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510(k) Data Aggregation
(27 days)
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.
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 -> p-NP + AMP + PO4 (reaction conditions: pH 10.25, Mg/Zn)
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.
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® Alkaline Phosphatase Flex® reagent cartridge (ALPI) and Calibrator (ALPI CAL), based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied by Predicate/Guideline) | Reported Device Performance (Dimension Vista® ALPI) |
|---|---|---|
| Method Comparison | Demonstrated substantial equivalence to predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) with acceptable correlation statistics (slope near 1, intercept near 0, high correlation coefficient). While specific numerical acceptance criteria for slope, intercept, and 'r' aren't explicitly stated as "acceptance criteria," the predicate comparison aims to show the new device performs similarly. | Slope: 1.05 |
| Serum/Plasma Comparison | Demonstrated equivalency between serum and lithium heparin plasma with acceptable linear regression statistics (slope near 1, intercept near 0, high correlation coefficient). | Slope: 1.02 |
| Reference Interval | Establishment of a clinically appropriate reference interval for healthy adults. | 45-117 U/L [0.75 – 1.95 µkat/L] |
| Precision | Consistent and reproducible results across various levels, as evaluated by CLSI EP5-A2 with acceptable repeatability and within-lab standard deviation (SD) and coefficient of variation (%CV). No explicit numerical acceptance criteria for %CV or SD are provided, but the presented data demonstrates good precision with low CVs. | Repeatability:- Level 1: 1.0 U/L (2.9% CV)- Level 2: 1.9 U/L (1.2% CV)- Level 3: 4.0 U/L (1.3% CV)- Serum Pool 1: 1.3 U/L (1.7% CV)- Serum Pool 2: 13.6 U/L (1.6% CV)Within-Lab:- Level 1: 1.4 U/L (4.1% CV)- Level 2: 3.1 U/L (2.0% CV)- Level 3: 4.6 U/L (Not legible in original doc)- Serum Pool 1: 1.5 U/L (1.9% CV)- Serum Pool 2: 15.0 U/L (1.8% CV) |
| Linearity/Measuring Range | Established linear range according to CLSI EP-6A, ensuring accurate measurements within the stated range. The curve fit (R-squared) should show high linearity. | 10 - 1000 U/LLinearity Assessment: y = 1.010x + 3.461, R-squared = 0.999 |
| Analytical Specificity/Interferences | Bias due to interferents (hemoglobin, bilirubin, lipemia) should be less than 10%. | Bias < 10% for all tested concentrations of Hemoglobin, Bilirubin (unconjugated and conjugated), and Lipemia (up to 400 mg/dL). (Lipemia at 500 mg/dL tripped a test report message, interference could not be determined). |
| Limit of Blank (LoB) | LoB value should be close to zero or negative, indicating minimal signal from blank samples. | -0.2 U/L |
| Limit of Detection (LoD) | LoD value should be low, indicating the lowest concentration reliably detected. | 1 U/L |
| Limit of Quantitation (LoQ) | LoQ value should be low, indicating the lowest concentration at which quantitative results can be reported with a stated accuracy. | 8 U/L |
| Calibrator Stability | Established stability for opened and unopened calibrator for specific durations and storage conditions. | Opened (on system): 7 daysOpened (recapped, 2-8°C): 30 daysShelf Life (unopened): 12 months |
Study Information:
2. Sample Size Used for the Test Set and Data Provenance:
- Method Comparison: 116 patient samples. Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but it is implied to be clinical patient samples.
- Serum/Plasma Comparison: 50 matched serum and lithium heparin plasma samples. Data provenance is not explicitly stated.
- Reference Interval: 133 healthy adults. Data provenance is not explicitly stated.
- Precision:
- 3 levels of Bio-Rad® Multiqual Assayed Quality Controls
- 2 serum pools
- Linearity: Not explicitly stated, but likely used serially diluted samples or spiked samples.
- Analytical Specificity/Interferences: Not explicitly stated for each interferent, but the study used control samples and test samples for ALPI concentrations of either 278/787, 269/804, 268/799, or 298/849 U/L depending on the interferent.
- LoB, LoD, LoQ:
- LoB: 5 samples of Enzyme Diluent (zero level)
- LoD: 5 low-level samples
- LoQ: 3 low-level samples diluted with enzyme diluent
All studies are typical for in vitro diagnostic (IVD) device validation and would generally be considered prospective studies on the new device, comparing it to an established predicate or against defined analytical targets. The summary does not specify the country of origin of the samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This 510(k) summary describes an in vitro diagnostic assay for measuring alkaline phosphatase. The "ground truth" for such assays typically refers to the true concentration or activity of the analyte in a sample.
- No human experts were used to establish "ground truth" for individual test samples in the typical sense of a diagnostic interpretation. Instead, the existing, previously cleared predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the reference for method comparison studies (i.e., its results were considered the "truth" against which the new device was compared).
- For the Calibrator ALPI CAL, the summary states that "Calibrator value assignments for anchor pools were assigned by a reference laboratory using the IFCC reference method." The IFCC (International Federation of Clinical Chemistry and Laboratory Medicine) reference method is a highly standardized, internationally recognized method considered a "gold standard" for accuracy. This implies the expertise lies in the adherence to this reference method rather than individual expert readers.
4. Adjudication Method for the Test Set:
Not applicable. This is not a study requiring adjudication of expert interpretations (e.g., medical imaging reviews). The performance is evaluated based on quantitative analytical results measured by the device and compared to reference methods or statistical targets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretive aid that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes. All performance characteristics described (Method Comparison, Precision, Linearity, Interference, LoB/LoD/LoQ) represent the standalone performance of the Dimension Vista® ALPI assay (the algorithm/reagent system) without human interpretive input. The human involvement is limited to operating the instrument, loading samples, and interpreting the numerical output.
7. The Type of Ground Truth Used:
- For Method Comparison: The results from the predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the comparative "ground truth" to demonstrate substantial equivalence.
- For Calibrator Value Assignment: The IFCC reference method (International Federation of Clinical Chemistry and Laboratory Medicine) was used for assigning values to anchor pools, which then propagated to masterpools and commercial lots. This is a highly standardized, traceable method considered a gold standard for analytical accuracy.
- For other analytical studies (Precision, Linearity, LoD/LoQ): The "ground truth" is typically established by carefully prepared samples with known concentrations or by statistical methods inherent to the CLSI guidelines followed.
8. The Sample Size for the Training Set:
This summary does not explicitly mention a "training set" in the context of machine learning. For IVD devices, validation studies (like those listed) are used to characterize performance. The "training" of an IVD assay refers to the development and optimization of the reagent formulation, instrument parameters, and calibration curve, which is an internal process for the manufacturer. The summarized studies are performance validation studies used to demonstrate the device meets its intended use and is safe and effective.
9. How the Ground Truth for the Training Set Was Established:
Not applicable as there is no mention of a distinct "training set" in a machine learning sense for this IVD assay. The development process for the reagent and assay involves various internal studies and optimizations by the manufacturer to achieve the desired analytical performance. The most relevant form of "ground truth" in the development context would be highly characterized reference materials and reference methods (like the IFCC method for calibration) used to optimize the assay's accuracy and precision.
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