(13 days)
The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The COBAS Integra ALP IFCC Gen.2 is a colorimetric assay for the determination of the catalytic activity of alkaline phosphatase in serum or plasma in accordance to the recommended reference method of the International Federation of Clinical Chemists (IFCC). In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by phosphatases into phosphate and p-nitro-phenol. The p-nitro-phenol released is directly proportional to the catalytic ALP activity.
This is an in vitro diagnostic device for quantitative determination, not an AI/ML device. The request asks for details specific to AI/ML device studies that are not applicable here. However, I can still extract the acceptance criteria and the summary of the study proving the device meets them based on the provided text, focusing on performance characteristics relevant to an IVD.
Here's the summary:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Characteristic | Reported Device Performance (COBAS Integra ALP IFCC Gen.2) |
|---|---|
| Intended Use | Quantitative determination of catalytic activity of alkaline phosphatase in human serum and plasma for diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. |
| Method | Colorimetric assay in accordance with the recommended reference method of the International Federation of Clinical Chemistry (IFCC). |
| Sample Type | Serum, Heparin plasma |
| Measuring Range | 2 - 1200 U/L |
| Expected Values (at 37° C) | Adults: Females: 35 - 104 U/L, Males: 40 - 129 U/L |
| Children: 1 day: |
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.