(27 days)
ADVIA® Chemistry Alkaline Phosphatase AMP assay (predicate).
No
The device description and performance studies focus on a standard enzymatic assay for measuring alkaline phosphatase, with no mention of AI or ML techniques for data analysis, interpretation, or control.
No.
This device is an in vitro diagnostic test and calibrator used for measuring alkaline phosphatase levels, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "The ALPI method is an in vitro diagnostic test for the quantitative measurement 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."
No
The device is an in vitro diagnostic test and calibrator, which are physical reagents used in a laboratory setting. It is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The ALPI method is an in vitro diagnostic test..." and "ALPI CAL is an in vitro diagnostic product...".
- Purpose: The device is intended for the quantitative measurement of alkaline phosphatase in human serum and plasma, which are biological samples taken in vitro (outside the body).
- Clinical Use: The results of the test are used in the "diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases," indicating a clinical diagnostic purpose.
- Device Description: The description details a chemical reaction performed on a sample to obtain a measurement, which is characteristic of an in vitro diagnostic test.
- Calibration: The inclusion of a calibrator (ALPI CAL) is typical for quantitative IVD tests to ensure accurate measurements.
N/A
Intended Use / 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.
Product codes
CJO, JIT
Device Description
The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitrophenylphosphate (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.
p-NPP + AMP ------pH 10.25, Mg/Zn------> p-NP + AMP + PO4
The ALPI CAL is a one (1) level, liquid calibrator. It is packaged as a kit of three vials of Calibrator A (Level 2) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Level 1 is a zero level (system water). Level 2 contains alkaline phosphatase at 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison: Split sample comparison between the Dimension Vista® Alkaline Phosphatase assay and the ADVIA® Chemistry Alkaline Phosphatase AMP assay (predicate). Sample size: 116 patient samples. Key results: Slope = 1.05, Intercept = -0.4 U/L, Correlation Coefficient (r) = 0.999.
Serum/Plasma Comparison: To demonstrate equivalency between serum and lithium heparin plasma for Dimension Vista® ALPI. Sample size: 50 matched serum and lithium heparin plasma samples. Key results: Linear regression statistics: Slope = 1.02, Intercept = -7.7 U/L, Correlation Coefficient (r) = 0.999.
Reference Interval (Expected Values): Samples collected from 133 healthy adults. The reference interval was calculated non-parametrically and represents the central 95% of results determined from the population. Expected Values: 45-117 U/L [0.75 – 1.95 µkat/L].
Precision: Performed in accordance with CLSI EP5-A2. Samples consisted of three levels of Bio-Rad® Multiqual Assayed Quality Controls and two serum pools. Tested over 20 days, two separate runs with two test samples for each material.
Linearity: Determined according to CLSI EP-6A. The analytical measurement range was determined to be 10 – 1000 U/L. The graph for "Vista ALPI Linearity Assessment with High Serum Pool" shows a line of best fit y = 1.010x + 3.461 with R-squared of 0.999.
Analytical Specificity/Interferences: Evaluated according to CLSI EP7-A2. Bias exceeding 10% is considered interference. Hemoglobin (1000 mg/dL), Bilirubin (unconjugated 60 mg/dL), and Bilirubin (conjugated 60 mg/dL) showed
§ 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.
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510k Summarv
Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI) Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL)
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1. 510(k) Number K122323
2. Applicant: Rose T. Marinelli Siemens Healthcare Diagnostics, Inc. P.O. Box 6101, Newark, DE 19714-6101 Office Number: 302-631-8805; Fax Number: 302-631-6299
- Date: July 31, 2012
4. Proprietary and Established Names:
Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge, (ALPI) Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL)
5. Regulatory Information:
Alkaline Phosphatase (ALPI) Flex® reagent cartridge
Regulation section: 21 CFR 862.1050 Alkaline phosphatase or isoenzymes test system Classification: Class II Product Code: CJO Panel: Clinical Chemistry
Alkaline Phosphatase Calibrator (ALPI CAL)
Regulation section: 21 CFR 862.1150 Calibrator, Secondary . Classification: Class II Product Code: JIT Panel: Clinical Chemistry
6. Predicate Devices:
The predicate device used to demonstrate substantial equivalence to the Dimension® Alkaline Phosphatase (ALPI) Flex® reagent cartridge is the ADVIA® Chemistry Alkaline Phosphatase AMP Method previously cleared under K991576.
The predicate device used to demonstrate substantial equivalence to the Dimension Vista® Alkaline Phosphatase Calibrator (ALPI CAL) is the Dimension Vista® Alkaline Phosphatase Calibrator previously cleared under K061818.
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7. Device Description:
The ALPI method employs alkaline phosphatase that catalyzes the transphosphorylation of pnitrophenylphosphate (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.
$$\text{p-NPP} + \text{AMP} \qquad \xrightarrow[\begin{array}{c} \text{pH} \ 10.25\ \text{p-NP} \ \text{10.25} \ \text{Mg/Zn} \end{array}} \qquad \text{p-NP} + \text{AMP} + \text{PO}_4$$
The ALPI CAL is a one (1) level, liquid calibrator. It is packaged as a kit of three vials of Calibrator A (Level 2) with 1.0 mL per vial. The product matrix is a human serum albumin based product containing alkaline phosphatase from porcine kidney. Level 1 is a zero level (system water). Level 2 contains alkaline phosphatase at 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.
8. Intended 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.
9. Indication(s) for Use:
Same as Intended Use
10. Substantial Equivalence Information:
Both the Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI) assay and the predicate ADVIA® Chemistry Alkaline Phosphatase AMP assay employ prepackaged reagents for use on an automated clinical chemistry test systems. A comparison of the similarities and differences between the devices is provided in the following tables:
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Similarities for Dimension Vista® ALPI assay:
| Feature | Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge
Predicate: ADVIA® Chemistry Alkaline Phosphatase AMP K991576 |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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.
For in vitro diagnostic use in the quantitative determination of alkaline phosphatase in human serum and plasma on the ADVIA® Chemistry systems. Such measurements are used in the diagnosis and treatment of hepatobiliary and bone disease. |
| Sample Type | Serum and Lithium Heparin Plasma |
| Measurement | Bichromatic rate
Rate (RRA) |
the state of the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the state
Differences for Dimension Vista® ALPI assay:
| Feature | Dimension Vista® Alkaline
Phosphatase Flex® reagent cartridge | Predicate: ADVIA® Chemistry
Alkaline Phosphatase AMP Method
K991576 |
|--------------------|------------------------------------------------------------------|---------------------------------------------------------------------------|
| Measuring
Range | 10 - 1000 U/L | 0 - 1100 U/L |
| Sample Size | 3.48 µL | 3 µL |
Similarities for Dimension Vista® ALPI Calibrator
| Feature | Dimension Vista® Alkaline
Phosphatase Calibrator ALPI CAL | Predicate: Dimension Vista®
Alkaline Phosphatase Calibrator
ALP CAL K061818 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ALPI CAL is an in vitro diagnostic
product for the calibration of
alkaline phosphatase (ALPI) method
on the Dimension Vista® System. | The ALP CAL is an in vitro
diagnostic product for the
calibration of Alkaline Phosphatase
(ALP) method on the Dimension
Vista® System. |
| Preparation | Liquid:
Provided ready to use. | Liquid:
Provided ready to use. |
| Storage | 2 – 8 °C | 2 – 8 °C |
| Target
Concentrations | Level 2 (CAL A): 1000 U/L
Note: Level 1 is System Water | Level 2: (CAL A) 1000 U/L
Note: Level 1 is System Water |
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Differences for Dimension Vista® ALPI CAL
| Feature | Dimension Vista® Alkaline
Phosphatase Calibrator ALPI CAL | Predicate: Dimension Vista®
Alkaline Phosphatase Calibrator
ALP CAL K061818 |
|--------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Matrix | Human serum albumin based | Bovine protein based |
| Traceability | IFCC reference method | Masterpool values |
11. Standard/Guidance Document Reference:
- · Evaluation of Precision Performance of Quantitative Measurement in Methods; Approved Guideline (EP5-A2)
- · Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approach; Approved Guideline (EP6-A)
- · Interference Testing in Clinical Chemistry; Approved Guideline (EP7-A2)
- · Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A2)
- · Protocols for Determination of Limits of Detection and Quantitation; Approved Guideline (EP17-A)
- · Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline (C28-A3)
12. Performance Characteristics
The following data represent typical performance for the Dimension Vista® System and were collected on a Dimension Vista® 500.
Method Comparison
Split sample comparison between the Dimension Vista® Alkaline Phosphatase assay and the ADVIA® Chemistry Alkaline Phosphatase AMP assay gave the following correlation statistics, when tested with patient samples:
| Dimension
Vista® | Predicate | Slope | Intercept U/L | Correlation
Coefficient (r) | n |
|---------------------|------------------|-------|---------------|--------------------------------|-----|
| ALPI | ADVIA®
ALPAMP | 1.05 | -0.4 | 0.999 | 116 |
Dimension® Alkaline Phosphatase (ALPI) vs. Predicate
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Serum/Plasma Comparison
To demonstrate equivalency between serum and lithium heparin plasma for Dimension Vista® ALPI, comparison testing of 50 matched serum and lithium heparin plasma samples were tested on the Dimension Vista® System and gave the following linear regression statistics:
| Serum vs. | Slope | Intercept U/L | Correlation
Coefficient (r) | n |
|------------------------------|-------|---------------|--------------------------------|----|
| Lithium
Heparin
Plasma | 1.02 | -7.7 | 0.999 | 50 |
Serum vs. Plasma Comparison Data
Reference Interval (Expected Values)
Samples were collected from 133 healthy adults and analyzed with the Dimension® ALPI method. The reference interval was calculated non-parametrically and represents the central 95% of results determined from the population.
Expected Values: 45-117 U/L [0.75 – 1.95 µkat/L]
Precision
Precision testing was performed in accordance with CLSI EP5-A2 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition. Samples consisted of three levels of Bio-Rad® Multiqual Assayed Quality Controls and two serum pools. Testing was performed over 20 days, two separate runs with two test samples for each test material. Analysis of variance (ANOVA) was used to evaluate the data consistent with the recommendations of EP5-A2. The data are summarized in the following Dimension Vista® Alkaline Phosphatase (ALPI) Summary Table:
| Mean (U/L) | Repeatability | Within-Lab | |||
|---|---|---|---|---|---|
| Sample n=80 | SD (U/L) | %CV | SD | ||
| (U/L) | %CV | ||||
| BioRad® Multiqual Assayed QC | |||||
| Level l | 34 | 1.0 | 2.9 | 1.4 | 4.1 |
| Level 2 | । રેર | 1.9 | 1.2 | 3.1 | 2.0 |
| Level 3 | 301 | 4.0 | 1.3 | 4.6 | ાં 'રે |
| Pools | |||||
| Serum Pool 1 | 78 | 1.3 | 1.7 | 1.5 | 1.9 |
| Serum Pool 2 | 833 | । 3.6 | 1.6 | 15.0 | 1.8 |
Linearity
The linear range was determined according to CLSI EP-6A, Evaluation of the Linearity of Quantitative Measurement Procedures; A Statistical Approved Guideline. Based on the results of this
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testing and the Limit of Detection testing on the Dimension Vista® System, the analytical measurement range was determined to be 10 – 1000 U/L.
Image /page/5/Figure/1 description: The image shows a graph titled "Vista ALPI Linearity Assessment with High Serum Pool". The x-axis is labeled "Expected ALPI Concentration (U/L)" and ranges from 0 to 1200. The y-axis is labeled "Observed ALPI Concentration (U/L)" and ranges from 0 to 1200. A line of best fit is plotted on the graph, and the equation of the line is y = 1.010x + 3.461, with an R-squared value of 0.999.
Analytical Specificity/Interferences
The ALPI method was evaluated for interference according to CLSI EP7-A2 Interference Testing in The Ferrance The over as over wed Guideline - Second Edition. Bias is the difference in the results between the control sample (without the interferent) and the test sample (contains the interferent) expressed in percent. Bias exceeding 10% is considered interference.
| Substance Tested | Substance Concentration | Alkaline Phosphatase
U/L [µkat/L] | Bias
% |
|-----------------------------|--------------------------|--------------------------------------|------------|
| Hemoglobin
(hemolysate) | 1000 mg/dL [0.62 mmol/L] | 278 [4.641]
787 [13.14] |