(103 days)
Dimension Vista™ STFR Flex® reagent cartridge: The STFR method is an in vitro diagnostic test for the quantitative determination of soluble transferrin receptor in human serum and heparinized plasma on the Dimension Vista System. Measurements of soluble transferrin receptor aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Dimension Vista™ Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Soluble Transferrin Receptor (STFR), methods on the Dimension Vista System.
Dimension Vista™ Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 complement (C3), C4 complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and soluble transferrin receptor (STFR) on the Dimension Vista System.
Dimension Vista™ STFR Flex reagent cartridge: Polystyrene particles coated with monoclonal antibodies specific to human soluble transferrin receptor are aggregated when mixed with samples containing soluble transferrin receptor. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Dimension Vista™ Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liguid, human serum based product containing C3 Complement, C4 Complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and Soluble Transferrin Receptor (STFR).
Dimension Vista™ Protein 1 Control L. M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoqlobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) and soluble transferrin receptor (STFR).
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista™ STFR Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes a method comparison study between the new device and a legally marketed predicate device. The acceptance criteria are implicitly defined by the reported regression analysis results, which demonstrate a strong correlation and "equivalent performance" to the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Dimension Vista™ STFR Flex® compared to N Latex sTFR on BN ProSpec® System) |
|---|---|
| Strong correlation | Correlation Coefficient: 0.997 |
| Slope close to 1 | Slope: 1.053 |
| Intercept close to 0 | Intercept: -0.078 mg/L |
| Equivalent performance | "These studies demonstrate correlation and equivalent performance" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 153 serum and plasma samples.
- Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that "serum and plasma samples with concentrations ranging from 0.21 mg/L to 4.13 mg/L" were evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given summary. The ground truth in this context is implicitly established by the measurements obtained from the predicate device (Dade Behring N Latex sTFR assay on the BN ProSpec® System).
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the given summary. The study is a quantitative method comparison between two automated diagnostic devices, not a study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a method comparison between two in vitro diagnostic (IVD) devices for quantitative measurement of an analyte, not a study involving human readers or interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The study directly assesses the performance of the Dimension Vista™ STFR assay on the Dimension Vista System against a predicate device, without involving human interpretation or modifications to the results.
7. The Type of Ground Truth Used
The "ground truth" for this study was established through the measurements obtained from the legally marketed predicate device, the Dade Behring N Latex sTFR assay on the BN ProSpec® System. This is a common practice in IVD device submissions to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided in the given summary. The document describes a comparison study for the finalized device, not the development or training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given summary, as the submission focuses on the performance of the final device rather than its developmental stages or training data.
§ 866.5880 Transferrin immunological test system.
(a)
Identification. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.(b)
Classification. Class II (performance standards).