FDA 510K for Alkaline Phosphatase or Isoenzymes Test System
An Alkaline Phosphatase (ALP) Isoenzymes Test System measures the different types of ALP enzyme present in the blood, allowing doctors to pinpoint the origin of an abnormal ALP level, usually indicating issues related to the liver or bones, as different body tissues produce distinct forms of the ALP enzyme (isoenzymes) with slightly different structures; essentially, it helps identify which specific organ is causing an elevated ALP level in the blood
Intended Use of Alkaline Phosphatase or Isoenzymes Test System
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.
For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Alkaline Phosphatase or Isoenzymes Test System
Alkaline Phosphatase or Isoenzymes Test System Device Code and Regulation Number
| # | Product Code | Device | Regulation Description | Regulation Number | Device Class |
| 1 | CIN | Electrophoretic separation of alkaline phosphatase | Alkaline Phosphate or Isoenzymes Test systems | 862.1050 | 2 |
| 2 | CJE | nitrophenyl phosphate, alkaline phosphatase or isoenzymes | |||
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (CIN)
Intended use: The Access Ostase assay is a paramagnetic particle, chemiluminescent immunoassay for use with the Access Immunoassay Systems for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget’s disease
Device Description: The Access Ostase assay is an advanced diagnostic tool for measuring bone alkaline phosphatase (BAP), which serves as an important marker of osteoblastic activity and bone formation. It is especially useful in the management of postmenopausal osteoporosis and Paget’s disease, helping healthcare providers assess bone metabolism and monitor the effectiveness of treatments. The integration with automated Access Immunoassay Systems allows for accurate, high throughput testing with minimal hands-on time, making it an efficient tool in clinical laboratories.
NAD-NADH, Specific Reagent for Alcohol Enzyme Method (DML)
Intended use: The Alkaline Phosphatase assay is used for the quantitation of alkaline phosphatase in human serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are to be used as an aid in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Device Description: The Alkaline Phosphatase assay is an automated clinical chemistry assay. Alkaline phosphatase in the sample catalyzes the hydrolysis of colorless p-nitrophenyl phosphate (p-NPP) to give p-nitrophenol and inorganic phosphate. At the pH of the assay (alkaline), the p-nitrophenol is in the yellow phenoxide form. The rate of absorbance at 404 nm is directly proportional to the alkaline phosphatase activity in the sample. Optimized concentrations of zinc and magnesium ions are present to activate the alkaline phosphatase in the sample
Performance Testing (Analytical) for Alkaline Phosphatase or Isoenzymes Test System
- Precision/Reproducibility
- Linearity
- Detection of limit
- Limit of Blank (LoB
- Limit of Quantitation (LoQ)
- Accuracy
- Analytic sensitivity
The same is applicable for CE Marking under IVDR also.
Clinical Testing
Not Applicable for 510k submission and IVDR CE Marking