DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
Device Facts
| Record ID | K122323 |
|---|---|
| Device Name | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI |
| Applicant | Siemens Healthcare Diagnostics |
| Product Code | CJO · Clinical Chemistry |
| Decision Date | Aug 28, 2012 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1050 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K122323 · Aug 28, 2012 | DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI | Siemens Healthcare Diagnostics | Healthy adult patient samples | Patient samples were used to establish reference intervals (expected values) for the assay in a healthy population. | Reference Interval; Healthy Adult Population |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Observational cohort (reference interval establishment) | 133 healthy adults; Sample Size: 133 | Not applicable for this study | Reference interval (45-117 U/L) |
Indications for Use
The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension Vista® System. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension Vista® System.
Device Story
The ALPI method is an in vitro diagnostic assay for quantitative measurement of alkaline phosphatase (ALP) in human serum and plasma. The device uses a Flex® reagent cartridge on the automated Dimension Vista® System. Principle of operation: ALP catalyzes transphosphorylation of p-nitrophenylphosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of 2-amino-2-methyl-1-propanol (AMP) buffer, magnesium, and zinc ions. The system measures the change in absorbance at 405 nm (bichromatic 405/510 nm rate technique), which is directly proportional to ALP activity. The ALPI CAL is a liquid, human serum albumin-based calibrator containing porcine kidney ALP used to calibrate the assay. The system is operated by laboratory personnel in clinical settings. Results are used by physicians to diagnose and monitor liver, bone, parathyroid, and intestinal conditions.
Clinical Evidence
Bench testing only. Method comparison study (n=116) against predicate showed correlation coefficient r=0.999, slope 1.05. Serum vs. plasma comparison (n=50) showed r=0.999, slope 1.02. Precision testing (n=80) per CLSI EP5-A2 showed within-lab CVs ranging from 1.8% to 4.1%. Linearity established from 10–1000 U/L. Interference testing per CLSI EP7-A2 showed bias <10% for hemoglobin, bilirubin, and lipemia (up to 400 mg/dL). LoB, LoD, and LoQ determined per CLSI EP17-A.
Technological Characteristics
Reagent: Flex® cartridge containing p-NPP, AMP buffer, Mg/Zn ions. Calibrator: Liquid, human serum albumin-based, porcine kidney ALP. Measurement: Bichromatic rate (405/510 nm). Connectivity: Automated clinical chemistry analyzer. Standards: CLSI EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A, C28-A3.
Indications for Use
Indicated for quantitative measurement of alkaline phosphatase in human serum and plasma to aid diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. For use on Dimension Vista® System.
Regulatory Classification
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.
