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For the quantitative determination of creatine kinase activity in serum and plasma. Rx only.

Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infaction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

The Pointe Scientific Creatine Kinase (CK) Reagent Set consists of ready-to-use liguid reagents:

• . CK R1 (buffer) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L; NADP 2.0 mmol/L: HK (Baker's yeast) 2.5 KU/L: Glucose 20.0 mmol/L: Magnesium Acetate 10.0 mmol/L; EDTA 2.0 mmol/L and N-acetylcysteine (NAC) 20.0 mmol/L.
• . CK R2 (enzyme reagent) contains: Imidazole buffer (pH 6.7) 100.0 mmol/L: ADP 2.0 mmol/L: AMP 5.0 mmol/L: Diadensosine pentaphosphate 10.0 mmol/L: Creatine phosphate 30.0 mmol/L; G6PDH (Baker's yeast) 1.5 KU/L and EDTA 2.0 mmol/L.

The kinetic procedure presented is a modification of Szasz of the Rosalki technique, which optimizes the reaction by reactivation of CK activity with N-actyl-L-cysteine (NAC).

Creatine Kinase specifically catalyzes the transphosphorylation of ADP to ATP. Through a series of coupled enzymatic reactions, NADPH is produced at a rate directly proportional to the CK activity. The method determines the NADPH absorbance increase per min at 340 nm.

The provided document describes the analytical performance studies for the Pointe Scientific Creatine Kinase (CK) Reagent Set, which supports its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study details:

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

The document doesn't explicitly state "acceptance criteria" in a separate table for each test. Instead, it presents the study results and implies that these results were considered acceptable for demonstrating substantial equivalence. For some tests, like Linearity, an acceptable deviation is stated.

However, based on the provided performance data, we can infer the acceptance criteria that the manufacturer likely aimed for to support their claims.

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

• Method Comparison (Serum):
  • Sample Size: 120 de-identified remnant serum samples. 4 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified, but likely within the US given the FDA submission.
• Method Comparison (Plasma):
  • Sample Size: 123 de-identified remnant plasma samples. 2 samples were altered by mixing.
  • Data Provenance: Obtained from a commercial repository. Retrospective. Country of origin not specified.
• Precision Studies:
  • Sample Size: 2 commercial quality controls, 3 serum pools, and 3 plasma pools. Each pool/control was tested in duplicate twice per day for 20 days (n=80 per sample type).
  • Data Provenance: Not explicitly stated, but common practice is for manufacturers to prepare pools or use commercially available controls.
• Linearity/Assay Range Study:
  • Sample Size: A set of 12 serum samples and 12 plasma samples (prepared by admixture of high-level and low-level pools).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Detection Capability (LoB, LoD, LoQ):
  • LoB: Saline (1 sample * 20 repetitions * 3 days).
  • LoD: 20 low-level depleted serum samples and 20 depleted plasma samples.
  • LoQ: 5 low activity samples (each run in 8 duplicates over 5 days).
  • Data Provenance: Not explicitly stated, likely prepared in-house or from common available resources.
• Dilution Recovery Studies:
  • Sample Size: Three contrived high-level samples for both serum and plasma.
  • Data Provenance: Not explicitly stated, likely prepared in-house.
• Analytical Specificity (Endogenous Substances):
  • Sample Size: Not explicitly stated, but interference testing was conducted using "randomly selected serum and plasma samples ranging from 43 U/L to 268 U/L."
  • Data Provenance: Not explicitly stated.

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

This is a diagnostic reagent for quantitative determination of an analyte (Creatine Kinase), not an imaging or qualitative diagnostic device requiring expert interpretation of results to establish ground truth.

• Ground Truth for Method Comparison: The predicate device's results (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) serve as the "reference" or "ground truth" for comparison. This is a common method for demonstrating substantial equivalence for in vitro diagnostic (IVD) devices. No human experts are used to establish ground truth in this context; rather, the established method of the predicate device is the reference.
• Ground Truth for other studies (Precision, Linearity, Detection, Dilution Recovery, Specificity): The "ground truth" is typically established by the analytical method itself, or by preparing samples with known concentrations/characteristics, without the need for human expert consensus.

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

No adjudication method is relevant or mentioned as this device measures an objective biochemical marker. The 'ground truth' is the quantitative measurement itself or the reference method's result.

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:

No. This is not applicable. The device is a diagnostic reagent for quantitative measurement of creatine kinase, not an AI-powered diagnostic system for image interpretation or a device requiring human readers/scorers. Therefore, MRMC studies are not relevant.

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

The device is a reagent set used on an automated chemistry analyzer (Shenzhen Mindray BA-800M Chemistry Analyzer). The performance studies presented are for the "algorithm only" in the sense that they demonstrate the analytical performance of the reagent on the analyzer without human interpretation of the raw data to generate the numerical result. The "human-in-the-loop" would be a lab technician performing the test and reviewing the results, but the analytical performance itself is standalone.

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

• Method Comparison: The results obtained from the legally marketed predicate device (Beckman Coulter Creatine Kinase (CK-Nac) on the Beckman Coulter Olympus AU400 Clinical Chemistry Analyzer) served as the reference for comparison.
• Precision, Linearity, Detection, Dilution Recovery, Analytical Specificity: Ground truth is based on the inherent analytical properties of the method/reagent including samples with known concentrations (e.g., prepared standards, spiked samples, qualified controls, or established reference material). Linearity was assessed against expected values based on known admixtures. Detection limits were determined using statistical methods on low-level and blank samples.

8. The sample size for the training set:

There is no "training set" in the context of this 510(k) submission for a diagnostic reagent. This device is not an AI/machine learning algorithm that requires training data. The studies performed are analytical validation studies.

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

Not applicable, as there is no training set for this type of medical device.

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For the in vitro quantitative measurement of creatine kinase activity in serum and plasma on the SK500 Clinical Chemistry System. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The SEKURE Creatine Kinase Assay (CK Assay) is a spectrophotometric, coupled enzyme assay for the quantitative measurement of creatine kinase (CK) activity. The assay consists of two working reagents, a buffer solution (R1) and a substrate reagent (R2). The SEKURE CK Assay employs the reverse reaction of CK, to produce adenosine triphosphate (ATP). The reaction is coupled to hexokinase and G6PDH which consumes ATP to generate NADPH. The rate of NADPH formation is monitored at 340 nm and is directly proportional to CK activity. Testing is performed on the SK500 in conjunction with calibrator and controls which are provided separately.

The SK500 Analyzer is manufactured as Clinical Chemistry Analyzer Tokyo Boeki Medisys Inc. Biolis 50i Superior. "SK500" is the Sekisui Diagnostics labelled name for the Tokyo Boeki Medisys Inc. Biolis 50i Superior instrument.

This document describes the SEKURE Creatine Kinase Assay, an in vitro diagnostic device, and its performance study to demonstrate substantial equivalence to a predicate device.

1. Acceptance Criteria and Reported Device Performance

The device performance is evaluated against various analytical metrics. While explicit "acceptance criteria" for each study are not individually listed as pass/fail thresholds in a table, the document reports the results of these studies, implying that the observed performance met internal or regulatory expectations for demonstrating substantial equivalence. The predicate device's characteristics serve as an implicit benchmark for similarity.

Here's a table summarizing the reported device performance, with implied acceptance based on the submission being cleared:

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ADVIA Chemistry® Creatine Kinase (CK_L) Assay:

The ADVIA Chemistry® Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma (lithium heparin) or serum on ADVIA Chemistry systems. The assay can be used to aid in the diagnosis and treatment of myocardial infarction and muscle diseases, such as Duchenne progressive muscular dystrophy.

ADVIA Chemistry® Enzyme 3 Calibrator:

ADVIA Chemistry® Enzyme 3 Calibrator is intended for in vitro diagnostic use in the calibration of the ADVIA Chemistry Creatine Kinase (CK L) assay on the ADVIA Chemistry systems.

ADVIA Chemistry Creatine Kinase (CK L) assay is a ready-to-use liquid reagent packaged for use on the automated ADVIA Chemistry systems. Creatine Kinase reacts with creatine phosphate and ADP to form adenosine triphosphate (ATP), which is coupled to the hexokinase-G6PD reaction, generating NADPH. The concentration of NADPH is measured by the increase in absorbance at 340/596 nm.

ADVIA Chemistry ENZ 3 CAL:

ENZ 3 CAL is a liquid frozen human serum albumin based product containing creatine kinase MM from human heart. Enzyme 3 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required).

The provided document is a 510(k) Premarket Notification for an in vitro diagnostic device, the ADVIA Chemistry® Creatine Kinase (CK L) Assay and ADVIA Chemistry® Enzyme 3 Calibrator. It describes the device's technical specifications, intended use, and performance characteristics to demonstrate substantial equivalence to a legally marketed predicate device.

However, the request asks for information relevant to the development and validation of an AI/ML-driven medical device, which typically involves acceptance criteria for model performance (e.g., accuracy, sensitivity, specificity), study design for clinical validation (e.g., test set sample size, ground truth establishment by experts, MRMC studies), and training set details.

The provided document describes the analytical validation of a chemical assay, which measures the concentration of a substance (Creatine Kinase) in human samples. Its performance is evaluated through parameters like method comparison, precision, linearity, detection capability, and interference testing. These are fundamentally different from the performance metrics and study designs used for AI/ML devices, which often involve image analysis, pattern recognition, and diagnostic classification.

Therefore, the provided text does not contain the information requested regarding acceptance criteria related to AI/ML device performance, expert adjudication, MRMC studies, or training set details typical of AI/ML model development.

I cannot create the table or answer the specific questions about an AI/ML device's acceptance criteria and study data based on the provided document. The document describes a traditional in-vitro diagnostic assay rather than an AI/ML-driven device.

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Randox Liquid CK-MB: The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola.
Randox CK-MB Calibrator: The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods.
The Randox Liquid CK-MB test system for the RX Imola is a prescription use device intended to be used in clinical laboratories only.

Liquid CK-MB is supplied in a kit containing:

• 4 x 20.0 mL CK-MB Buffer
• 4 x 6.0 mL CK-MB Substrate.
  The CK-MB calibrator is lyophilised, single analyte, human serum based product. The kit contains ten vials (single level) with 1.0 mL per vial. Double de-ionised water is required for reconstitution.

Here's a summary of the acceptance criteria and the study details for the Randox Liquid CK-MB and Randox CK-MB Calibrator, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document outlines performance characteristics rather than explicit "acceptance criteria" in a pass/fail table. However, implied acceptance is demonstrated by the reported empirical results.

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Vital Diagnostics CPK Reagent is a device intended for the in vitro quantitative determination of creatine phosphokinase activity in human serum or plasma. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Vital Diagnostics CPK Reagent

The provided text is a 510(k) clearance letter for a medical device called "Vital Diagnostics CPK Reagent". It primarily focuses on the regulatory approval of the device and its indications for use. The document does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found in clinical validation reports or performance studies.

Therefore, I cannot populate the requested information. The document is strictly a regulatory approval letter.

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The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension Vista® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension Vista® chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Dimension Vista® (CKI) Flex® Reagent Cartridge (K2038): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine-diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.

Dimension Vista® (MBI) Flex® Reagent Cartridge (K2032): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.

This document describes the 510(k) summary for the Dimension Vista® Creatine Kinase Flex® and Creatine Kinase MB Flex® Reagent Cartridges (K2038 and K2032, respectively).

Here's an analysis of the provided text to extract the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document establishes substantial equivalence by comparing the performance characteristics of the new Dimension Vista® cartridges with their predicate devices, Dimension® CKI (DF38) and MBI (DF32) Flex® Reagent Cartridges (K081731). The acceptance criteria are implicitly defined by the performance of the predicate device, and the new devices are deemed to "demonstrate substantial equivalent performance."

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

The document states, "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance." However, it does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided in the document. For in vitro diagnostic tests like these, "ground truth" is typically established by reference methods or validated laboratory results, not by human expert interpretation of images or other subjective data.

4. Adjudication method for the test set:

This information is not applicable as the "test set" in this context refers to clinical samples analyzed by the device, not data requiring expert adjudication.

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 is not applicable as the device is a reagent cartridge for an in vitro diagnostic assay, not an AI-powered diagnostic imaging tool that would involve human readers.

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

The device is inherently a "standalone" system in the sense that it performs the measurement algorithmically without a human actively interpreting its real-time output for a diagnostic decision in the same way an AI for image analysis would. The device generates quantitative results, which are then used by clinicians for diagnosis and treatment. Therefore, the performance presented is standalone performance of the reagent cartridges on the Dimension Vista® system.

7. The type of ground truth used:

The "ground truth" for evaluating these reagent cartridges would typically be established by:

• Reference methods: Highly accurate and precise laboratory methods for measuring Creatine Kinase (CK) and Creatine Kinase MB (CK-MB).
• Validated laboratory results: Measurements obtained using existing, cleared devices that are considered reliable standards.

The document implicitly refers to this by stating "comparative testing" with the predicate devices, meaning the predicate device results served as the reference for determining substantial equivalence.

8. The sample size for the training set:

This information is not provided in the document. For in vitro diagnostic reagents, there isn't a "training set" in the machine learning sense. The "development" or "optimization" phase would involve testing various formulations and conditions, but this is not typically referred to as a "training set" with explicit sample sizes in the regulatory submission summary for such devices.

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

This information is not provided and is generally not applicable in the context of traditional in vitro diagnostic reagent development in the same way it would be for an AI algorithm. The "ground truth" would be established by the rigorous chemical and enzymatic principles underlying the assay and validated against known standards and reference materials during the development and manufacturing process.

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The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.

Dimension® (CKI) Flex® Reagent Cartridge (DF38): In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting qlucose-6-phosphate is oxidized by qlucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.

Dimension® (MBI) Flex® Reagent Cartridge (DF32): The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose_The resulting glucose-6-phosphate is oxidized by glucose-6phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.

CKI/MBI Calibrator (DC32): CKI/MBI CAL is a liquid, multi-analyte, human serum albumin based product containing creatine kinase (human source) and creatine kinase MB (porcine source). The kit consists of four vials per level (2 and3) with 2.0 mL per vial. Level 1 calibrator for CKI/MBI is not included in the CKI/MBI CAL carton. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension® Creatine Kinase MB Flex® Reagent Cartridge (DF32) and CKI/MBI Calibrator (DC32):

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" with numerical targets for performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance is implied by the comparison tables, showing that the new devices perform comparably to the predicates in terms of intended use, technology, measuring range, and analytical sensitivity.

Without explicit acceptance criteria, we can infer the reported device performance from the comparison to the predicate devices.

For CKI (DF38):

For CKI/MBI Calibrator (DC32):

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

The summary states: "Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance."

• Sample Size: The document does not specify the sample size used for the comparative testing (test set patients or samples).
• Data Provenance: The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the samples). It only mentions "human serum and plasma" as sample types.

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

This information is not applicable as the devices are in vitro diagnostic reagents and calibrators designed for quantitative laboratory measurement, not for interpretation by human experts. The "ground truth" in this context would be the measured values from the predicate devices or reference methods. The performance is assessed by analytical comparison, not expert consensus on diagnoses.

4. Adjudication Method for the Test Set

This is not applicable to this type of in vitro diagnostic device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human readers interpret medical images or conduct clinical assessments, and disagreements need resolution. For laboratory assays, performance is assessed through statistical methods comparing results to a reference.

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 is not applicable. This submission concerns in vitro diagnostic reagents and calibrators, not an AI-assisted diagnostic tool that would involve human readers interpreting results. Therefore, an MRMC study and AI-assisted performance improvement are not relevant to this submission.

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

This is not applicable. The device is an in vitro diagnostic reagent system that functions on a clinical chemistry analyzer. It is an algorithm-driven system in the sense that the analyzer's software processes the photometric measurements, but it's not a standalone "algorithm" in the context of AI or image interpretation. Its performance is its standalone performance on the Dimension® system, generating quantitative results. The comparison is made against existing predicate assays.

7. The Type of Ground Truth Used

The "ground truth" for proving substantial equivalence in this context is the results obtained from the legally marketed predicate devices (Roche CK-NAC Reagent, Roche CK-MB Reagent, and their respective calibrators). The comparative testing would involve analyzing samples with both the new device and the predicate to show similar results.

8. The Sample Size for the Training Set

This information is not applicable in the context of this submission. "Training set" typically refers to data used to train a machine learning model. These are chemical reagents and calibrators, whose performance is based on established biochemical reactions, not on data-driven machine learning models. Performance is validated through analytical studies, not an AI training process.

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

This information is not applicable for the same reasons as point 8.

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The Teco Diagnostics Creatine Kinase liquid reagent is intended for in vitro diagnostic test for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Creatine Kinase Liquid Reagent (Kinetic Method)

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"1. A table of acceptance criteria and the reported device performance": null,
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": null,
"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)": null,
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": null,
"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": null,
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": null,
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": null,
"8. The sample size for the training set": null,
"9. How the ground truth for the training set was established": null
}

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Cardiac Markers reagents, with associated calibrators and controls, are intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer to measure cardiac marker analytes.

ABX PENTRA CK-NAC CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of the total creatine kinase in human serum and plasma based on an optimized UV test.

Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive. Duchenne-type muscular dystrophy.

The ABX PENTRA CK Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA CK-MB RTU and ABX PENTRA CK-NAC methods.

ABX PENTRA Myoglobin CP reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of myoqlobin (an oxygen storage protein found in muscle) in human serum and plasma based on a latex-enhanced immunoturbidimetric assay.

Measurements of myoglobin aids in the rapid diagnosis of heart or renal disease.

The ABX PENTRA Myoglobin Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA Myoglobin CP method on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA Immuno II Control L/H is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA Multical is a calibrator for use in the calibration of quantitative Horiba ABX methods on Horiba ABX clinical chemistry analyzers.

The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision.

The ABX PENTRA P Control is for use in quality control by monitoring accuracy and precision.

All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.

The ABX PENTRA CK NAC CP is an in vitro diagnostic assay for the quantitative determination of total creatine kinase in human serum and plasma based on an optimized UV test. The assay is composed of a bi-reagent cassette, with 26 ml and 6.5 ml compartments. Reagents are chemical solutions with additives.

The ABX PENTRA Myoglobin CP is an in vitro diagnostic assay for the quantitative determination of myoglobin in human serum and plasma based on a latex-enhanced immunoturbidimetric test. The assay is composed of a bi-reagent cassette, with 15 ml and 9.5 ml compartments. Reagents are chemical solutions with chemical additives and substances of animal origin.

The ABX PENTRA Myoglobin Cal is a liquid calibrator prepared from a dilution of purified myoglobin positive human sera. It is used for the calibration of the myoglobin assay. The assigned values are given on the vials. This calibrator is provided in five vials of 1 ml.

The ABX PENTRA CK Control is a lyophilized assayed control prepared from a bovine serum albumin with chemical additives and material of biological origin. It has to be used for the quality control of the creatine kinase assay. The assigned values are given in the enclosed annex. This calibrator is provided in 4 vials of 3 ml.

The ABX PENTRA Immuno II Control L/H is a lyophilized assayed control prepared from a stabilized pool of human sera. It has 2 levels (Low and High) to be used for the quality control of the myoglobin assay. The assigned values are given in the enclosed annex. Each level of this control is provided in one vial of 3 ml.

The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. This calibrator is provided in ten vials of 3 ml.

The ABX PENTRA N Control and ABX PENTRA P Control are quality control products consisting of lyophilized human serum with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the enclosed annexes, ensuring control of the appropriate HORIBA ABX methods on the ABX PENTRA 400 analyzer. Each control is provided in ten vials of 5 ml.

This submission describes various reagents, controls, and calibrators for in vitro diagnostic use with the Horiba ABX Pentra 400 clinical chemistry analyzer. The performance data focuses on establishing substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily performance characteristics of the various reagents, controls, and calibrators.

ABX PENTRA CK NAC CP (Reagent for Total Creatine Kinase)

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