many of the requested categories are not applicable.

To obtain the detailed performance data, one would typically need to refer to:

• The manufacturer's specific product inserts.
• Validation reports submitted to the FDA (which are not publicly detailed in the 510(k) summary letter).
• Peer-reviewed publications or internal validation studies conducted by the manufacturer.

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CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided.

CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided.

CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers .

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The provided document is a 510(k) premarket notification letter from the FDA for CLINIQA Dry QC™ Chemistry Control and CLINIQA QUALIBRATE™- CH Chemistry Calibrator. This letter grants substantial equivalence, allowing the devices to be marketed. However, it does not contain any information regarding the acceptance criteria, specific performance study details, or ground truth establishment for these devices.

The document is purely an administrative notification of regulatory clearance based on substantial equivalence to a predicate device, and thus does not include the detailed technical study information requested in your prompt.

Therefore, I cannot provide the requested information.

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