(45 days)
The SPIFE LD test system can be used in conjunction with CK isoenzyme studies to aid in the diagnosis of myocardial infarction. The LD1/LD2 "flip" can be present in patients after acute MI, severe anemias, renal necrosis and in-vivo or in-vitro hemolysis of any cause.
The LD5 is increased in skeletal muscle injury or diseases, cirrhosis, hepatitis and passive liver congestion.
Mid-zone fractions (LD2,3,4) are increased in cases of massive platelet destruction (pulmonary embolism) and in lymphatic system involvements such as mononucleosis, lymphomas and lymphocytic leukemias.
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I am sorry. I cannot answer your question. The document does not contain the information requested in your query. The document is an FDA 510(k) clearance letter for the "SPIFE LD Vis Isoenzyme Kit" and primarily discusses the regulatory approval, classification, and indications for use of the device. It does not provide details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment for performance evaluation.
§ 862.1445 Lactate dehydrogenase isoenzymes test system.
(a)
Identification. A lactate dehydrogenase isoenzymes test system is a device intended to measure the activity of lactate dehydrogenase isoenzymes (a group of enzymes with similar biological activity) in serum. Measurements of lactate dehydrogenase isoenzymes are used in the diagnosis and treatment of liver diseases, such as viral hepatitis, and myocardial infarction.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.