(61 days)
The Quantech Myoglobin 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 non-cardiac damaging origin of the chest pain.
The Quantech Myoglobin Assay is based on the principle of two site, or sandwich immunoassay in combination with SPR surface mass measurement. Each test module contains a solid phase anti-myoglobin monoclonal antibody immobilized onto a gold surface. An anti-myoglobin enzyme conjugate solution and wash solution are used to enhance the specific detection of myoglobin.
The Quantech assay utilizes myoglobin-specific antibody to capture the myoglobin in the sample. This is followed by a quantitation of the surface mass increase using surface plasmon resonance (SPR), to measure the myoglobin in serum.
Here's a breakdown of the acceptance criteria and study information for the Quantech Myoglobin Assay based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | Dilution Linearity/Parallelism | Average % of expected: 107% (individuals 101-115%) |
| Recovery | Average recovery: 108% | |
| Analytical Sensitivity | 6 ng/mL | |
| Precision (Intra-assay) | Low: 61 (11.9% CV), Medium: 131 (9.7% CV), High: 378 (9.5% CV) ng/mL | |
| Precision (Inter-assay) | Low: 51 (7.1% CV), Medium: 110 (6.2% CV), High: 219 (10.3% CV) ng/mL | |
| Interfering Substances | Acceptable recovery in presence of bilirubin, triglycerides, hemoglobin (no interference noted) | |
| Hook Effect | No high dose hook effect observed up to 10,000 ng/mL | |
| Clinical Performance | Normal Range (Male) | 16-70 ng/mL (consistent with published literature 19-92 ng/mL) |
| Normal Range (Female) | 17-55 ng/mL (consistent with published literature 12-76 ng/mL) | |
| Overall Normal Range | 14-70 ng/mL | |
| Patient Sample Correlation (vs. predicate) | Correlation coefficient: 0.970 (slope = 1.16, y-intercept = 7.94 ng/mL) |
Note on Acceptance Criteria: The document describes the "Summary of Non-Clinical Performance Data" and "Summary of Clinical Performance Data" but does not explicitly state pre-defined acceptance criteria in numerical terms (e.g., "Recovery must be between 90-110%"). Instead, it presents the results of these performance tests, implying these results met the internal criteria for substantial equivalence to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
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Non-Clinical Performance:
- Dilution Linearity/Parallelism: "Serum samples were separately spiked with myoglobin and serially diluted..." - Specific sample size not provided.
- Recovery: Not explicitly stated.
- Analytical Sensitivity: "Multiple duplicates of zero samples (blank) were assayed..." - Specific number of duplicates not provided.
- Precision:
- Intra-assay: "replicate evaluation of three levels of sera in one day." - Specific number of replicates not provided.
- Inter-assay: "evaluating three pools (different from INTRAASSAY pools) in multiplicate on different days." - Specific number of replicates/days not provided.
- Interfering Substances: "spiking a serum pool of myoglobin with bilirubin, triglycerides and hemoglobin..." - Specific sample size not provided (likely a small number of spiked samples).
- Hook Effect: "Samples well beyond the standard curve range were assayed." - Specific sample size not provided.
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Clinical Performance:
- Normal Range: "Testing of apparently healthy individuals demonstrated a normal range..." - Specific number of individuals not provided.
- Patient Sample Correlation: "Results from human samples with values distributed throughout the quantitative range of the Quantech MYOGLOBIN Assay, were compared..." - Specific number of human samples not provided.
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Data Provenance: The document does not specify the country of origin for the data. The studies appear to be conducted by Quantech Ltd., located in St. Paul, MN, USA. There is no indication whether the data is retrospective or prospective. It is implied to be prospective testing for device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device is an in-vitro diagnostic (IVD) assay for measuring myoglobin in serum. The 'ground truth' for such a device is typically established through a reference method or known concentrations, rather than expert interpretation of images or clinical findings.
- For the patient sample correlation, the Quantech Myoglobin Assay results were compared to a "commercially available method (fluorogenic ELISA)," which serves as the comparative reference. The expert involvement here would be in running and interpreting the reference method, but no specific number of experts or their qualifications are mentioned.
4. Adjudication Method for the Test Set
- Not applicable in the conventional sense for an IVD assay. Adjudication methods (like 2+1 or 3+1) are typically used in image-based diagnostic studies where human experts interpret medical images.
- For this assay, "ground truth" for non-clinical performance (e.g., analytical sensitivity, precision) is determined by laboratory standards and established measurement methodologies. For clinical correlation, the predicate device/method serves as the reference, and agreement is measured statistically (correlation coefficient).
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 devices that involve significant human interpretation, such as radiology AI tools.
- This submission is for an IVD assay, where the output is a quantitative measurement, not an interpretation that varies significantly between human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Yes, the performance data presented (Dilution Linearity, Recovery, Analytical Sensitivity, Precision, Interfering Substances, Hook Effect, Normal Range, Patient Sample Correlation) reflects the standalone performance of the Quantech Myoglobin Assay itself. As an IVD kit, it provides a quantitative result without direct human intervention or interpretation of the assay's output to reach the result.
- The device design inherently focuses on standalone algorithm performance to generate a quantitative myoglobin value.
7. Type of Ground Truth Used
- For non-clinical performance (e.g., linearity, recovery, sensitivity, precision, interference, hook effect):
- Known concentrations/spiked samples: Myoglobin was added to samples at known levels to assess linearity, recovery, and other analytical characteristics.
- Reference standards/blanks: Used for analytical sensitivity determination.
- For clinical performance (normal range, patient correlation):
- Biologically established ranges: The normal range was determined by testing "apparently healthy individuals" and compared to "published literature."
- Comparative method/Predicate device results: For patient sample correlation, the "commercially available method (fluorogenic ELISA)" served as the reference standard to which the Quantech assay results were compared.
8. Sample Size for the Training Set
- The document does not provide any information regarding a "training set" or its size.
- This type of IVD device (sandwich immunoassay with SPR measurement) is typically developed using chemical and biological principles and optimization, rather than machine learning models that require distinct training sets. The development process likely involves extensive experimentation to optimize reagents, concentrations, and reaction conditions, but this is distinct from the concept of a "training set" in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
- As no training set is mentioned or applicable in the context of this traditional immunoassay device, this information is not provided and is likely not relevant to its development.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).