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510(k) Data Aggregation
(197 days)
MYT
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.
| Acceptance Criteria (Implied) | Reported Device Performance (i-STAT CK-MB Test) |
|---|---|
| Insensitivity to various hematocrit levels | Insensitive to hematocrit levels from 0 to 70 %PCV. |
| Not significantly influenced by other CK isoforms | Not significantly influenced by the presence of CK-BB at 100 ng/mL or CK-MM at 10,000 ng/mL. |
| Similar interference effects from common medications to predicate | Interference effects from common medications (especially those for cardiovascular conditions) were similar to the Triage Cardiac Panel CK-MB. |
| Acceptable Lower Limit of Detection (LLD) | LLD of 0.6 ng/mL (comparable to predicate's 1.0 ng/mL). |
| Adequate imprecision for various control levels | Level 1 control %CV: 11.9% at 5.9 ng/mL |
| Level 2 control %CV: 10.4% at 25.8 ng/mL | |
| Level 3 control %CV: 10.0% at 90.1 ng/mL | |
| Acceptable clinical correlation to predicate device (Abbott AxSYM) | All Samples (N=263): |
- Slope: 1.01
- Intercept: -0.19
- Correlation: 0.994
**Samples where [CK-MB]
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(104 days)
MYT
For in vitro diagnostic use with the BioCentrex Analyzer to quantitatively measure cardiac troponin-I, creatine kinase MB and myoglobin concentrations in anti-coagulated whole blood, serum or plasma.
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.
BioCentrex Cardiac Panel cartridges are used with the BioCentrex Analyzer to measure cardiac troponin I (CTnI), creatine kinase-MB, and myoglobin concentrations in whole blood, serum or plasma specimens.
The provided text is a 510(k) summary for the BioCentrex Cardiac Panel System. It details the device's technical specifications and performance characteristics, but does not explicitly lay out "acceptance criteria" in a structured table or specifically describe a "study that proves the device meets the acceptance criteria" in the way one might find in a clinical trial report.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through analytical studies. The performance metrics presented are common for in vitro diagnostic devices and are compared against the predicate devices for equivalency.
Here’s an interpretation of the available information structured to address your request, acknowledging the limitations of the provided document in explicitly defining "acceptance criteria" and a "single study report" in the typical sense.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" are not listed in the document as such, I will infer what would likely be considered acceptable performance based on common standards for diagnostic assays and the predicate devices' performance. The reported device performance will be taken directly from the "Summary of Analytical Studies."
| Performance Metric | Inferred Acceptance Criteria (e.g., comparable to predicate device, within acceptable precision ranges) | Reported Device Performance |
|---|---|---|
| Cardiac Troponin I | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 3.1 to 4.7 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 5.6 to 8.3 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 0.04 ng/mL |
| Dilution Recovery | Near 100% recovery | 99.7 % (average) |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.9953 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.992x + 0.316 (vs. predicate) |
| Functional Sensitivity (20% imprecision) | Defined limit for reliable detection | 0.15 ng cTnI/mL |
| CK-MB | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 6.3 to 7.8 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 7.7 to 8.9 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 0.41 ng/mL |
| Dilution Recovery | Near 100% recovery | 100.9 % (average) |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.995 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.995x + 0.313 (vs. predicate) |
| Myoglobin | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 6.1 to 7.5 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 7.0 to 7.8 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 2.8 ng/mL |
| Dilution Recovery | Near 100% recovery | No specific myoglobin recovery % given for dilution, but "average recoveries ... of 99.7 %, and 100.9 %" for cTnI and CK-MB are mentioned. It can be inferred that myoglobin also met similar linearity expectations. |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.985 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.965x + 6.5 (vs. predicate) |
| Analytical Specificity | No significant interference/cross-reactivity | No significant interference from therapeutic drugs, biological substances, heterophilic specimens, or cross-reactivity with other cardiac contractile proteins or CK isoenzymes. |
| Stability | Cartridge stable for stated period | 1 year at 2-8 °C (unopened); 24 hours at ambient (opened) |
2. Sample Size Used for the Test Set and Data Provenance
The document only provides sample sizes for the Method Comparison studies:
- Cardiac Troponin I: 101 specimens
- CK-MB: 73 specimens
- Myoglobin: 70 specimens
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "cardiac specimens," suggesting they were samples from patients, but further details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in vitro diagnostic assays, "ground truth" (or reference method results) is typically established by comparative analysis with a legally marketed predicate device (as done here) or a recognized gold standard laboratory method, rather than expert consensus on individual cases. The "experts" in this context would be the technicians or laboratory personnel performing the predicate method tests.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to determine the true clinical status of a patient, especially when imaging or clinical assessment is subjective. For analytical performance studies of an IVD device, the "ground truth" is typically the result from the established predicate/reference method, and no human adjudication process for interpreting these results is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The BioCentrex Cardiac Panel System is an in vitro diagnostic (IVD) device that measures biomarkers, not an AI-assisted diagnostic imaging or clinical decision support system that involves human readers interpreting cases. Therefore, an MRMC study or AI-related effect size data would not be relevant or expected for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not directly applicable in the context of an AI algorithm. However, the entirety of the analytical studies described (precision, sensitivity, linearity, method comparison, specificity, stability) represent the standalone performance of the BioCentrex Cardiac Panel System without human interpretation beyond standard laboratory procedures for running the assay and reporting results. The device is the "algorithm" and performs its measurements autonomously once the sample is loaded.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies was established by comparison to predicate devices (Access® AccuTnI™, Access® CK-MB, and Access® Myoglobin) which are legally marketed immunoassays. This is a common and accepted method for demonstrating substantial equivalence for new IVD devices. The results from the predicate devices served as the reference standard.
8. The Sample Size for the Training Set
This information is not provided and is likely not relevant in the context of this device. The BioCentrex Cardiac Panel System is an immunoassay, not a machine learning or AI-driven system that requires a "training set" in the typical sense. Its performance is based on biochemical reactions and optical detection, calibrated by known standards or calibrators rather than a large dataset of patient samples used for algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the machine learning sense is not applicable for this immunoassay device. The device would be "calibrated" using manufacturer-provided calibrators, and quality control materials would be run to ensure ongoing performance. These calibrators would have known concentrations of the target analytes.
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(322 days)
MYT
The Quantech CK-MB Assay is intended to be used as an aid in diagnosing myocardial infarction in patients exhibiting chest pain. It is intended to be used in conjunction with EKG, and physician examination, as well as possibly other biochemical blood tests to rule in or out origin of the chest pain.
The Quantech CK-MB Assay is intended to be used for the quantitative determination of the cardiac isoenzyme CK-MB, in order to assist in the diagnosis of acute myocardial infarction.
The Quantech CK-MB assay is based on the principle of two site, or sandwich immunoassav in combination with SPR surface mass measurement. Each test module contains a solid phase anti-CK-MB monoclonal antibody immobilized onto a gold surface. An anti-CK-MB polyclonal antibody, used to enhance the specific detection of the isoenzyme is introduced sequentially.
The Quantech assay utilizes CK-MB-specific antibody to capture the CK-MB in the sample. This is followed by a quantitation of the surface mass increase using surface plasmon resonance (SPR), to measure the CK-MB in plasma.
The provided text describes the Quantech CK-MB Assay, an in vitro immunological assay for the quantitative measurement of human CK-MB, intended to aid in diagnosing myocardial infarction. The submission seeks substantial equivalence to the AxSYM® CK-MB assay.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values in a table. Instead, it presents performance data and concludes that the device's performance is "acceptable" or "demonstrates essential equivalence" to the predicate device. The "accepted value for cardiac damage" is mentioned as "greater than 7.0 ng/mL CK-MB", which can be considered a clinical threshold, but not a specific acceptance criterion for the device's technical performance.
Here's a summary of the reported device performance:
| Performance Metric | Reported Device Performance (Quantech CK-MB Assay) |
|---|---|
| Dilution Linearity/Parallelism | Average percent of expected: 118% (deemed acceptable) |
| Recovery | Average recovery: 103% (corrected for endogenous analyte; deemed acceptable) |
| Analytical Sensitivity | 0.3 ng/mL |
| Precision (INTERASSAY) | Low pool (37.5 ng/mL): 9.4% CV; Medium pool (83.1 ng/mL): 4.8% CV; High pool (149 ng/mL): 7.0% CV |
| TOTAL IMPRECISION | Low pool (37.5 ng/mL): 13.3% CV; Medium pool (83.1 ng/mL): 9.1% CV; High pool (149 ng/mL): 10.1% CV |
| Interfering Substances | Percent recovery of CK-MB determined to be acceptable in all three solutions (hemoglobin, bilirubin, triglycerides); no interference noted. |
| Hook Effect | No high dose hook effect observed up to at least 5,000 ng/mL. |
| Normal Range (vs. predicate) | Performs similarly at and below 7.0 ng/mL CK-MB. 95% limit of normals: 4.2 ng/mL (vs. predicate's 3.8 - 6.5 ng/mL). No false positives. |
| Patient Sample Correlation | Correlation coefficient: 0.95 (slope = 0.81, y-intercept = 0.37 ng/mL) with a commercially available method (fluorogenic ELISA). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the exact sample size for the clinical test sets.
- For the "Normal Range" study, it mentions "Testing of apparently healthy individuals" and "samples containing high levels of either RF or HAMA". The specific number of individuals or samples is not provided.
- For "Patient Sample Correlation", it mentions "Results from human samples with values distributed throughout the quantitative range". The specific number of human samples is not provided.
- Data Provenance: The document does not specify the country of origin of the data. It implies the data is retrospective as it compares the new device with an existing "predicate device" (AxSYM® CK-MB assay marketed by Abbott Laboratories since 1993) and a "commercially available method (fluorogenic ELISA)".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic (IVD) assay for measuring a biochemical marker (CK-MB levels). The "ground truth" for the test set is the actual CK-MB concentration in the samples, determined by reference methods or the predicate device, not by expert interpretation of images or clinical data.
4. Adjudication Method for the Test Set
Not Applicable. As an IVD assay, the ground truth is established by the concentration of the analyte, not by expert consensus requiring adjudication. Comparisons are made against the predicate device or a reference method.
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 an IVD assay, not an AI-assisted diagnostic imaging or clinical decision support tool that involves human readers. Therefore, an MRMC study and effect size on human readers are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are standalone performance evaluations of the Quantech CK-MB Assay itself. The performance data (linearity, recovery, sensitivity, precision, interference, hook effect, normal range comparison, and patient sample correlation) all represent the direct output of the algorithm/device without explicit human intervention in the result generation or interpretation phase beyond standard laboratory procedures for operating the instrument and collecting samples.
7. The Type of Ground Truth Used
The ground truth for the performance studies was:
- Reference measurements/Predicate Device: For "Normal Range" and "Patient Sample Correlation," the Quantech CK-MB Assay's results were compared against the AxSYM® CK-MB assay (predicate device) and a "commercially available method (fluorogenic ELISA)". The predicate device's established values and the results from the alternative commercial method served as the comparative "truth".
- Known Spiked Concentrations: For "Dilution Linearity/Parallelism" and "Recovery", samples were "spiked with CK-MB" at known concentrations.
- Stripped Plasma: For "Analytical Sensitivity", "zero samples (stripped plasma)" were used to determine the minimum detectable quantity, implying a known absence of the analyte.
- Physiological Interference: For "Interfering Substances", known levels of interferents (hemoglobin, bilirubin, triglycerides) were added to CK-MB samples.
8. The Sample Size for the Training Set
The document does not provide information on a specific "training set" or its sample size. This type of regulatory submission for an IVD assay typically focuses on validation and verification studies rather than machine learning model training. The assay relies on established immunoassay principles, not a learnable algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a distinct "training set" for a machine learning algorithm is not described or implied for this device. The development of the assay itself would have involved internal optimization and calibration using reference materials and characterized samples, but this is distinct from a machine learning training set.
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