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510(k) Data Aggregation
(24 days)
DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension® clinical chemistry 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® clinical chemistry system.
The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitropheny | phosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of the transphosphorylating buffer, 2 amino-2-methyl-1-propanol (AMP). The reaction is enhanced through the use of magnesium and zinc ions. The change in absorbance at 405 nm due to the formation of p-NP is directly proportional to the ALP activity, since other reactants are present in non-rate limiting quantities and is measured using a bichromatic (405, 510 nm) rate technique.
The ALPI CAL is a three (3) level, liquid calibrator. It is packaged as a kit of six vials, two vials per level (1, 2 and 3) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Levels 2 and 3 contain alkaline phosphatase at the following concentrations.
Level 1: 0 U/L
Level 2: 500 U/L
Level 3: 1000 U/L
This product is sold separately from the Flex® reagent cartridge. Values are assigned to new lots from a Masterpool that is from an International Federation of Clinical Chemistry (IFCC) reference.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Criteria (Test) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (r ≈ 1) and minimal bias compared to predicate device. | ALPI vs. ADVIA® ALPAMP: Slope: 1.06; Intercept: -0.4 U/L; Correlation Coefficient (r): 0.999. |
| Serum/Plasma Comparison | Strong correlation (r ≈ 1) and minimal bias between serum and plasma samples. | Serum vs. Lithium Heparin Plasma: Slope: 1.02; Intercept: -5.08 U/L; Correlation Coefficient (r): 0.999. |
| Reference Interval | Established expected range for healthy adults. | Expected Values: 46-116 U/L [0.77 - 1.94 µkat/L] (representing the central 95% of results). |
| Precision (Repeatability & Within-Lab) | Low coefficient of variation (CV%) for various control levels and serum pools. | Repeatability: |
- BioRad QC Level 1: Mean 37 U/L, SD 0.6 U/L, %CV 1.5
- BioRad QC Level 2: Mean 157 U/L, SD 1.0 U/L, %CV 0.6
- BioRad QC Level 3: Mean 303 U/L, SD 3.3 U/L, %CV 1.1
- Serum Pool 1: Mean 81 U/L, SD 1.1 U/L, %CV 1.4
- Serum Pool 2: Mean 842 U/L, SD 5.7 U/L, %CV 0.7
Within-Lab: - BioRad QC Level 1: SD 1.6 U/L, %CV 4.2
- BioRad QC Level 2: SD 3.7 U/L, %CV 2.3
- BioRad QC Level 3: SD 7.1 U/L, %CV 2.4
- Serum Pool 1: SD 1.8 U/L, %CV 2.2
- Serum Pool 2: SD 13.3 U/L, %CV 1.6 |
| Linearity | Analytical measurement range demonstrates linear response. | Analytical measurement range: 10 - 1000 U/L. Scatter plot showed y = 0.9868x + 9.7726 with R-squared = 0.9992. |
| Analytical Specificity/Interferences | Bias due to common interferents (hemoglobin, bilirubin, lipemia)
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