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510(k) Data Aggregation
(88 days)
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis of heart or renal disease.
The Access Myoglobin assay is a sandwich immunoenzymatic assay. The Access Myoglobin assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access Myoglobin assay reagent pack, Access Myoglobin assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
The provided text describes the Beckman Coulter Access Myoglobin assay, which is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma. The K231832 submission seeks to demonstrate substantial equivalence to the predicate device (Access Myoglobin assay, K021229) when run on the Dxl 9000 Access Immunoassay Analyzer.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section with pass/fail thresholds for all performance metrics. However, it presents the results of various performance studies against industry guidelines (CLSI standards), which implicitly serve as the acceptance criteria for demonstrating appropriate performance.
| Performance Characteristic | Acceptance Criteria (Implicit from CLSI guidelines and typical assay requirements) | Reported Device Performance (Access Myoglobin on Dxl 9000) |
|---|---|---|
| Method Comparison (vs. Predicate) | Slope near 1.0, Intercept near 0, High correlation (R) | Slope: 0.99, Intercept: 0.47, R: 1.00 |
| Imprecision | ≤ 1.10 ng/mL SD at concentrations ≤ 11.0 ng/mL; ≤ 10.0% CV at concentrations > 11.0 ng/mL | Repeatability (Within-Run): 2.0-2.3% CV, 0.18 SD (low) |
| Between-Run: 2.2-4.0% CV, 0.18-85.9 SD | ||
| Between-Day: 0.0-3.0% CV, 0.0-3.0 SD | ||
| Within-Laboratory: 3.7-5.4% CV, 0.31-101.9 SD | ||
| Linearity | Demonstrate linearity across the measuring interval (e.g., polynomial fit not significantly better than linear) | Demonstrated linearity across the measuring interval |
| Limit of Blank (LoB) | Establish a LoB that is analytically sound | 3.0 ng/mL (μg/L) |
| Limit of Detection (LoD) | Establish a LoD that is analytically sound | 3.0 ng/mL (μg/L) |
| Limit of Quantitation (LoQ) | Establish a LoQ with acceptable imprecision (e.g., ≤ 20% within-lab CV) | 3.0 ng/mL (μg/L) at ≤ 20% within-lab CV |
2. Sample Sizes Used for the Test Set and Data Provenance
- Method Comparison: N = 155 (This refers to 155 patient samples). The data provenance (country of origin, retrospective/prospective) is not specified in the provided text.
- Imprecision: N = 80 per sample assessed (e.g., Sample 1, Sample 2, etc.), which involved multiple samples tested in duplicate in 2 runs per day for a minimum of 20 days.
- Linearity: Sample size not explicitly stated, but typically involves a series of diluted/spiked samples.
- LoB, LoD, LoQ: Not explicitly stated as a single "sample size" but involved multiple reagent lots and 3 instruments over a minimum of 3-5 days.
The data provenance for all studies (country of origin, retrospective or prospective) is not specified in the provided document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The Access Myoglobin assay is an in vitro diagnostic device for quantitative measurement of a biomarker. Its "ground truth" is established through analytical performance studies, not typically by expert review of individual cases as would be done for imaging or clinical decision support AI. Therefore, this section is not applicable in the traditional sense for this type of device. The "truth" is based on the accurate measurement of myoglobin concentration.
4. Adjudication Method for the Test Set
As this is an in vitro diagnostic quantitative assay, there is no adjudication method described or necessary in the context of expert consensus, as might be found for imaging AI. The performance is assessed against reference methods or calibrated controls.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No MRMC comparative effectiveness study was done. This type of study is relevant for imaging or clinical decision support AI where human readers interpret results, and the AI might augment their performance. For a quantitative immunoassay, the "reader" is effectively the instrument, and the performance is evaluated on its analytical accuracy and precision.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies presented (Method Comparison, Imprecision, Linearity, LoB/LoD/LoQ) demonstrate the standalone performance of the Access Myoglobin assay on the Dxl 9000 Access Immunoassay Analyzer. These are analytical performance studies of the device itself, without human interpretation as a primary variable.
7. The Type of Ground Truth Used
The ground truth for these analytical performance studies is based on:
- Reference measurements: For method comparison, the predicate device (Access 2 Immunoassay System) served as the reference standard.
- Established concentrations/materials: For imprecision, linearity, LoB/LoD/LoQ, the ground truth is based on known concentrations of myoglobin in controls, calibrators, and spiked samples, prepared according to industry standards.
- Analytical principles: The assay measures myoglobin concentration, and the "ground truth" is the actual quantity of myoglobin present in a sample, determined through scientifically validated methods.
8. The Sample Size for the Training Set
This information is not provided in the document. For an immunoassay like this, there isn't a "training set" in the machine learning sense. The device's operational parameters and assay design are developed through extensive research and development, but this is distinct from an AI training dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no explicit "training set" in the AI sense for this immunoassay submission, this question is not directly applicable. The "ground truth" during the development and optimization of such an assay would involve internal analytical studies using characterized materials and reference methods to ensure the assay accurately measures myoglobin concentrations.
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(179 days)
The Diazyme Myoglobin Assay is for the quantitative determination of myoglobin in human serum and plasma. Measurement of myoglobin is used as an aid in the diagnosis of acute myocardial infarction. For in vitro diagnostic use only.
The Diazyme Myoglobin Calibrator Set is intended for use in the calibration of the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Control Set is intended for use as quality controls for the Diazyme Myoglobin Assay. For in vitro diagnostic use only.
The Diazyme Myoglobin Assay is based on a latex enhanced immunoturbidimetric assay. When an antigen-antibody reaction occurs between myoglobin in a sample and anti-myoglobin antibodies which have been sensitized to latex particles, agglutination occurs. This agglutination is detected as an absorbance change (570 nm), with the magnitude of the change being proportional to the quantity of myoglobin in the sample. The actual concentration is then determined by the interpolation from a calibration curve prepared from calibrators of known concentration.
The Diazyme Myoglobin Assay's acceptance criteria and performance are detailed across sections of the provided document. The study primarily relies on method comparison and precision evaluations to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison | High correlation (R² close to 1) and a slope close to 1 with an intercept close to 0 when compared to the predicate device. | R² = 0.9855, Slope = 0.9526, Y-intercept = -4.2228. This is reported as correlating "well" with the predicate method. |
| Precision - Within-Run CV% | Not explicitly stated but generally expected to be low (e.g., typically < 10% for diagnostic assays, especially at higher concentrations) | Control Level 1: 3.71%Control Level 2: 3.87%Control Level 3: 3.54%Serum Level 1: 4.69%Serum Level 2: 2.37%Serum Level 3: 4.80% |
| Precision - Total CV% | Not explicitly stated but expected to be low and within acceptable laboratory limits. A total precision of <10% to 15% is common, with lower percentages desired. | Control Level 1: 5.10%Control Level 2: 4.30%Control Level 3: 4.40%Serum Level 1: 5.20%Serum Level 2: 3.58%Serum Level 3: 5.30% |
| Linearity | The assay should demonstrate linearity across its reportable range. | Linear from 13.2 to 615.9 ng/mL. |
| Interference | Less than 10% deviation from the true value when tested with common interferents at specified concentrations. | Less than 10% deviation for all listed interferents at specified concentrations, except for Intralipid above 125 mg/dL. |
The document states, "These results meet the acceptance criteria" under the "Precision" section, implying that the reported precision values are within the pre-defined limits. The "Method Comparison" also states that the results "correlated well," implying acceptance.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Method Comparison: 66 human plasma samples.
- Precision:
- 3 levels of serum-based controls (N=80 for each level across 20 days, 2 runs/day, duplicates means 2022 = 80 measurements per control level).
- 3 serum samples (N=80 for each level, calculated the same way as controls).
- Linearity: Not specified as a number of individual samples, but prepared by mixing a low and high serum-based sample.
- Interference: Not specified.
- Data Provenance: The document does not explicitly state the country of origin for the human plasma and serum samples. It implies prospective testing, as samples were "tested with the Diazyme Myoglobin Assay," suggesting they were collected for the purpose of this study, but this is not explicitly confirmed for all studies. The samples are described as "human plasma samples" and "serum samples", indicating clinical origin rather than synthetic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of myoglobin. Ground truth for such assays is typically established through reference methods or highly characterized predicate devices, not expert consensus, pathology reviews, or outcome data in the same way an imaging or classification AI/CAD device would use. In this case, the ground truth for method comparison was the result obtained from the predicate device (Roche Tina-Quant Myoglobin Gen. 2 Test System).
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is an IVD assay, not a device requiring human expert adjudication for ground truth establishment. The performance is assessed against quantitative measurements from a predicate device or by statistical methods for precision and linearity.
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 in vitro diagnostic assay. MRMC studies are typically performed for imaging devices or CAD systems where human readers interpret results, and the impact of AI assistance on their performance is evaluated. This device provides a quantitative measurement, not an interpretation for a human reader to improve upon.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies reported (method comparison, precision, linearity, interference) represent standalone performance of the Diazyme Myoglobin Assay. The device directly produces a quantitative result of myoglobin concentration in human serum and plasma, with no explicit human-in-the-loop component for result generation. Its performance is evaluated intrinsically through laboratory experiments.
7. The Type of Ground Truth Used
- For Method Comparison: The performance of the predicate device (Roche Tina-Quant Myoglobin Gen. 2 Test System) served as the comparator or "ground truth" to which the Diazyme Myoglobin Assay was compared.
- For Precision, Linearity, and Interference: The "ground truth" is established by the known concentrations of myoglobin in the control materials and the carefully prepared linearity and interference samples. These are quantitative studies where the expected value is either known (for controls/calibrators) or mathematically derived (for linearity/interference).
8. The Sample Size for the Training Set
Not applicable. This device is a chemical assay, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. Its performance characteristics are inherent to the chemical reactions and detection system, and are established through analytical verification studies (like those described) rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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(37 days)
The ADVIA® Chemistry Myoglobin assay is for in vitro diagnostic use in the quantitative measurement of myoglobin in human serum or plasma on the ADVIA® Chemistry systems. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
The ADVIA Chemistry Myoglobin calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry system for Myoglobin assay.
The Myoglobin reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Myoglobin calibrator is a single analyte, human serum based product containing myoglobin derived from human heart source. The kit consists of 1 vial each of 4 calibrator levels which are lyophilized. The target concentrations of these calibrators are 50, 100, 200, and 720 ng/mL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several performance characteristics and the results obtained for the ADVIA® 1650 Chemistry Myoglobin Assay. Since this is a submission for substantial equivalence to a predicate device, the "acceptance criteria" are implicitly the performance levels of the predicate device or generally accepted clinical laboratory standards as guided by CLSI documents. The reported performance of the new device is compared to these.
| Performance Characteristic | Acceptance Criteria (Implicit/Guidance) | Reported Device Performance (ADVIA® 1650 Chemistry Myoglobin Assay) |
|---|---|---|
| Precision | As per CLSI EP05-A2 guidance | Within-run SD/CV: 0.70-4.22 SD, 0.5-0.8% CV (depending on sample/concentration)Total SD/CV: 1.41-10.23 SD, 1.8-6.2% CV (depending on sample/concentration) |
| Linearity/Assay Reportable Range | Linear range typically defined by predicate device or clinical needs | Linear/measuring range: 22 to 680 ng/mL |
| Limit of Blank (LoB) | As per CLSI EP17-A guidance | 12 ng/mL |
| Limit of Detection (LoD) | As per CLSI EP17-A guidance | 21 ng/mL |
| Limit of Quantitation (LoQ) | As per CLSI EP17-A guidance | 22 ng/mL |
| Method Comparison (Serum) | Good correlation with predicate device (ADVIA Centaur Myoglobin assay) | Correlation coefficient: 0.99Slope: 0.96 (95% CI: 0.95-0.98)Intercept: 12.5 ng/mL (95% CI: 8.3-16.7)Range tested: 19.9 - 684.0 ng/mL |
| Matrix Comparison (Plasma) | Good correlation with predicate device (ADVIA Centaur Myoglobin assay) | Correlation coefficient: 0.99Slope: 0.98 (95% CI: 0.96-1.00)Intercept: 14.1 ng/mL (95% CI: 8.1-20.1)Range tested: 18.9 - 624.1 ng/mL |
| Analytical Specificity (Interference) | < 10% variance from control in presence of interferents | No significant interference found at specified levels for unconjugated bilirubin, conjugated bilirubin, Intralipid, hemoglobin, total protein, and rheumatoid factor. Hemolysed samples should not be used. |
| Reference Range | Substantial equivalence to predicate device | < 110.0 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision:
- Serum Pool 1: 40 replicates (assayed over 5 days)
- Control 1, Control 2, Control 3: 80 replicates each (assayed over 20 days)
- Serum Pool 2, Serum Pool 3, Serum Pool 4: 80 replicates each (assayed over 20 days)
- Data Provenance: Not explicitly stated, but typically these types of studies are prospective lab studies conducted internally or by contract research organizations (CROs) for the manufacturer. The document doesn't mention country of origin or if samples were from specific patient populations, implying a general laboratory setting for assay validation.
- Linearity/Assay Reportable Range: Nine intermediate levels were created from low and high serum pools, plus two additional low levels. The total number of samples is not explicitly given but would be at least 11.
- Data Provenance: Not explicitly stated, but likely laboratory-prepared serum pools.
- Limit of Blank, Limit of Detection, Limit of Quantitation:
- LoB: 160 replicates of "zero" serum pool.
- LoD/LoQ: Several serum pools with myoglobin concentration up to 4 x LOD level. (Exact number not specified for these pools).
- Data Provenance: Not explicitly stated, likely laboratory-prepared or confirmed serum pools.
- Method Comparison (Serum): 71 serum samples. One sample was removed.
- Data Provenance: Not explicitly stated, but typically these are human patient samples. The country of origin is not specified, and it's not stated whether they were retrospective or prospectively collected for the study, but typically for method comparison, they would be prospectively selected from a relevant patient population.
- Matrix Comparison (Plasma): 64 plasma samples.
- Data Provenance: Similar to serum comparison, likely human patient samples. Country/retrospective/prospective not specified.
- Analytical Specificity (Interference): Test samples at specific myoglobin concentrations (50, 100, 400 ng/mL) were spiked with various interferents. The number of samples for each interferent type and concentration is not explicitly given but implies multiple measurements.
- Data Provenance: Not explicitly stated, likely laboratory-prepared spiked samples using various concentrations of human physiological interferents.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This device is a quantitative immunological test system for measuring myoglobin. The "ground truth" for the test set is established by the predicate device (ADVIA Centaur Myoglobin Assay), which is itself a legally marketed device. There is no explicit mention of human experts establishing a "ground truth" for individual patient samples in the way it might be done for an imaging device (e.g., radiologists). The performance is assessed against an established analytical reference method (the predicate).
4. Adjudication Method:
- Not applicable in the typical sense for a diagnostic imaging or clinical decision support device where human experts adjudicate. For analytical assays, the "adjudication" is inherent in the analytical method comparison and statistical analysis against the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation systems where human readers are making diagnoses. This device is an in vitro diagnostic (IVD) assay that provides a quantitative measurement, not an interpretation by a human reader.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the entire performance evaluation described (precision, linearity, LoB/LoD/LoQ, method comparison, interference) is a standalone (algorithm only) performance study. The ADVIA® 1650 Chemistry Myoglobin assay is an automated system that performs the measurement without direct human interaction in the analytical process after sample loading.
7. Type of Ground Truth Used:
- The primary "ground truth" used for evaluating the new device's performance is the results obtained from the predicate device (ADVIA Centaur Myoglobin Assay) and, for basic analytical characteristics like LoB/LoD/LoQ, established analytical methodologies and industry standards (CLSI guidelines). For interference, the ground truth is the absence of interfering substances, and deviations are measured against that.
8. Sample Size for the Training Set:
- This 510(k) summary is for an in vitro diagnostic (IVD) assay, not a machine learning or AI model in the typical sense that requires explicit "training data" in the submission. The methods (e.g., latex-particle-enhanced immunoturbidimetric) are based on established chemical and immunological principles. Therefore, there is no specific "training set" sample size mentioned or generally applicable in the context of such an IVD submission. The assay's parameters would have been optimized during its development phase, but these aren't typically documented as a "training set" in a 510(k).
9. How the Ground Truth for the Training Set Was Established:
- As there is no "training set" specified in the context of an AI/ML model for this IVD assay, this question is not applicable. The "ground truth" for developing and optimizing such an assay would be based on fundamental chemical/immunological principles and experiments to ensure accurate and precise measurement of myoglobin concentrations.
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(345 days)
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
Immunoassay for the in vitro quantitative determination of myoglobin in human serum and plasma. The Elecsys Myoglobin STAT assay is intended to aid in the rapid diagnosis of heart and renal disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys and cobas e immunoassay analyzers.
The Elecsys Myoglobin Immunoassay includes two applications of the same reagents with different incubation times of 18 minutes (Myoglobin assay) and 9 minutes (Myoglobin STAT assay). The assay is a two-step sandwich immunoassay, using two different monoclonal antibodies directed against human Myoglobin, with streptavidin microparticles, and electrochemiluminescence detection. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent barcode.
The acceptance criteria for the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay, along with the reported device performance, are detailed below. The study proves the device's substantial equivalence to a predicate device (Elecsys Myoglobin STAT assay K983176), rather than establishing new clinical effectiveness. Therefore, the information regarding multi-reader multi-case studies, expert adjudication, and detailed ground truth establishment for novel device performance is not fully applicable in the context of a 510(k) submission for substantial equivalence based on performance characteristics.
1. Table of Acceptance Criteria and the Reported Device Performance
| Feature | Acceptance Criteria (Predicate: Elecsys Myoglobin STAT assay K983176 Performance) | Reported Device Performance (Elecsys Myoglobin and Myoglobin STAT) |
|---|---|---|
| Measuring Range | 15-3000 ng/mL | 21-3000 ng/mL |
| Expected values (Men) | < 72 ng/ml | 28-72 ng/ml |
| Expected values (Women) | < 51 ng/ml | 25-58 ng/ml |
| Repeatability (Myoglobin assay) | ||
| @ 32.0 ng/mL | N/A (Predicate points are different) | 2.0% CV |
| @ 87.0 ng/mL | N/A (Predicate points are different) | 1.0% CV |
| @ 1020 ng/mL | N/A (Predicate points are different) | 1.8% CV |
| @ 1194 ng/mL | N/A (Predicate points are different) | 1.1% CV |
| @ 2474 ng/mL | N/A (Predicate points are different) | 1.8% CV |
| Repeatability (Myoglobin STAT assay) | ||
| @ 33.9 ng/mL | N/A (Predicate points are different) | 1.7% CV |
| @ 90.1 ng/mL | N/A (Predicate points are different) | 1.2% CV |
| @ 1016 ng/mL | N/A (Predicate points are different) | 1.8% CV |
| @ 1171 ng/mL | N/A (Predicate points are different) | 1.1% CV |
| @ 2468 ng/mL | N/A (Predicate points are different) | 2.2% CV |
| Repeatability (Predicate) | ||
| @ 43.0 ng/mL | 2.1% CV | N/A |
| @ 82.5 ng/mL | 1.3% CV | N/A |
| @ 237 ng/mL | 2.9% CV | N/A |
| @ 523 ng/mL | 2.9% CV | N/A |
| @ 672 ng/mL | 1.9% CV | N/A |
| @ 1147 ng/mL | 3.4% CV | N/A |
| @ 3056 ng/mL | 5.3% CV | N/A |
| Intermediate Precision (Total) (Myoglobin assay) | ||
| @ 32.0 ng/mL | N/A | 2.3% CV |
| @ 87.0 ng/mL | N/A | 1.5% CV |
| @ 1020 ng/mL | N/A | 2.5% CV |
| @ 1194 ng/mL | N/A | 1.8% CV |
| @ 2474 ng/mL | N/A | 2.2% CV |
| Intermediate Precision (Total) (Myoglobin STAT assay) | ||
| @ 33.9 ng/mL | N/A | 2.1% CV |
| @ 90.1 ng/mL | N/A | 1.3% CV |
| @ 1016 ng/mL | N/A | 2.2% CV |
| @ 1171 ng/mL | N/A | 1.3% CV |
| @ 2468 ng/mL | N/A | 2.6% CV |
| Intermediate Precision (Total) (Predicate) | ||
| @ 43.0 ng/mL | 2.6% CV | N/A |
| @ 82.5 ng/mL | 1.6% CV | N/A |
| @ 237 ng/mL | 3.6% CV | N/A |
| @ 523 ng/mL | 3.8% CV | N/A |
| @ 672 ng/mL | 2.3% CV | N/A |
| @ 1147 ng/mL | 4.0% CV | N/A |
| @ 3056 ng/mL | 6.7% CV | N/A |
| Method Comparison (Myoglobin assay vs. Predicate) | ||
| N | N/A | 129 |
| Range | N/A | 24 to 2945 |
| Passing/Bablok Slope | 1.01 (Predicate to its comparator) | 1.03 |
| Passing/Bablok Intercept | -0.135 (Predicate to its comparator) | 6.26 |
| Passing/Bablok r | 0.996 (Predicate to its comparator) | 0.987 |
| Linear Regression Slope | 0.997 (Predicate to its comparator) | 1.02 |
| Linear Regression Intercept | 1.284 (Predicate to its comparator) | 14.5 |
| Linear Regression r | 0.996 (Predicate to its comparator) | 0.999 |
| Deming Regression Slope | N/A | 1.00 |
| Deming Regression Intercept | N/A | 13.9 |
| Deming Regression r | N/A | 0.999 |
| Method Comparison (Myoglobin STAT assay vs. Predicate) | ||
| N | N/A | 139 |
| Range | N/A | 23 to 2523 |
| Passing/Bablok Slope | 1.01 (Predicate to its comparator) | 1.04 |
| Passing/Bablok Intercept | -0.135 (Predicate to its comparator) | -2.08 |
| Passing/Bablok r | 0.996 (Predicate to its comparator) | 0.955 |
| Linear Regression Slope | 0.997 (Predicate to its comparator) | 1.08 |
| Linear Regression Intercept | 1.284 (Predicate to its comparator) | -9.60 |
| Linear Regression r | 0.996 (Predicate to its comparator) | 0.988 |
| Deming Regression Slope | N/A | 1.09 |
| Deming Regression Intercept | N/A | -14.6 |
| Deming Regression r | N/A | 0.997 |
| Limit of Blank | Not Reported for predicate | 18 ng/mL |
| Limit of Detection | 21 ng/mL | 21 ng/mL |
| Limit of Quantitation | Not Reported for predicate | 25 ng/mL |
| Interferences (limitations) | Hemolytic: no effect up to 1.4 g/dL, Biotin: no effect up to 50 ng/mL, Lipemia: no effect up to 2200 mg/dL, Bilirubin: no effect up to 65 mg/dL, Rheumatoid factor: no effect up to 1500 IU/mL | Same as predicate |
Note: For the purpose of substantial equivalence, the reported device performance of the new assays is compared to the performance characteristics of the predicate device. Where specific acceptance criteria are not explicitly stated, the presented predicate device's performance often implicitly serves as the benchmark for demonstrating comparable characteristics.
2. Sample sizes used for the test set and the data provenance
- Method Comparison (Myoglobin assay): N = 129 samples were used for the test set.
- Method Comparison (Myoglobin STAT assay): N = 139 samples were used for the test set.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given it's a submission for an IVD device, the data for performance characteristics would typically be generated in controlled laboratory settings through prospective testing of manufactured lots and clinical sample comparisons.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. For an in vitro diagnostic (IVD) immunoassay, "ground truth" is typically established by reference methods, comparison with a predicate device, or established scientific principles and accepted standards for analyte detection and quantification, rather than expert human interpretation of imaging or clinical data. The study primarily compares the performance of the new device to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation (e.g., radiology images) where human readers may disagree. For an immunoassay, the "ground truth" for comparison is based on quantitative measurements from established methods or the predicate device, not human interpretation requiring 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 information is not applicable. The device is an immunoassay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool for human readers interpreting cases. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented are for the standalone performance of the Elecsys Myoglobin Immunoassay and Elecsys Myoglobin STAT Immunoassay systems. The reported results (e.g., precision, method comparison, limit of detection) reflect the performance of the assay and analyzer without human interpretation of the final quantitative result. Humans are involved in operating the analyzer and interpreting the numerical output, but the "performance" described is the analytical performance of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance characteristics presented is primarily based on:
- Comparison to a predicate device: The Elecsys Myoglobin STAT assay (K983176) serves as the primary comparator.
- Internal reference preparations/standards: The Myoglobin STAT assay traceability is against an in-house reference preparation.
- Calibrated methods: The predicate device was calibrated against Tina-quant Myoglobin, which in turn was calibrated against a nephelometric method.
- Defined analytical methods: E.g., for precision, the coefficient of variation (CV) is calculated based on repeated measurements of control samples or patient samples. For method comparison, it refers to the correlation and agreement with the predicate device's quantitative measurements.
8. The sample size for the training set
This document does not specify a "training set" in the context of machine learning or AI algorithms. For an immunoassay, the development involves optimization of reagents, antibodies, and protocols, often using a large number of samples for validation and calibration curve generation. The provided sample sizes relate to the evaluation of performance characteristics (e.g., N=129 and N=139 for method comparison studies) and are equivalent to "test sets" for analytical validation.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML sense, this question is not directly applicable. For the development and calibration of the immunoassay, the "ground truth" for defining the calibration curve and ensuring accurate quantification would be established through a rigorous process involving:
- Certified reference materials or secondary reference materials traceable to international standards (if available).
- Serial dilutions of known concentrations of myoglobin.
- Comparison with established methodologies (e.g., gravimetric, spectrophotometric, or other widely accepted quantitative techniques).
- Manufacturer's in-house reference preparations that are carefully characterized and validated.
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(364 days)
Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Measurement of myoglobin aids in the rapid diagnosis of heart and renal diseases.
The Access Myoglobin reagent and calibrators, the Access Immunoassay Analyzers comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
The provided 510(k) summary focuses on a single performance characteristic: imprecision. The submission is for a modified version of an already cleared device, and the only change noted is to the acceptable imprecision range in the Instructions For Use (IFU).
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from modified IFU) | Reported Device Performance (Myoglobin) |
|---|---|---|
| Total Imprecision (%CV) | ≤ 10% across the expected physiological range | 7.32% CV to 9.25% CV |
The reported device performance (7.32% CV to 9.25% CV) falls within the updated acceptance criteria (≤ 10% CV).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The summary mentions "concentrations from approximately 79 to 2405 ng/mL" for imprecision testing, but not the number of individual samples or replicates used.
- Data Provenance: Not explicitly stated. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The device is an immunoassay for quantitative determination of myoglobin, and the "ground truth" for evaluating imprecision is determined by statistical analysis of repeat measurements, not by expert interpretation of samples.
4. Adjudication Method for the Test Set
This information is not applicable as it relates to expert consensus for ground truth, which is not relevant for imprecision studies of an immunoassay.
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. This submission is for an immunoassay for myoglobin, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a laboratory immunoassay device, not an algorithm, and does not involve human-in-the-loop performance in the same way as an AI-driven image analysis tool. The performance described (imprecision) is inherently "standalone" in the sense that it measures the inherent variability of the assay itself.
7. The Type of Ground Truth Used
The ground truth for imprecision studies is the measured value itself and its statistical distribution. Repeated measurements of the same sample are used to assess the variability (imprecision) of the assay. There isn't an external "truth" in the way there would be for disease diagnosis (e.g., pathology).
8. The Sample Size for the Training Set
This information is not applicable. This device is a biochemical assay and does not involve machine learning models that require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this type of device.
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(36 days)
The Tina-Quant ® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
C.f.a.s. (Calibrator for automated systems) Myoglobin is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.
The Tina-Quant® Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. In this immunoturbidimetric method, latex-bound anti-myoglobin antibodies react with antigen in the sample to form an antigen/antibody complex which after agglutination can be determined turbidimetrically. The calibrator is C.f.a.s. Myoglobin and the recommended control material is the Myoglobin Control Set.
The Tina-Quant® Myoglobin Gen.2 Test System is an immunoturbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. The device aids in the rapid diagnosis of heart and renal disease.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic device, performance metrics like precision, measuring range, and lower detection limit are key acceptance criteria. The submission largely compares the performance of the new device to its predicate device rather than explicitly stating specific acceptance criteria thresholds. However, we can infer some criteria from the presented "Within-run precision" and "Between-run precision" values. The method comparison also serves as a crucial criteria, demonstrating agreement with the predicate.
| Characteristic | Acceptance Criteria (Inferred/Compared to Predicate) | Reported Device Performance (Tina-Quant® Myoglobin Gen.2 Test System) |
|---|---|---|
| Intended Use | Substantially equivalent to predicate: quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. | Quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers. |
| Indications for Use | Substantially equivalent to predicate: Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. | Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease. |
| Assay Principle | Substantially equivalent to predicate: Immunoturbidimetry. | Immunoturbidimetry. |
| Instrument Compatibility | Applied to Hitachi family and Integra family analyzers. (Improved compared to predicate which was Hitachi family only). | Hitachi family (including cobas c6000 series) and Integra family analyzers. |
| Reagent Stability (On-board) | Improved/equivalent to predicate's 28 days at 2-8 °C. | 12 weeks opened and refrigerated. (Significantly improved) |
| Reagent Composition | Minor variations in stabilizers in R1, different procedure for coating latex with antibody in R2, but using the same antibody as predicate. Overall, composition should not negatively impact performance. | R1: same except for minor variations in stabilizers; R2: Same antibody but different procedure for coating latex with antibody. |
| Measuring Range | Equivalent or improved compared to predicate (3-560 ug/L, with extended range 3-4500 ng/mL). | Hitachi 902: 30-580 ug/L. Other Hitachi: 20-580 ug/L, 20-5800 ug/L with extended measuring range. (Wider extended range on "Other Hitachi" vs predicate, but higher lower end on Hitachi 902) |
| Lower Detection Limit | Equivalent or lower than predicate (3 ug/L). | Hitachi 902: < 20 ug/L. Other Hitachi: < 15 ug/L. (Higher than predicate) |
| Within-run Precision (%CV) | Should be comparable to or better than predicate (2.6% at 32.3 ug/L, 0.9% at 71.3 ug/L, 0.3% at 471.5 ug/L). Lower %CV indicates better precision. | 1.1% at 36.3 ug/L; 0.7% at 60.9 ug/L; 0.3% at 252 ug/L; 0.7% at 129 ug/L. (Generally improved performance across comparable concentration ranges, especially at lower concentrations). |
| Between-run Precision (%CV) | Should be comparable to or better than predicate (3.3% at 71.4 ug/L, 1.7% at 459.1 ug/L). Lower %CV indicates better precision. | 2.0% at 63.1 ug/L; 1.4% at 240 ug/L; 1.8% at 62.4 ug/L; 1.8% at 265 ug/L. (Generally improved performance across comparable concentration ranges). |
| Interferences | Should demonstrate non-interference or equivalent/improved interference profile compared to predicate. | No significant interference up to: I index of 60 (Bilirubin up to 60 mg/dL); H index of 500 (Hemoglobin up to 500 mg/dL); L index of 500 (Intralipid); Rheumatoid factors up to 100 IU/mL. No interference from 18 commonly used pharmaceuticals. Caveats for gammopathy and high-dose hook effect (>10000 ug/L). (Comparable/expanded data on specific interferents, and new pharmaceutical interference data). |
| Method Comparison (Regression) | Demonstrate strong correlation (high 'r' value) and agreement (slope near 1, intercept near 0) with the predicate device using Passing-Bablok regression. | y = Tina-Quant® Myoglobin Gen.2, x = Tina-Quant Myoglobin. Passing-Bablok results: y = 1.016x + 4.3; T = 0.961; r = 0.992. (Strong correlation and good agreement with a slight positive bias and slope slightly above 1). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the "test set" in the traditional sense of a clinical validation study with patient samples. The performance data presented (precision, measuring range, detection limit, interference, method comparison) come from internal validation studies.
- Precision:
- Within-run precision: Data points provided for 4 different myoglobin concentrations. The document does not specify the number of replicates or runs for each concentration.
- Between-run precision: Data points provided for 4 different myoglobin concentrations. The document does not specify the number of replicates, runs, or days.
- Method Comparison: The Passing-Bablok regression shows
r = 0.992, indicating a strong correlation. However, the exact number of samples (n) used for this comparison is not provided. - Interference: "No interference from 18 commonly used pharmaceuticals." The number of samples/tests for each interfering substance is not specified.
Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given it's an in-vitro diagnostic device submission, the data is typically generated in a controlled laboratory setting (prospective) by the manufacturer, Roche Diagnostics, which is based in Indianapolis, IN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to immunodiagnostic assays like the Tina-Quant® Myoglobin Gen.2 test system. The "ground truth" for quantitative assays is established by reference methods or by the predicate device (as seen in the method comparison). There are no human "experts" establishing a subjective ground truth for myoglobin concentration. The "ground truth" concentrations are determined by the predicate device or a reference method.
4. Adjudication Method for the Test Set
Not applicable for a quantitative in-vitro diagnostic device measuring a biomarker. The measurements are objective numerical values, not subjective interpretations requiring 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
Not applicable. This device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human "readers" or interpretations in the way an MRMC study evaluates.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone algorithm/test system. It provides a quantitative result without direct human interpretation of complex images or signals. The "algorithm" is the immunoturbidimetric assay itself, which is performed by automated clinical chemistry analyzers. The performance data presented (precision, measuring range, method comparison) are inherently "standalone" performance metrics of the diagnostic test system. The FDA 510(k) clearance process reviews the test system's performance against established criteria and comparison to a predicate device.
7. The Type of Ground Truth Used
For method comparison, the "ground truth" was the measurements obtained from the predicate device, Tina-Quant® Myoglobin Test System (K972513). The regression equation y = 1.016x + 4.3 where x is the predicate's result, indicates this comparison. For other performance characteristics like precision, the "ground truth" is typically the known concentration of controls or calibrators used in the experiments.
8. The Sample Size for the Training Set
Not applicable. This is a traditional immunodiagnostic assay, not a machine learning or AI-based device that requires a "training set" in that context. The "training" of the assay refers to its development and optimization based on chemical and biological principles.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the machine learning sense. The optimization and validation of the assay's reagents and methods during development would rely on known myoglobin standards and reference methods to ensure accuracy and precision.
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(94 days)
ARCHITECT STAT MYOGLOBIN is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Myoglobin in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Myoglobin values are used to assist in the diagnosis of myocardial infarction (MI).
The ARCHITECT STAT MYOGLIBIN Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of myoglobin in human serum or plasma.
The ARCHITECT® STAT Myoglobin assay is a two-step immunoassay for the quantitative determination of myoglobin in human serum and plasma using CMA technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample and anti-myoglobin coated paramagnetic microparticles are combined and incubated. Myoglobin present in the sample binds to the anti-myoglobin coated microparticles. After washing, antimyoglobin acridinium labeled conjugate is added in the second step. Following another incubation and wash, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of myoglobin in the sample and the RLUs detected by the ARCHITECT® I* system optics.
Here's a summary of the acceptance criteria and study information for the ARCHITECT® STAT MYO immunoassay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text (K042924) is a 510(k) summary for a diagnostic device. In this type of submission, specific numerical acceptance criteria for performance metrics are often compared against the predicate device rather than against predefined, distinct "acceptance criteria" for the new device as would be seen in a clinical trial protocol. The primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device.
Therefore, the "acceptance criteria" are implied by the performance of the predicate device (Abbott AxSYM® MYO Assay, K983848), and the "reported device performance" demonstrates that the new device is substantially equivalent to that predicate. Explicit numerical acceptance criteria are not detailed in this summary, but rather the conclusion of substantial equivalence in key performance areas.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance |
|---|---|---|
| Precision | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Linearity | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Interferences | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Stability | Performance comparable to Abbott AxSYM® MYO Assay | Substantially equivalent to Abbott AxSYM® MYO Assay |
| Method Comparison (Clinical Equivalence) | Agreement with Abbott AxSYM® MYO Assay demonstrating substantial equivalence | Demonstrated substantial equivalence with AxSYM® MYO assay |
| Sample Stability | No systematic gain or loss of MYO detectability under evaluated storage conditions | No systematic gain or loss of MYO detectability under evaluated storage conditions for Lithium Heparin and Serum Separator tubes |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size for the clinical method comparison study. It only states that a "method comparison using the CLSI EP-9A (EP-9A) was also conducted with the ARCHITECT® STAT MYO and AxSYM® MYO assays."
- Sample Size: Not explicitly stated. CLSI EP-9A provides guidance on method comparison studies, which typically involve a reasonable number of patient samples to demonstrate correlation.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be a retrospective or prospective laboratory comparison of samples on two different devices. Given the context of a 510(k) in the US, it's likely the data was generated in a US-based laboratory, but this is not confirmed. It's an analytical and clinical comparison study, not a population-based study in terms of provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "experts" to establish ground truth in the traditional sense (e.g., radiologists interpreting images) is not applicable here. This is an immunoassay for a biomarker (myoglobin). The "ground truth" for the test set is established by the results from the predicate device (Abbott AxSYM® MYO Assay), which is already legally marketed and established. The study's purpose is to show agreement between the new device and the predicate device's measurements. There are no "experts" involved in determining the "truth" of the myoglobin levels other than the performance of the predicate method itself.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "ground truth" is primarily based on the predicate device's measurements. There is no independent panel or expert adjudication process described for the myoglobin values themselves. The adjudication, if any, would be in the statistical analysis and clinical interpretation of the comparison results by regulatory reviewers.
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 immunoassay for a biomarker. It is not an imaging AI device that involves human readers or their improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a standalone algorithm (an immunoassay performed by an automated instrument). Its performance is evaluated analytically and in comparison to a predicate device, without a human "in-the-loop" influencing the immediate result generation for a single test. The "human-in-the-loop" aspect comes in the clinician's interpretation of the measured myoglobin level in conjunction with other clinical data. The summary describes the standalone analytical performance of the ARCHITECT® STAT MYO immunoassay.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary "ground truth" for this comparative study is the measurements obtained from the legally marketed predicate device (Abbott AxSYM® MYO Assay). The new device's performance is compared against these established measurements to demonstrate substantial equivalence, rather than against an independent physiological "ground truth" like pathology or clinical outcomes. The clinical utility is framed in terms of its ability to measure myoglobin, which is then used by clinicians for diagnosis, but the study itself focuses on equivalence to an existing method.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a "training set." It is an immunoassay based on chemical and biological reactions. The development of such assays involves optimization and validation, but not in the sense of an "AI training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The development and calibration of the assay would involve various analytical methods to ensure accuracy and precision, but this is distinct from establishing "ground truth" for an AI model.
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(54 days)
Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Ouantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
Ouantex Myoglobin is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of myoglobin concentration in human serum or plasma (EDTA or Lithium Heparin) on Clinical Chemistry Systems as an aid in the diagnosis of myocardial infarction. For in vitro diagnostic use.
Quantex Ferritin / Myoglobin controls I/II are intended for use in monitoring the quality control of results obtained with the quantex Myoglobin reagents by turbidimetry. (NOTE: These controls were previously FDA cleared for use with quantex Ferritin, reference K040879.) For in vitro diagnostic use.
Quantex Myoglobin standard multipoint is intended for use in establishing the calibration curve for the quantex Myoglobin reagents by turbidimetry. For in vitro diagnostic use.
Here's a breakdown of the acceptance criteria and study information for the quantex Myoglobin device, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from Predicate) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation with predicate device (N Latex Myoglobin) | Slope: 0.99, Correlation Coefficient (r): 0.999 |
| Precision (Within-Run) | Low coefficient of variation (CV) | 1.1% CV (at 71.4 ng/ml myoglobin) 1.3% CV (at 229 ng/ml myoglobin) |
Note: The document focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "acceptance criteria" are not explicitly stated as numerical targets but are inferred from the performance of the predicate device and what is considered acceptable for such assays. The reported device performance metrics are presented to show the new device meets or exceeds these implied standards.
Study Details
-
Sample Size used for the test set and the data provenance:
- Sample Size: 67 samples
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) summary for a US FDA submission, it is likely that the data was generated within a controlled, possibly clinical, setting. It is not specified if the data was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. This device is an in vitro diagnostic assay for a quantitative measurement (myoglobin concentration), not an imaging or diagnostic AI requiring expert interpretation of ground truth. Its performance is compared to a reference method (the predicate device) or internal quality control standards.
-
Adjudication method for the test set:
- Not applicable/Not mentioned. As this is a quantitative measurement, the "ground truth" for the method comparison study is the result obtained from the predicate device, or the mean of multiple measurements for precision. Adjudication by multiple experts is not relevant here.
-
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, an MRMC comparative effectiveness study was not done. This device is a diagnostic assay for quantitative determination of myoglobin, not an AI-assisted diagnostic tool that aids human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented (method comparison and precision) represents the standalone performance of the quantex Myoglobin assay system. There is no human-in-the-loop component described for its basic operation as a laboratory test.
-
The type of ground truth used:
- For the method comparison study, the "ground truth" was established by the predicate device's measurements (N Latex Myoglobin). The new device's results were compared against these established values.
- For precision, the "ground truth" (or target values) were the mean concentration levels of the quality control materials (quantex Ferritin/Myoglobin controls I/II).
-
The sample size for the training set:
- Not applicable/Not mentioned. This device is a traditional immunoturbidimetric assay, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The development of such an assay involves analytical validation, not model training.
-
How the ground truth for the training set was established:
- Not applicable. As there is no "training set" in the context of an AI/ML device, this question is not relevant. The assay's analytical characteristics are developed and verified through standard laboratory procedures and calibration.
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(22 days)
For the in vitro quantitative measurement of myoglobin concentration in human serum or plasma (EDTA or heparin) to aid in the diagnosis of myocardial infarction.
For in vitro use in the calibration of the Vitros Immunodiagnostic System for the quantitative measurement of Myoglobin in human serum and plasma (EDTA or heparin).
Assayed for use in verifying the calibration range of the Vitros Immunodiagnostic System when used for the measurement of Myoglobin. For in vitro use.
The Vitros Immunodiagnostic System uses luminescence as the signal in the quantitative and semi-quantitative determination of selected analytes in human body fluids, commonly serum and plasma. Coated microwells are used as the solid phase separation system.
The system is comprised of three main elements:
-
- The Vitros Immunodiagnostic Products range of immunoassay products: Vitros Immunodiagnostic Products Myoglobin Reagent Pack, the Vitros Immunodiagnostic Products Myoglobin Calibrators and the Vitros Immunodiagnostic Products Myoglobin Range Verifiers, (which are combined by the Vitros Immunodiagnostic System to perform the Vitros Myoglobin assay), and Vitros Immunodiagnostic Products High Sample Diluent B.
-
- The Vitros Immunodiagnostic System -- instrumentation, which provides automated use of the immunoassay kits.
-
- Common reagents used by the Vitros System in each assay.
The Vitros System and common reagents are dedicated specifically for use only with the Vitros Immunodiagnostic Products range of immunoassay products.
The provided text describes the 510(k) summary for the Vitros Immunodiagnostic Products Myoglobin Reagent Pack, Calibrators, and Range Verifiers. This is an in vitro diagnostic (IVD) device, and the information typically required for an AI/ML SaMD acceptance criteria study (e.g., sample size for test set, number of experts, adjudication method) does not directly apply in the same way.
However, I can extract information related to the device's performance compared to a predicate device, which serves a similar purpose in demonstrating functional equivalence.
Here's an analysis based on the provided text, adapted for IVD devices:
Acceptance Criteria and Study for Vitros Immunodiagnostic Products Myoglobin Assay
The Vitros Immunodiagnostic Products Myoglobin Reagent Pack, Calibrators, and Range Verifiers were shown to be substantially equivalent to predicate devices through various analytical studies. The primary goal was to demonstrate comparable characteristics and performance to legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
For IVD devices, "acceptance criteria" for demonstrating substantial equivalence often involve comparisons of analytical performance characteristics (e.g., calibration range, precision, correlation) with a predicate device.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Vitros Myoglobin Assay) |
|---|---|---|
| Reagent Pack & Calibrators: | ||
| Calibration range | 0-1000 ng/mL (DADE Dimension RxL Myoglobin) | 0-2000 ng/mL (Vitros Myoglobin assay) |
| Basic principle | Solid phase immunoassay (DADE Dimension RxL Myoglobin) | Solid phase immunoassay (Vitros Myoglobin assay) |
| Tracer | Enzyme labeled (DADE Dimension RxL Myoglobin) | Enzyme labeled (Vitros Myoglobin assay) |
| Instrumentation | DADE Dimension Immunoassay System | Vitros Immunodiagnostic System |
| Antibody | Mouse monoclonal anti-myoglobin antibodies | Mouse monoclonal anti-myoglobin antibodies |
| Sample type | Serum and plasma (heparin) | Serum and plasma (EDTA or heparin) |
| Sample volume | 20μL | 10μL |
| Incubation time and temperature | 7 minutes at 37°C | 8 minutes at 37°C |
| Correlation to Predicate | Not explicitly stated as a strict acceptance criterion in the summary, but a correlation coefficient close to 1 and a slope close to 1 with minimal bias are generally expected for substantial equivalence. | Vitros Myoglobin = 0.990 x X + 0.81 (ng/mL), with a correlation coefficient of 0.997 (where X is DADE Dimension RxL Myoglobin Method). |
| Other performance characteristics | (Implied to be comparable) | Precision, analytical sensitivity, specificity, and expected values studies were performed (details in package insert). |
| Range Verifiers: | ||
| Intended Use | Verifying calibration range for cardiac Troponin I | Verifying calibration range for Myoglobin |
| Matrix | Freeze-dried human serum spiked with human analyte | Freeze-dried horse serum spiked with human analyte |
| Levels | Low and High | Low and High |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text states, "This relationship was determined from a panel of patient samples from a variety of clinical categories." A specific number for this panel is not provided within the summary.
- Data Provenance: The origin (e.g., country) of the patient samples or whether they were retrospective or prospective is not specified in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of IVD device submission. The "ground truth" for an assay is typically established through a reference method or target values assigned to calibrators, not through expert consensus on medical images or clinical judgment. The DADE Dimension RxL Myoglobin Method acts as the reference for comparison studies.
4. Adjudication Method for the Test Set
This is not applicable as the "test set" here refers to patient samples analyzed by two different diagnostic assays for comparison, not a set of cases requiring adjudication by human readers.
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 device is an immunoassay, not an AI/ML-driven diagnostic imaging or clinical decision support tool that involves human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is applicable in the sense that the device's performance as an assay system (analyzer + reagents) was evaluated independently and then compared to the predicate device. The correlation study directly assesses the "standalone" analytical performance of the new Vitros Myoglobin assay compared to the predicate. The reported correlation coefficient of 0.997 and the regression equation demonstrate this standalone analytical performance.
7. The Type of Ground Truth Used
The "ground truth" was established by the results from the predicate device (DADE Dimension RxL Myoglobin Method) when analyzing the same patient samples. This is a common method for demonstrating substantial equivalence for new IVD assays by comparing them to an already cleared and accepted method. Additional studies on precision, analytical sensitivity, specificity, and expected values provide further grounding for the assay's performance characteristics.
8. The Sample Size for the Training Set
This is not applicable. Immunoassays are not "trained" in the same way AI/ML algorithms are. There isn't a defined training set in the context of machine learning. The assay's analytical characteristics are developed and verified through chemical and biological experimentation, calibration, and validation with various samples (including spiked samples, proficiency samples, and patient samples).
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" in the AI/ML sense for this type of device. The accuracy of the assay is established through its analytical and clinical performance studies, often referencing established methodologies or certified reference materials.
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(71 days)
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
Measurement of myoglobin aids in the rapid diagnosis of heart and renal disease.
The Myoglobin reagents. Myoglobin calibrators, the Access Access Immunoassay Analyzer and the Access 2 Immunoassay Analyzer comprise the Access Immunoassay Systems for the quantitative determination of cardiac Myoglobin in human serum and plasma.
The document provided describes the Access Myoglobin assay. Here's a breakdown of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Consistent and reproducible results (low %CV) | - Within-run imprecision: 1.58%CV to 2.20%CV- Between-run imprecision: 2.34%CV to 4.24%CV- Total imprecision: 3.03%CV to 4.54%CV |
| Analytical Sensitivity | Ability to detect low levels of Myoglobin (distinguishable from zero) | The lowest detectable level of Myoglobin distinguishable from zero (with 95% confidence) is <1.0 ng/mL. |
| Dilution Recovery (Linearity) | Average recovery above a certain threshold (e.g., ~90-110%) | - Average recovery: 93%- Individual sample average recoveries: 86% to 100% |
| Method Comparison | Good agreement with a predicate device (high correlation, low bias) | - Comparison of 148 samples (0.00 to 3.227.80 ng/mL): - Equation: Y = 1.113X + 15.903 - Correlation Coefficient (R): 0.997 |
| Matched Sample Comparison | No clinically significant bias between different sample types | - Lithium heparin plasma vs. sodium heparin plasma or serum: No clinically significant bias noted.- EDTA plasma samples: A bias was noted (Y = 0.8925X + 5.0115, R = 0.9981). The document specifies "See Reference Interval section," indicating this bias was acknowledged and likely addressed with separate reference limits. |
| Analytical Specificity | No significant interference from common substances | - No significant interference from therapeutic drugs or biological substances.- None of the RF or HAMA samples tested above the Upper Reference Limit (URL).- Two heterophile samples tested above the URL and were not blocked by HBT, indicating a potential limitation for these specific samples. |
| Stability | Reagents and calibrators maintain performance over time | - Myoglobin reagents stable for 56 days after opening.- Calibrators stable for 60 days after opening.- Calibration curve stable for 56 days. |
| Reference Intervals | Established reference limits for different populations/sample types | - LHS (Lithium Heparin, Serum) URL (97.5th percentile): 66 ng/mL for Females, 106 ng/mL for Males.- EDTA URL (97.5th percentile): 58 ng/mL for Females, 91 ng/mL for Males. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Method Comparison: 148 samples were used.
- Dilution Recovery (Linearity): An unspecified number of lithium heparin plasma samples were used.
- Analytical Specificity: "None of the RF samples or the HAMA samples," and "Two heterophile samples."
- Reference Intervals: No specific sample size is given for the population used to establish the reference intervals, but separate limits were computed for LHS and EDTA assays for males and females.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- This document describes an in vitro diagnostic (IVD) device for quantitative determination of Myoglobin levels. For such devices, "ground truth" is typically established through a reference measurement procedure or comparison to a legally marketed predicate device, rather than through expert human interpretation of images or clinical findings.
- The predicate device used for comparison was the "Access® Myoglobin Beckman Coulter Inc." (510(k) Number: K000196). The performance of this predicate device serves as a benchmark for comparison.
- No human experts were explicitly "establishing ground truth" in the sense of consensus reads for the analytical performance studies.
4. Adjudication Method for the Test Set:
- Not applicable as this is an IVD device for quantitative measurement, not a system requiring human interpretation adjudication. Measurements are taken and compared to established analytical performance criteria and a predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging or interpretation systems where human readers are involved. This document describes an automated immunoassay system.
6. Standalone (Algorithm Only) Performance:
- Yes, the entire submission describes the standalone performance of the Access Myoglobin assay, which is an algorithm-driven automated immunoassay system. The reported performance metrics (precision, sensitivity, linearity, method comparison, etc.) are all for the algorithm (assay) itself, without human-in-the-loop performance being a variable.
7. Type of Ground Truth Used:
- For the analytical performance studies:
- Method Comparison: The "ground truth" for the new device was established by comparing its measurements against those obtained from the predicate device (Access® Myoglobin Beckman Coulter Inc., K000196). This is a common approach for demonstrating substantial equivalence for IVDs.
- Other analytical studies (e.g., precision, linearity, sensitivity): Ground truth is inherent in the experimental design, using known concentrations, samples with established values, or statistical methods to define performance characteristics. For instance, for sensitivity, the detection limit is determined against a zero calibrator.
8. Sample Size for the Training Set:
- The document does not specify a training set size. For an immunoassay, the "training" analogous to machine learning models often refers to the development and optimization of the assay reagents and protocols. The studies described are typically considered verification and validation studies (test sets) for the finalized assay.
9. How the Ground Truth for the Training Set Was Established:
- As above, explicit "training set ground truth establishment" in the context of machine learning is not directly applicable here. The development of an immunoassay involves extensive laboratory work to optimize reagent concentrations, reaction conditions, and calibration curves. This optimization process, drawing on many samples and experiments, is analogous to training. The performance of these optimized parameters is then validated through the analytical studies described.
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