(94 days)
The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting.
The INSTANT-VIEW Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.
A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with anti- Troponin I antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti- Troponin I antibodies, and the C line is coated with goat anti-mouse IgG antibodies.
The proposed device has two formats: Serum Test and Whole Blood/Serum Test. The Serum Test has two sub-formats: Cassette and Dip Strip. The Whole Blood/Serum Test only has the cassette format. A cassette is a device that assembles a dip-strip in a plastic housing. The studies demonstrate all the formats are equivalent.
Acceptance Criteria and Study for INSTANT-VIEW Troponin I Test
This response analyzes the provided 510(k) summary for the INSTANT-VIEW Troponin I Test to extract information about its acceptance criteria and the study conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | High (e.g., >95%) | 99.3% (149/150) |
| Specificity | High (e.g., >95%) | 96.0% (144/150) |
| Overall Accuracy | High (e.g., >95%) | 97.7% (293/300) |
| Reproducibility | High agreement (e.g., >95%) | Over 98.8% agreement |
| Cross-Reactivity | No cross-reaction | No cross-reaction observed with closely related substances |
| Interference | No interference | No interference observed with endogenous substances or commonly used drugs |
Note: The acceptance criteria are "implied" as they are not explicitly stated with numerical thresholds in the provided document. However, the study results demonstrate high performance that would typically be required for such a device.
2. Sample Size and Data Provenance for Test Set
- Sample Size: 300 clinically confirmed serum specimens (150 positive and 150 negative).
- Data Provenance: Retrospective, as the specimens were "clinically confirmed." The country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth of the 300 clinically confirmed serum specimens. The phrase "clinically confirmed" implies that the diagnosis (positive or negative for myocardial infarction) was established through standard clinical practice, likely involving medical professionals (e.g., cardiologists, emergency physicians) and other diagnostic tests, rather than a dedicated panel of experts for this specific study's ground truth.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was based on "clinically confirmed" status, suggesting that the initial clinical diagnosis served as the reference standard without a separate adjudication process described for the study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the standalone performance of the device against clinically confirmed specimens.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
Yes, a standalone study was performed. The "Sensitivity and Specificity Study" section directly reports the device's performance (sensitivity, specificity, accuracy) when evaluating clinical specimens, indicating its performance without human interpretation influencing the measurement itself. The device is a rapid qualitative immunoassay, where the test strip provides the result.
7. Type of Ground Truth Used (Test Set)
The ground truth for the test set was based on clinical confirmation of myocardial infarction (positive or negative status) using human serum specimens. This is a form of outcomes data/expert diagnosis from clinical practice.
8. Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This type of immunoassay device is often developed and optimized iteratively through laboratory testing rather than traditional machine learning models requiring large, distinct training sets. The "Sensitivity and Specificity Study" likely refers to a validation set after the device's design was finalized.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set is mentioned, the method for establishing its ground truth is not described. Device development for this type of immunoassay typically involves using known positive and negative controls and spiked samples to optimize reagent concentrations and test parameters during the R&D phase, rather than a formal "training set" with established clinical ground truth in the same way a software algorithm might.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.