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510(k) Data Aggregation
(23 days)
Rx Only
For in vitro diagnostic use only
The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.
The ALB test is a multilayered, analytical element coated on a polyester support.
For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.
The provided document describes the analytical performance of the VITROS XT Chemistry Products ALB-TP Slides for measuring albumin (ALB) concentration, and its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" for each performance metric in a dedicated table. Instead, performance is demonstrated through studies and compared against established clinical laboratory guidelines (CLSI protocols) or by showing strong correlation to the predicate device. For some metrics, an implied acceptance based on clinical relevance and comparison to the predicate can be inferred.
Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of the studies:
| Performance Metric | Inferred Acceptance Criteria (Contextual) | Reported Device Performance |
|---|---|---|
| Method Comparison | Strong correlation (e.g., correlation coefficient close to 1, slope close to 1, intercept close to 0) with the predicate device, following CLSI EP09-A3. | Correlation for ALB (g/dL):- N: 127- Slope: 1.00- Intercept: -0.03- Correlation Coeff.: 0.999- Test Range: 1.0 - 5.9- Measuring Range: 1.0 - 6.0 |
| Matrix Comparison | Acceptable performance across different sample types (serum, plasma) compared to a reference serum type (red top plastic serum tube), with slopes near 1 and intercepts near 0, demonstrating equivalence. | Regression results vs. Serum Plastic:- Na Hep: Slope 0.96, Intercept 0.098- Li Hep: Slope 0.96, Intercept 0.088- PST: Slope 0.95, Intercept 0.107- SST: Slope 0.99, Intercept 0.033- Serum Glass: Slope 1.00, Intercept -0.007 |
| Precision | Meets performance guidelines for precision (e.g., CLSI EP05-A3), demonstrating low variability (low SD and %CV) across different concentrations and over time (repeatability, within-day, within-lab). Specific criteria for SD/CV are not explicitly given but are generally expected to be within clinically acceptable limits. | Representative Lot Precision (g/dL Albumin):- Mean Conc. 1.6: Repeatability %CV 1.2, Within Lab %CV 1.4- Mean Conc. 2.7: Repeatability %CV 0.9, Within Lab %CV 1.2- Mean Conc. 3.4: Repeatability %CV 0.8, Within Lab %CV 1.1- Mean Conc. 4.1: Repeatability %CV 1.0, Within Lab %CV 1.3- Mean Conc. 4.4: Repeatability %CV 0.7, Within Lab %CV 0.9- Mean Conc. 5.2: Repeatability %CV 0.9, Within Lab %CV 1.2 |
| Detection Limits (LoQ) | LoQ determined based on pre-defined Total Error (TE) goals, with a specific goal of ≤ 0.2 g/dL. | ALB (g/dL):- LOB: 0.24- LOD: 0.27- LOQ: 0.60- Claimed LOQ: 1.0 (This implies the device achieves a tighter LoQ than the claimed range allows) |
| Linearity | Supports the claimed measuring range (1.0 - 6.0 g/dL), demonstrated by a linear response across a wider range (e.g., 0.5 - 7.1 g/dL) with a high correlation (R close to 1) and appropriate slope/intercept. Follows CLSI EP06-A. | ALB:- Measuring Range: 1.0 - 6.0 g/dL- Linear Range: 0.5 - 7.1 g/dL- Least Squares Regression: y = 1.01x - 0.19 with R = 1.00 |
| Specificity (Interference) | Bias < 0.24 g/dL at ~3.6 g/dL albumin and bias < 0.30 g/dL at ~4.5 g/dL albumin for non-interfering substances. Known interferents are identified and qualified. Follows CLSI EP07-A3 and EP37. | *Known Interferences (Bias):**- Dextran 40: 6 g/dL (3.8 g/dL ALB) -> -0.38; 4 g/dL (4.8 g/dL ALB) -> -0.58- Hemoglobin: 300 mg/dL (3.8 g/dL ALB) -> 0.32; 200 mg/dL (4.6 g/dL ALB) -> 0.3747 test substances found not to interfere (bias < 0.24 g/dL or < 0.30 g/dL). |
2. Sample size used for the test set and the data provenance
- Test Set Sample Sizes:
- Method Comparison: 127 patient samples.
- Matrix Comparison: Not explicitly stated as a number of unique patient samples, but various collection devices (serum: glass red top, plastic red top, SST; plasma: Na-heparin, Li-heparin, PST) were evaluated. The comparison used two replicates for the reference serum and two replicates for each feature tube.
- Precision: Patient pools and quality control materials. "80 observations (2 replicates per run, 2 runs per day over 20 days)" were used for the precision study, which implies that a smaller number of initial patient pools were tested multiple times.
- Linearity: A series of seventeen proportionally related admixtures of low and high test fluids were tested in quadruplicate.
- Specificity: Not explicitly stated as a number of unique patient samples; it likely used spiked samples or patient samples with known levels of interferents.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It refers to "patient samples" and "patient pools" but provides no further details on their source.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of albumin. "Ground truth" is established by the analytical method itself (measurement against a reference standard or validated method) rather than by expert consensus on qualitative interpretation of images or clinical findings. The predicate device (VITROS Chemistry Products ALB Slides) serves as the reference for method comparison.
4. Adjudication method for the test set
Not applicable. As this is an IVD device measuring a quantitative analyte, there is no subjective interpretation requiring an adjudication process for a "test set" in the way it would be applied to, for example, image-based diagnostic systems. The performance is assessed by comparing quantitative results against reference methods or established analytical performance criteria.
5. 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
Not applicable. This is an in vitro diagnostic device for quantitative measurement of a biochemical analyte. It does not involve human readers interpreting images or data, nor does it involve AI assistance for such interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, in essence, the performance studies described are for the standalone device (VITROS XT Chemistry Products ALB-TP Slides on the VITROS XT 7600 Integrated System) measuring albumin concentration. The device operates as a laboratory instrument without direct human-in-the-loop interpretation of the measurement itself. Human involvement is in operating the instrument and interpreting the quantitative result in a clinical context, but the device's analytical performance (accuracy, precision, linearity, etc.) is assessed independently.
7. The type of ground truth used
The "ground truth" for the performance studies is primarily established by:
- Comparison to a legally marketed predicate device: The VITROS Chemistry Products ALB Slides (K023875) on the VITROS 5600 Integrated System served as the reference for the method comparison study.
- Reference standards and established analytical methods: Precision, linearity, and detection limit studies rely on the inherent accuracy of the measurement procedure itself against known concentrations (e.g., patient pools, quality control materials, spiked samples, or reference materials).
- Clinical Laboratory Standards Institute (CLSI) protocols: The studies specifically cite adherence to CLSI EP09-A3 (Method Comparison), EP05-A3 (Precision), EP17-A2 (Detection Limits), EP06-A (Linearity), EP07-A3, and EP37 (Interference), which are widely accepted guidelines for validating IVD performance.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning device that requires a "training set" in the conventional sense. It is a traditional in vitro diagnostic chemical assay. Its development involves chemical and engineering principles, not statistical learning from a data set.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
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