(24 days)
Not Found
No
The device description and performance studies detail a standard enzymatic assay and calibration method, with no mention of AI or ML techniques.
No.
The device is an in vitro diagnostic test and calibrator used for the quantitative measurement of alkaline phosphatase in human serum and plasma, which aids in the diagnosis and treatment of certain diseases. It does not provide therapy or treatment to a patient.
Yes
The ALPI method is explicitly stated to be "an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma." It also mentions that "Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines a chemical assay and a liquid calibrator, both of which are physical components used in an in vitro diagnostic test. It does not describe software as the primary or sole component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "The ALPI method is an in vitro diagnostic test..." and "ALPI CAL is an in vitro diagnostic product...". It also describes the purpose of the test as being used in the "diagnosis and treatment" of various diseases.
- Device Description: The description details a method for measuring a substance (alkaline phosphatase) in human serum and plasma, which are biological samples. It also describes a calibrator used with this method.
- Performance Studies: The document includes various performance studies (Method Comparison, Serum/Plasma Comparison, Reference Interval, Precision, Linearity, Analytical Specificity/Interferences, Limit of Blank, Limit of Determination and Limit of Quantitation) which are typical for demonstrating the analytical performance of an IVD.
- Predicate Device(s): The mention of predicate devices (K991576 ADVIA® Chemistry Alkaline Phosphatase AMP Method and K061818 Dimension Vista® Alkaline Phosphatase Calibrator) further confirms its classification as an IVD, as predicate devices are used in the regulatory submission process for new IVDs.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
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® 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.
Product codes (comma separated list FDA assigned to the subject device)
CJO, JIT
Device Description
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.
ALP p-NP + AMP + PO4 p-NPP + AMP pH 10.25 Mg/Zn
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 | Alkaline Phosphatase U/L |
|---|---|
| 1 | 0 |
| 2 | 500 |
| 3 | 1000 |
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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Liver, bone, parathyroid, and intestinal.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
Split sample comparison between the Dimension® Alkaline Phosphatase assay and the ADVIA® Chemistry Alkaline Phosphatase AMP assay.
Sample Size: 116 patient samples.
Results: Slope = 1.06, Intercept = -0.4 U/L, Correlation Coefficient (r) = 0.999.
Serum/Plasma Comparison:
Comparison testing of 50 matched serum and lithium heparin plasma samples to demonstrate equivalency between serum and lithium heparin plasma for DM ALPI.
Sample Size: 50 matched samples.
Results: Slope = 1.02, Intercept = -5.08, Correlation Coefficient (r) = 0.999.
Reference Interval (Expected Values):
Samples collected from 132 healthy adults and analyzed with the Dimension® ALPI method.
Sample Size: 132 healthy adults.
Results: Reference interval calculated non-parametrically as 46-116 U/L [0.77 - 1.94 ukat/L].
Precision:
Performed in accordance with CLSI EPS-A2. Samples included 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.
Sample Size: Not explicitly stated for total, but "n=80" for the sample table, likely representing replicates over runs.
Results:
BioRad® Multiqual Assayed QC:
Level 1 (Mean 37 U/L): Repeatability SD 0.6 U/L (1.5%CV), Within-Lab SD 1.6 U/L (4.2%CV).
Level 2 (Mean 157 U/L): Repeatability SD 1.0 U/L (0.6%CV), Within-Lab SD 3.7 U/L (2.3%CV).
Level 3 (Mean 303 U/L): Repeatability SD 3.3 U/L (1.1%CV), Within-Lab SD 7.1 U/L (2.4%CV).
Serum Pools:
Serum Pool 1 (Mean 81 U/L): Repeatability SD 1.1 U/L (1.4%CV), Within-Lab SD 1.8 U/L (2.2%CV).
Serum Pool 2 (Mean 842 U/L): Repeatability SD 5.7 U/L (0.7%CV), Within-Lab SD 13.3 U/L (1.6%CV).
Linearity:
Determined according to CLSI EP-6A.
Sample Size: n = 9 for the linearity plot.
Results: Analytical measurement range determined to be 10 - 1000 U/L. The linearity plot showed y = 0.9868x + 9.7726 with an R-squared value of 0.9992.
Analytical Specificity/Interferences:
Evaluated according to CLSI EP7-A2. Bias exceeding 10% is considered interference.
Results:
Hemoglobin (1000 mg/dL):
§ 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.
0
JUL 2 3 2012
510k Summary
Dimension® Alkaline Phosphatase Flex® reagent cartridge (ALPI) Dimension® 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.
A. 510(k) Number - K121907
B. 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
C. Date: June 28, 2012
D. Proprietary and Established Names:
Dimension® Alkaline Phosphatase Flex® reagent cartridge, (ALPI) Dimension® Alkaline Phosphatase Calibrator (ALPI CAL)
E. 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
F. 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® Alkaline Phosphatase Calibrator (ALPI CAL) is the Dimension Vista® Alkaline Phosphatase Calibrator previously cleared under K061818.
1
G. Device Description:
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.
ALP p-NP + AMP + PO4 p-NPP + AMP pH 10.25 Mg/Zn
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 | Alkaline Phosphatase U/L |
|---|---|
| 1 | 0 |
| 2 | 500 |
| 3 | 1000 |
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.
H. 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® 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.
I. Indication(s) for Use:
Same as Intended Use
J. Substantial Equivalence Information:
Both the Dimension® 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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| Feature | Dimension® Alkaline Phosphatase
Flex® reagent cartridge (DF150) | 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® clinical chemistry
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 | Serum and Lithium Heparin Plasma |
| Measurement | Bichromatic rate | Rate (RRA) |
Similarities for Dimension® ALPI assay:
Differences for Dimension® ALPI assay:
| Feature | Dimension® Alkaline Phosphatase
Flex® reagent cartridge (DF150) | Predicate: ADVIA®
CHEMISTRY® Alkaline
Phosphatase AMP Method K991576 |
|--------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------|
| Measuring
Range | 10 - 1000 U/L | 0 - 1100 U/L |
| Sample Size | 7 µL | 3 µL |
Similarities for Dimension® ALPI Calibrator
| Feature | Dimension® Alkaline Phosphatase
Calibrator ALPI CAL (DC150) | Predicate: Dimension Vista®
Alkaline Phosphatase Calibrator
ALP CAL (KC330) K061818 |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | ALPI CAL is an in vitro diagnostic
product for the calibration of
alkaline phosphatase (ALPI) method
on the Dimension® clinical
chemistry 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 |
.
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Differences for Dimension® ALPI CAL
| Feature | Dimension® Alkaline Phosphatase
Calibrator ALPI CAL (DC150) | Predicate: Dimension Vista®
Alkaline Phosphatase Calibrator
ALP CAL (K330) K061818 |
|--------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Matrix | Human serum albumin based | Bovine protein based |
| Target
Concentrations | Level 1:0 U/L
Level 2: 500 U/L
Level 3: 1000 U/L | Level 2: (CAL A) 1040 U/L
Note: Level 1 is System Water |
| Traceability | IFCC reference method | Masterpool values |
K. 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)
L. Performance Characteristics
The following data represent typical performance for the Dimension® clinical chemistry systems and was collected on a Dimension® RxL.
Method Comparison
Split sample comparison between the Dimension® Alkaline Phosphatase assay and the ADVIA® Chemistry Alkaline Phosphatase AMP assay gave the following correlation statistics, when tested with patient samples:
| Dimension® | Predicate | Slope | Intercept U/L | Correlation
Coefficient (r) | n |
|------------|------------------|-------|---------------|--------------------------------|-----|
| ALPI | ADVIA®
ALPAMP | 1.06 | -0.4 | 0.999 | 116 |
Dimension® Alkaline Phosphatase (ALPI) vs. Predicate
4
Serum/Plasma Comparison
To demonstrate equivalency between serum and lithium heparin plasma for DM ALPI, comparison testing of 50 matched serum and lithium heparin plasma samples were tested on the Dimension® clinical chemistry system and gave the following linear regression statistics:
| Serum vs. | Slope | Intercept U/L | Correlation Coefficient (r) | n |
|---|---|---|---|---|
| Lithium | ||||
| Heparin | ||||
| Plasma | 1.02 | -5.08 | 0.999 | 50 |
Reference Interval (Expected Values)
Samples were collected from 132 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: 46-116 U/L [0.77 - 1.94 ukat/L]
Precision
Precision testing was performed in accordance with CLSI EPS-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 table:
| Repeatability | Within-Lab | ||||
|---|---|---|---|---|---|
| Sample | |||||
| n=80 | Mean (U/L) | SD (U/L) | %CV | SD (U/L) | %CV |
| BioRad® Multiqual Assayed QC | |||||
| Level 1 | 37 | 0.6 | 1.5 | 1.6 | 4.2 |
| Level 2 | 157 | 1.0 | 0.6 | 3.7 | 2.3 |
| Level 3 | 303 | 3.3 | 1.1 | 7.1 | 2.4 |
| Pools | |||||
| Serum Pool 1 | 81 | 1.1 | 1.4 | 1.8 | 2.2 |
| Serum Pool 2 | 842 | 5.7 | 0.7 | 13.3 | 1.6 |
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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 testing and the Limit of Detection testing on the Dimension® clinical chemistry analyzer, the analytical measurement range was determined to be 10 - 1000 U/L.
Image /page/5/Figure/2 description: The image shows a scatter plot titled "DM ALPI Linearity: Observed vs Expected". The x-axis is labeled "Expected ALP Value (U/L)" ranging from 0 to 1400, and the y-axis is labeled "Observed ALP Value (U/L)" ranging from 0 to 1400. A dashed line of best fit is plotted through the data points, and the equation of the line is given as y = 0.9868x + 9.7726, with an R-squared value of 0.9992 and a sample size of n = 9.
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Analytical Specificity/Interferences
The ALPI method was evaluated for interference according to CLSI EP7-A2 Interference Testing in Clinical Chemistry; Approved 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] | 297[4.96] | |