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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/L
Linearity 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
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(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 0.7
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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(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.
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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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