(34 days)
The LifeSign MI® Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of myoglobin and troponin I in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.
LifeSign MI® Myoglobin/Troponin I is simple one step immunochromatographic test for the rapid, qualitative detection of myoglobin and Troponin I.
I am sorry, but the provided text only contains a 510(k) summary for a medical device called "LifeSign MI® Myoglobin/Troponin I Rapid Test." This summary focuses on establishing substantial equivalence to a predicate device and does not include details about acceptance criteria, study results, or other information typically found in a clinical study report.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and the reported device performance. The document does not describe specific performance metrics or acceptance criteria for the device itself. It mainly compares its features to a predicate device.
- Sample sized used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document is a regulatory submission for substantial equivalence, not a clinical performance study report. It focuses on demonstrating that the new device is "exactly the same" as a previously approved predicate device, with the only change being the removal of specific antibodies.
§ 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.