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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.
Ask a specific question about this device
(24 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® 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 0.7Within-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) < 10%. | - Hemoglobin (1000 mg/dL): <10% bias at 297 U/L and 823 U/L.- Bilirubin (unconjugated 80 mg/dL): <10% bias at 300 U/L and 834 U/L.- Bilirubin (conjugated 80 mg/dL): <10% bias at 307 U/L and 856 U/L.- Lipemia (Intralipid® 500 mg/dL): <10% bias at 308 U/L and 878 U/L.- Lipemia (Intralipid® 600 mg/dL): Tripped an error flag; interference could not be determined. Exogenous substances showed <10% bias at 299 U/L and 842 U/L. |
| Limit of Blank (LoB) | Established lowest analyte concentration with no false positives. | LoB: 3 U/L. |
| Limit of Detection (LoD) | Established lowest analyte concentration reliably detected. | LoD: 8 U/L. |
| Limit of Quantitation (LoQ) | Established lowest analyte concentration accurately quantified. | LoQ: 9 U/L. |
Study Details
This document describes performance characteristics typically reported for an in vitro diagnostic device, primarily focused on analytical performance and comparison to a predicate device. It does not appear to involve a study of an AI/ML algorithm or human-in-the-loop performance.
-
Sample sizes used for the test set and the data provenance:
- Method Comparison: 116 patient samples. Data provenance not explicitly stated (e.g., country of origin, retrospective/prospective), but implied to be human patient samples.
- Serum/Plasma Comparison: 50 matched serum and lithium heparin plasma samples. Data provenance not explicitly stated.
- Reference Interval: 132 healthy adults. Data provenance not explicitly stated.
- Precision: Not based on patient samples directly; used three levels of Bio-Rad® Multiqual Assayed Quality Controls and two serum pools.
- Linearity: n=9 samples (based on the figure description). Data provenance not explicitly stated.
- Analytical Specificity/Interferences: Multiple samples tested with specific interferent concentrations (e.g., 2 samples for hemoglobin interference testing, 2 samples for bilirubin).
- Limit of Blank, Limit of Detection, Limit of Quantitation: 5 samples for LoB, 5 low-level samples for LoD, 3 low-level samples diluted for LoQ.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to the device described. The studies measure the device's analytical performance against established laboratory standards and reference methods (e.g., predicate device, CLSI guidelines), not against expert determination of a medical condition. For example, "ground truth" for Alkaline Phosphatase levels comes from the actual concentration measured by a reference method or predetermined controls, not from expert consensus.
-
Adjudication method for the test set:
- This is not applicable as the studies focus on analytical performance and quantitative measurements, not on qualitative interpretations requiring adjudication.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a chemistry analyzer reagent and calibrator kit, not an AI/ML-driven diagnostic tool that would typically involve human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The studies described are for the standalone analytical performance of the in vitro diagnostic device (reagent and calibrator) on a clinical chemistry system. This device is not an algorithm in the sense of AI/ML, but rather a chemical assay. Its performance is evaluated independently of human interpretation of the result it produces, though a human still interprets the clinical significance of that result.
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The type of ground truth used:
- Method Comparison: The predicate device (ADVIA® Chemistry Alkaline Phosphatase AMP assay) served as the comparative "truth" for evaluating the new device's accuracy.
- Serum/Plasma Comparison: Matched serum and lithium heparin plasma samples were used, where the goal was to show equivalence between the two sample types, implying their respective results represent the "truth" for that sample.
- Reference Interval: Results from 132 healthy adults defined the expected range, serving as an epidemiological ground truth for a heathy population.
- Precision: Bio-Rad® Multiqual Assayed Quality Controls and serum pools with known target values served as the ground truth.
- Linearity: Expected ALP values derived from dilution series served as the ground truth.
- Analytical Specificity/Interferences: Control samples (without interferent) and test samples (with known interferent concentrations) were used, with the control samples representing the baseline truth.
- Limit of Blank, Limit of Detection, Limit of Quantitation: Enzyme Diluent (zero level) and specifically prepared low-level samples were used, with the known concentrations serving as the ground truth.
- Overall, the ground truth relies on established reference methods, validated controls, known concentrations, and epidemiological data from healthy populations.
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The sample size for the training set:
- This concept of a "training set" is not applicable. This is a traditional in vitro diagnostic device, not an AI/ML system that requires a training set for model development. The development of the reagents and assay method would involve R&D and optimization, but not in the same sense as training an algorithm on a dataset.
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How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the AI/ML context for this device.
Ask a specific question about this device
(211 days)
The Bayer ADVIA IMS alkaline phosphatase (ALP) assay is an in-vitro diagnostic device intended to measure ALP in human serum or plasma. Such measurements are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This diagnostic method is not intended for use on any other diagnostic system.
This in vitro method is intended to quantitatively measure calcium in human serum and plasma on the Bayer ADVIA IMS. Measurements of calcium are used in the diagnosis, monitoring and treatment of a variety of diseases including parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
The Bayer ADVIA IMS Glucose assay is an in vitro diagnostic device intended to measure glucose in human serum or plasma. Such measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, including diabetes mellitus and neonatal hypoglycemia. This diagnostic method is not intended for use on any other diagnostic system.
The Bayer ADVIA IMS Ferritin assay is an in vitro diagnostic device intended to quantitatively measure ferritin (an iron-storage protein) in human serum. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency. This diagnostic method is not intended for use on any other diagnostic system.
This in viro method is intended to quantitatively measure hCG, human chorionic gonadotropin, in human serum using ADVIA hCG Assay on a Bayer ADVIA® Integrated Modular System. Measurements of hCG are used in the detection of pregnancy. This diagnostic method is not intended for use on any other diagnostic system.
This in viro method is intended to quantitatively measure TSH, Thyroid Stimulating Hormone, in human serum using ADVIA 3d Generation TSH Assay on a Bayer ADVIA® Integrated Modular System. This assay allows the determination of TSH with 3d generation sensitivity of less than 20% total coefficient of variation (CV) at 0.02 µIU/mL, as defined by the American Thyroid Association. Measurements thyroid stimulating hormone are used in the diagnosis of thyroid or pituitary disorders. This diagnostic method is not intended for use on any other diagnostic system.
Not Found
Here's an analysis of the provided text, outlining the acceptance criteria and study details for each assay method on the Bayer ADVIA IMS System. Please note that the document primarily focuses on demonstrating substantial equivalence to a predicate device, which means the "acceptance criteria" are largely implied by the performance of the predicate device and direct comparison studies. There are no explicit, pre-defined acceptance criteria listed as pass/fail thresholds in the provided text, but rather observed performance values used for comparison.
General Observations:
- Device Type: This document describes in-vitro diagnostic devices (assays) for measuring various analytes in human serum or plasma.
- Study Type: The studies described are primarily method comparison studies (correlation, regression) and precision studies, along with interference studies. These are standard for demonstrating substantial equivalence for IVDs.
- Ground Truth: For these types of quantitative assays, the "ground truth" is generally established by the reference method (the predicate device) or by highly controlled laboratory measurements. There isn't an "expert consensus" or "pathology" in the typical sense for these quantitative measurements.
- Human-in-the-loop/MRMC: These concepts are not applicable to the performance evaluation of a quantitative, automated in-vitro diagnostic assay. The device performs the measurement; it's not an AI assisting a human reader in interpretation.
- Data Provenance: The data is implicitly retrospective as it compares the new device's performance to an already cleared predicate. No specific country of origin is mentioned, but Bayer Corporation has its headquarters in the US.
- Ground Truth for Training Set: Since these are largely traditional chemical/immunoassay methods and not AI/ML algorithms in the modern sense (which require a distinct training phase), the concept of a "training set" for an algorithm and how its ground truth was established is not directly applicable. The "development" of such assays involves optimizing reagents and protocols.
1. Alkaline Phosphatase (ALP) Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|
| Analytical Range: 0 to 2250 U/L (Chem 1) | 0 to 2800 U/L |
| Precision (Total %CV): | |
| - At ~65 U/L: 3.8% (Chem 1) | - At 74 U/L: 3.6% |
| - At ~263 U/L: 3.3% (Chem 1) | - At 160 U/L: 2.9% |
| - At ~547 U/L: 3.2% (Chem 1) | - At 420 U/L: 2.1% |
| Regression (vs. Chem 1): (Implied close correlation) | y = 0.96x + 2.0 (r = 0.999, Sy.x = 11.2) |
| Plasma Qualification (vs. Serum): (Implied close correlation) | y = 1.06x - 0.9 (r = 0.999, Sy.x = 0.93) |
| Interference (% Change): (Implied acceptable levels) | |
| - Hemoglobin (500mg/dL): 9% | |
| - Bilirubin (conjugated, 20mg/dL): 8% | |
| - Bilirubin (unconjugated, 25mg/dL): 1% | |
| - Lipemia (Triglycerides, 1000mg/dL): 3% |
Study Details:
- Sample sizes for test set:
- Regression (serum comparison): n = 74
- Regression (plasma qualification): n = 59
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, but likely samples collected from a clinical laboratory setting, retrospective for the purpose of comparison.
- Number of experts and qualifications: Not applicable. These are quantitative chemical assays, not image interpretation.
- Adjudication method: Not applicable. Direct quantitative measurements.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, the performance data provided (analytical range, precision, interference) represents the standalone performance of the ADVIA IMS ALP method. The regression studies compare its standalone performance to another standalone device.
- Type of ground truth: The "ground truth" for the comparative studies is the measurement obtained from the predicate device (Bayer Chem 1 ALP(AMP) method). For interference studies, it is the measurement of the sample without the interfering substance ("neat concentration") or at a known baseline.
- Sample size for training set: Not applicable for this type of IVD (not an AI/ML algorithm requiring a training set).
- Ground truth for training set: Not applicable.
2. Calcium Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|
| Analytical Range: 1 to 15 mg/dL (Chem 1) | 0 to 14.0 mg/dL |
| Precision (Total): | |
| - @ 8.4 mg/dL: 2.3% (Chem 1) | - @ 8.4 mg/dL: 1.1% |
| - @ 10.6 mg/dL: 2.5% (Chem 1) | - @ 10.4 mg/dL: 2.2% |
| - @ 13.4 mg/dL: 2.2% (Chem 1) | - @ 13.6 mg/dL: 0.9% |
| Correlation (vs. Chem 1): (Implied close correlation) | y = 0.96 - 0.8 mg/dL (n=48, r=0.996, Sy.x=0.01 mg/dL) |
| Plasma/Serum Equivalence: (Implied minimal difference) | 0.00 difference at 8.4 mg/dL, 0.75% Within-run CV for plasma vs. 0.73% for serum |
| Interference (% Effect Change): (Implied acceptable levels) | |
| - Bilirubin (unconjugated, 25mg/dL): 1.1% | |
| - Hemoglobin (1000mg/dL): 3.0% | |
| - Triglycerides (500mg/dL): 3.0% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 48
- Plasma/Serum Equivalence: Not explicitly stated, but includes a specific concentration (8.4 mg/dL).
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Technicon CHEM 1 Calcium method) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
3. Glucose Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA IMS) |
|---|---|
| Analytical Range: 0 to 675 mg/dL (Chem 1) | 0 to 800 mg/dL |
| Precision (Total %CV): | |
| - At ~87 mg/dL: 2.7% (Chem 1) | - At 48 mg/dL: 3.66% |
| - At ~262 mg/dL: 2.9% (Chem 1) | - At 97 mg/dL: 3.03% |
| - At ~305 mg/dL: 2.3% (Chem 1) | - At 293 mg/dL: 1.80% |
| - At ~562 mg/dL: 1.3% (Chem 1) | |
| Regression (serum vs. Chem 1): (Implied close correlation) | y = 1.03x + 0.71 (n=58, r=0.993, Sy.x=11.4) |
| Regression (plasma qualification vs. serum): (Implied close correlation) | y = 0.97x + 4.12 (n=60, r=0.943, Sy.x=4.1) |
| Interference (% Change): (Implied acceptable levels) | |
| - Hemoglobin (1000mg/dL): 0.5% | |
| - Bilirubin (conjugated, 25mg/dL): 0.5% | |
| - Bilirubin (unconjugated, 25mg/dL): 1.3% | |
| - Lipemia (Triglycerides, 500mg/dL): 9.5% |
Study Details:
- Sample sizes for test set:
- Regression (serum comparison): n = 58
- Regression (plasma qualification): n = 60
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Bayer Technicon Chem 1 Glucose method) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
4. Ferritin Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA Ferritin) |
|---|---|
| Minimum Detectable Conc.: 0.3 ng/mL (Immuno 1) | 0.06 ng/mL |
| Precision (Total CV%): | |
| - At 21 ng/mL: 7.1% (Immuno 1) | - At 28 ng/mL: 4.1% |
| - At 148 ng/mL: 5.0% (Immuno 1) | - At 108 ng/mL: 4.8% |
| - At 344 ng/mL: 5.0% (Immuno 1) | - At 245 ng/mL: 5.0% |
| Correlation (vs. Immuno 1): (Implied close correlation) | y = 1.040x - 6.132 (n=50, r=0.993, Syx=57.50 ng/mL) |
| Interference (% Change): (Implied acceptable levels) | |
| - Hemoglobin (1000mg/dL): 0.8% | |
| - Bilirubin (27.5mg/dL): 3.5% | |
| - Urea Nitrogen (200mg/dL): 3.8% | |
| - Lipemia (Triglycerides, 1110mg/dL): 4.5% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 50
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Immuno 1 Ferritin assay) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
5. Human Chorionic Gonadotropin (hCG) Method
| Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (ADVIA hCG Assay) |
|---|---|
| Minimum Detectable Conc.: 0.5 mIU/mL (Immuno 1) | 0.1 mIU/mL |
| Precision (Total CV): | |
| - @ 18.3 mIU/mL: 4.0% (Immuno 1) | - @ 12.1 mIU/mL: 4.2% |
| - @ 55.7 mIU/mL: 3.7% (Immuno 1) | - @ 23.9 mIU/mL: 4.5% |
| - @ 198.1 mIU/mL: 3.7% (Immuno 1) | - @ 198.1 mIU/mL: 5.5% |
| Correlation (vs. Immuno 1): (Implied close correlation) | y = 0.99x + 1.96 (n=40, r=1.0, Syx=17.5 mIU/mL) |
| Interference (% Effect): (Implied acceptable levels) | |
| - Hemoglobin (1000 mg/dL): -2.3% | |
| - Lipids (Triglycerides, 1000 mg/dL): -8.7% | |
| - Bilirubin (25 mg/dL): -6.1% | |
| - Urea Nitrogen (200 mg/dL): -7.6% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 40
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Bayer Immuno 1 hCG Assay) for correlation. Known baseline or reference values for precision and interference.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
6. Thyroid Stimulating Hormone (TSH) Method
| Acceptance Criteria (Implied by Predicate Performance and ATA definition) | Reported Device Performance (ADVIA TSH Assay) |
|---|---|
| Minimum Detectable Conc.: 0.03 µIU/mL (Immuno 1) | 0.005 µIU/mL |
| Precision (Total CV): Less than 20% CV at 0.02 µIU/mL | 13.2% @ 0.02 µIU/mL |
| Precision (Total CV) (from Immuno 1): | |
| - @ 1.3 µIU/mL: 6.3% (Immuno 1) | - @ 0.52 µIU/mL: 2.9% |
| - @ 9.0 µIU/mL: 2.0% (Immuno 1) | - @ 4.95 µIU/mL: 2.3% |
| - @ 22.5 µIU/mL: 1.8% (Immuno 1) | - @ 31.10 µIU/mL: 2.6% |
| Correlation (vs. Immuno 1): (Implied close correlation) | y = 0.98x - 0.357 (n=50, r=0.997, Syx=1.48 µIU/mL) |
| Interference (% Effect): (Implied acceptable levels) | |
| - Hemoglobin (1000 mg/dL): 1.8% | |
| - Lipids (Triglycerides, 1000 mg/dL): -0.9% | |
| - Bilirubin (28 mg/dL): (Value missing in document) | |
| - Urea Nitrogen (200 mg/dL): -1.5% |
Study Details:
- Sample sizes for test set:
- Correlation: n = 50
- Interference: Not explicitly stated per interfering substance, but done at specific analyte concentrations.
- Data Provenance: Not specified, likely retrospective clinical samples.
- Number of experts and qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Yes, performance data reflects standalone operation, with correlation against a predicate.
- Type of ground truth: Measurements from the predicate device (Bayer Immuno 1 TSH Assay) for correlation. Known baseline or reference values for precision and interference. The acceptance criterion for sensitivity is also tied to the American Thyroid Association standard.
- Sample size for training set: Not applicable.
- Ground truth for training set: Not applicable.
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