Search Results

The Creatine Kinase-MB assay is an in-vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit (CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.

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 assay is a two reagent assay for the quantitative determination of creatine kinase-MB (CK-MB) in human serum and plasma on automated clinical chemistry analyzers. The rate of the NADPH formation is directly proportional to the catalytic CK-MB activity. It is determined by measuring the increase in absorbance photometrically.

This document is a 510(k) summary for a medical device called "Creatine Kinase-MB" by Roche Diagnostics. It describes the device, its intended use, technological characteristics, and performance evaluation data.

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

Key Takeaway: This document is about a clinical chemistry assay (an in-vitro diagnostic test), not an AI/ML device. Therefore, many of the typical AI/ML study components (like multi-reader multi-case studies, expert adjudication, or separate training/test sets for AI models) are not applicable to this type of device. The "ground truth" here is the reference measurement method or the expected concentration of the analyte.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in-vitro diagnostic test and not an AI/ML device, the acceptance criteria are not typically expressed as sensitivity/specificity in an MRMC study for diagnostic imaging. Instead, the acceptance criteria relate to analytical performance characteristics. The document presents the performance data against established analytical standards (CLSI guidelines) and comparisons to a predicate device.

Study Details:

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

• Precision (Repeatability & Intermediate Precision):
  • 5 human serum samples and 2 control samples.
  • Measurements: Two aliquots per run, two runs per day for ≥ 21 days on the same analyzer using 3 lots of reagent.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory-based prospective testing as per CLSI guidelines.
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: One analyte-free sample. Measured with three lots, 10-fold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoD: Five samples with low analyte concentration. Measured with three lots, twofold determination in 6 runs, over 3 days (60 measurements per lot).
  • LoQ: 5 human serum samples diluted to low levels. Tested in 5 replicates per sample on 5 days, one run per day.
  • Data Provenance: Implies laboratory-based prospective testing as per CLSI guidelines.
• Linearity:
  • One serum pool and one plasma pool, diluted to 16 (serum) and 18 (plasma) concentrations.
  • Measurements: Measured in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Endogenous Interferences:
  • Pooled human serum samples spiked with varying levels of interferent.
  • Measurements: Tested in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Exogenous Interferences (Drugs):
  • Two sample pools (low and high CKMB concentration).
  • Measurements: Aliquots spiked with drugs, determined in triplicate.
  • Data Provenance: Implies laboratory-based prospective testing.
• Method Comparison to Predicate:
  • 105 human serum samples (plus 4 spiked with CK MB rec human).
  • Data Provenance: Not explicitly stated origins of human serum samples, but implies prospective collection for this comparison.
• Matrix Comparison (Anticoagulants):
  • 31 Li Heparin tubes, 30 K2 EDTA tubes, 31 K3 EDTA tubes, and 31 Gel Separation tubes.
  • Data Provenance: Implies prospective collection of samples drawn into different tubes.

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

Not applicable. This is an analytical performance study for an in-vitro diagnostic assay. Ground truth is established by reference methods, known concentrations, or comparison to a predicate device, not by expert medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication component in the analytical performance testing described for this device. Measurements are objective quantitative values.

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 an in-vitro diagnostic test, not an AI-assisted diagnostic imaging tool or a device requiring human readers/interpreters in its primary use.

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

This is fundamentally a "standalone" device in the sense that its performance is measured analytically on its own, producing a quantitative result. There is no "human-in-the-loop" performance as would be relevant for an AI-powered diagnostic imaging tool. The device provides a direct measurement.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance studies is based on:

• Reference Methods/Known Concentrations: For precision, linearity, and analytical sensitivity, samples with known or expected concentrations (e.g., controls, highly purified analytes, or diluted samples) are used.
• Comparison to a Legally Marketed Predicate Device: For method comparison, the results from the new device are compared to those obtained from the established predicate device, which serves as a de facto "truth" or reference standard for equivalence.
• CLSI Guidelines: The studies follow CLSI (Clinical and Laboratory Standards Institute) guidelines (e.g., EP5-A3, EP17-A2, EP6-A), which define how analytical performance characteristics should be determined using standard laboratory practices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set" in the context of model development. The laboratory studies described are for system validation, not algorithm training.

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

Not applicable. As there is no "training set" for an AI/ML model, there is no ground truth established for such a set.

Ask a specific question about this device

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.

Ask a specific question about this device

The Nano-Check ™AMI 3 IN 1 Test is a rapid immunoassay for the qualitative determination of Cardiac Troponin I (cTnl), Creatine Kinase MB (CK-MB), and Myoglobin in human serum and plasma specimens at cutoff concentrations of 0.5 ng/ml, 5.0 ng/ml, and 80 ng/ml, respectively, as an aid in the diagnosis of Acute Myocardial Infarction (AMI).

The Nano-Check™ AMI 3 IN 1 Test is a qualitative assay, which can not monitor the rise and fall of cTnl, CK-MB, and Myoglobin in single testing. Single testing is not recommended for AMI monitoring. Test results should be interpreted by the physician in conjunction with other laboratory test results and patient clinical findings.

The Nano-Check ™ AMI 3 IN 1 Test is a one-step lateral flow immunochromatography assay for the qualitative determination of three cardiac markers simultaneously in serum and heparin plasma.

The test is a single-use, visually read, cassette device in a plastic housing. Membrane strip inside the plastic housing contains immobilized molecules at three test lines and one control line; CK-MB antibody, Myoglobin antibody, streptavidine and goat anti-mouse antibody. Dye pad at the end of the membrane strip contains biotinylated cTnl antibody and gold colloidal particles coupled with CK-MM, cTnl and Myoqlobin antibodies. Cutoff level of each marker is 0.5 ng/ml, 5 ng/ml and 80 ng/ml for cTnl. CK-MB and Myoglobin respectively.

Device is sealed in pouch with desiccant and provided with instructions for use and disposable sample dropper.

The provided document is a 510(k) summary for the Nano-Check™ AMI 3 IN 1 Test, which is a qualitative immunochromatography assay for cardiac markers. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report for AI/CADe devices.

Therefore, much of the requested information (like specific acceptance criteria values, sample sizes for test sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance with metrics like sensitivity/specificity/AUC, detailed ground truth establishment for training, and training set size) is not present in this document. This submission primarily relies on "analytical performance" and "method comparison" studies, not complex clinical effectiveness studies with human readers or large-scale AI validation.

Here's a summary of what can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as clear numerical thresholds for performance metrics. Instead, it refers to "overall performance and characteristics" and "analytical performance" being addressed to support substantial equivalence. The "performance" is demonstrated by addressing analytical characteristics and comparing them to a predicate device.

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

• Sample Size: Not specified in the provided summary. The document mentions "Method Comparison with Predicate Device" and "Analytical Performance" studies, but does not provide the number of samples used in these non-clinical tests.
• Data Provenance: Not specified. Given it's a 510(k) for an IVD, these stability and analytical studies are typically conducted at the manufacturer's site or contracted labs. Country of origin for data is not mentioned.
• Retrospective/Prospective: Not specified, but analytical and method comparison studies are often conducted using banked samples (retrospective) or spiked samples.

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

• Not Applicable. This device is a diagnostic assay (an IVD) run on a sample (serum/plasma), not an imaging AI device that relies on expert interpretation for ground truth. The "ground truth" for such assays is established through reference methods (e.g., highly accurate laboratory analyzers) and spiked samples with known concentrations. The summary does not involve human readers interpreting images.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. This is an in-vitro diagnostic device, not an AI/CADe system requiring human adjudication of interpretations.

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

• No. An MRMC study is not mentioned or implied because this is an in-vitro diagnostic test. These studies are relevant for imaging devices where human readers interpret medical images with and without AI assistance.

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

• Yes, implicitly. The entire device is the "algorithm only" in the context of its function as an IVD. It's a qualitative test that produces a visual result (red bands) indicating the presence or absence of cardiac markers above a cutoff. Its performance is evaluated through analytical studies (precision, accuracy relative to reference, detection limit, specificity, etc.) which collectively represent its standalone performance characteristics. However, detailed results of these studies (e.g., sensitivity, specificity derived from analytical studies) are not provided in this summary.

7. The Type of Ground Truth Used:

• For analytical performance studies (Detection Limit, Analytical Specificity, Assay Cut-off), the ground truth would typically be established using:
  • Known concentrations: Samples (serum/plasma) spiked with known, precise concentrations of cTnl, CK-MB, and Myoglobin.
  • Reference methods: Comparison against established, high-accuracy laboratory reference assays for these cardiac markers.
  • Clinical correlation: While not a direct "ground truth" for the device's output, the overall utility is "as an aid in the diagnosis of Acute Myocardial Infarction (AMI)," implying that the presence of these markers above the cutoff correlates with AMI, which would be pathology-confirmed or clinically adjudicated. However, the study supporting this 510(k) focused on analytical performance and comparison to a predicate, not clinical outcomes directly.

8. The Sample Size for the Training Set:

• Not Applicable/Not Specified. This device is a lateral-flow immunochromatographic assay, not a machine learning or AI model that requires a distinct "training set" in the conventional sense. Its "training" is inherent in the chemical and manufacturing process design to ensure appropriate binding and visual signaling at the defined cutoffs.

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

• Not Applicable/No training set in the conventional sense. As explained in point 8, this device doesn't have a "training set" like an AI algorithm. The assay's "truth" (i.e., its ability to correctly identify positive/negative samples) is built into its biochemical design and validated through analytical studies, as outlined in section 7a.

Ask a specific question about this device

The i-STAT CK-MB test is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis of myocardial infarction (MI).

The cartridge is to be used with the i-STAT 1 Analyzer bearing the (Immuno) symbol, but not with the i-STAT Portable Clinical Analyzer or the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the CK-MB test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements on cardiac troponin I are used as an aid in the diagnosis and treatment of patients with acute myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.

The i-STAT CK-MB test is contained in a single-use test cartridge. In use, the user scans a bar code and then places approximately 16 uL of whole blood or plasma in the cartridge. After the cartridge is closed, it is inserted into the thermally controlled i-STAT 1 Analyzer, and all analytical steps are performed automatically. Patient and use information may be entered into the analyzer via a keypad during the automated analysis cycle.

As the analyzer performs several quality checks and controls the temperature of the sensors via resistive heating to the underside of the sensor chips, the substratelwash fluid is released into a conduit within the cartridge and a metered volume of the sample over the sensor chips. The enzyme-linked antibody conjugate dissolves into the sample and the sample incubates for a controlled time. The sample is then pushed into a waste chamber and the substrate/wash solution is brought over the sensors. The alkaline phosphatase captured on the CK-MB sensor cleaves the substrate present in the substrate/wash fluid, giving rise to an amperometric signal which is measured.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the i-STAT CK-MB Test.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are not explicitly stated as numerical targets in the document. Instead, the general criteria are that the device should be "substantially equivalent" to the predicate device in terms of performance and safety. The reported device performance is compared to the predicate and to laboratory standards.

• Slope: 1.01
• Intercept: -0.19
• Correlation: 0.994
  **Samples where [CK-MB]

Ask a specific question about this device

For in vitro diagnostic use in the quantitative determination of creatine kinase-MB in recommended when Acute Myocardial Infarction is suspected.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a Creatine Kinase-MB Reagent Set. This document is a regulatory clearance for an in vitro diagnostic device and does not contain the detailed study information typically found in clinical trials for AI/ML-based medical devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the input document. The document primarily focuses on regulatory approval, substantial equivalence to a predicate device, and general regulatory requirements for marketing the device.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Details about experts for ground truth establishment or adjudication methods.
• Information on MRMC comparative effectiveness studies or standalone performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how their ground truth was established.

This is a clearance letter for a chemical reagent set, not an AI/ML-driven device, so the type of performance data requested is not applicable to this document.

Ask a specific question about this device

The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA).

The VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA). It is substantially equivalent to the Ciba-Corning Magic Lite CK-MB assay.

Below is a summary of the acceptance criteria and study information for the VIDAS CKMB assay, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: The document does not explicitly state the total number of samples used for all the performance studies.
  • For the correlation study, the sample size is not specified beyond "a comparison of the VIDAS CKMB assay with the Ciba-Corning Magic Lite CK-MB assay yields a line...".
  • For the inter-assay, inter-instrument reproducibility, 5 different serum samples were used.
  • The sample sizes for sensitivity, cross-reactivity, interfering substances, and intra-assay/inter-assay precision are not detailed.
• Data Provenance: Not specified. There is no mention of the country of origin of the data, nor whether the data was retrospective or prospective.

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

• Not Applicable: This assay measures the concentration of creatine kinase MB isoenzyme. The "ground truth" for quantitative assays like this is typically established by reference methods or established analytical techniques, often using certified calibrators or highly characterized samples, rather than human expert consensus, pathology, or outcomes data. The document refers to a "calibrator in the kit" that ensures the master curve's validity.

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers are interpreting images or making subjective diagnoses. For a quantitative immunoassay like the VIDAS CKMB, the "ground truth" is determined analytically, and human adjudication is not relevant.

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 is a diagnostic assay for measuring a biomarker, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

• Yes (Implicit): The studies described (correlations, sensitivity, cross-reactivity, interference, precision) evaluate the performance of the VIDAS CKMB assay itself, independent of human interpretive input beyond standard laboratory practices for running the assay. The device provides a quantitative result.

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

• Analytical Reference / Predicate Device Comparison:
  • For correlation, the predicate device (Ciba-Corning Magic Lite CK-MB assay) served as a reference.
  • For sensitivity, cross-reactivity, interference, and precision, the ground truth is established by the known concentrations in control samples, precisely prepared interference matrices, and the inherent analytical capabilities of the assay system designed to measure a specific analyte. The calibrator also plays a role in establishing the measurement scale.

8. The sample size for the training set

• Not applicable / Not specified: This K962549 Summary describes the validation of a laboratory immunoassay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device typically involves the development and optimization of reagents, antibodies, and the instrument's detection algorithms, which isn't described as a discrete "training set" size in this document.

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

• Not applicable / Not specified: As mentioned above, this is an immunoassay validation, not an AI development report. The "ground truth" for the development of such an assay would likely involve extensive chemical and biological characterization of reagents and numerous experiments to optimize assay parameters. This information is not typically part of a 510(k) summary.

Ask a specific question about this device