(92 days)
The TRF method is an in vitro diagnostic test for the quantitative measurement of transferrin in human serum, heparinized plasma, EDTA plasma or urine on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: α₁-Acid Glycoprotein (A1AG), α₁-Antitrypsin (A1AT), β₂-Microglobulin (B2MIC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG) [serum/plasma] and (IGG-C) [cerebrospinal fluid], Immunoglobulin G Subclass 1 (IGG1), Immunoglobulin G Subclass 2 (IGG2), Immunoglobulin G Subclass 3 (IGG3), Immunoglobulin G Subclass 4 (IGG4), Immunoglobulin M (IGM), Prealbumin (PREALB), Retinol Binding Protein (RBP), soluble Transferrin Receptor (STFR), Transferrin (TRF) [serum/plasma] and (TRF-U) [urine].
PROT3 CON is an assayed, low level intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the determination of α -Microglobulin (A1MIC), specialty Albumin (sALB*), Immunoglobulin G (IGG -C*), Microalbumin (MALB) and Transferrin (TRF-U**). * For Cerebrospinal fluid (CSF) ** For urine
Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes 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.
Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing q acid glycoprotein, a-antitrypsin, ß2-microglobulin, C3 complement, C4 complement, ceruloplasmin, haptoglobin, hemopexin, homocystine, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G subclass 1, immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, soluble transferrin receptor and transferrin.
Protrein 3 Control is a multi-analyte, lyophilized, polygeline and rabbit plasma albumin based product containing a - Microglobulin, albumin, immunoglobulin G and transferrin.
Here's a breakdown of the acceptance criteria and study information for the Siemens Healthcare Diagnostics Inc. 510(k) Notification for the Dimension Vista® System TRF Flex® reagent cartridge, Protein 1 Calibrator, and Protein 3 Control, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on establishing substantial equivalence through a method comparison study. It does not explicitly state pre-defined acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy against a gold standard, or specific numerical targets for regression analysis. Instead, the "acceptance criteria" can be inferred as achieving a strong correlation and suitable regression statistics (slope, intercept, correlation coefficient) when compared to the legally marketed predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Strong correlation with predicate device (Dade Behring N Antisera to Human Transferrin on BN ProSpec® System) for Transferrin (TRF) measurements in urine. | Regression Analysis: Equation provided: (Specific regression equation not fully legible in the provided text, but mentioned as having been performed). |
| Suitable regression statistics (slope, intercept, correlation coefficient) demonstrating substantial equivalence. | Demonstrated substantial equivalence based on correlation studies and provided information. |
| The modified Dimension Vista® System TRF assay, Protein 1 Calibrator, and Protein 3 Control are substantially equivalent to the legally marketed devices. | Conclusion states that the devices are substantially equivalent based on the correlation studies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The study evaluated urine samples with concentrations ranging from 2.0 to 24.4 mg/L. The exact number of samples is not explicitly stated in the provided text.
- Data Provenance: The text does not specify the country of origin of the data. The study appears to be prospective in nature, comparing the new device against an existing one in a method comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The "ground truth" here is not established by expert consensus on clinical interpretation, but rather by the measurements obtained from the legally marketed predicate device. This is a measurement device comparison, not a diagnostic interpretation device.
4. Adjudication Method for the Test Set
This is not applicable as the study is a method comparison of quantitative measurements, not a diagnostic interpretation that typically involves adjudication of reader disagreements.
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
This is not applicable. The device is an in vitro diagnostic (IVD) reagent and calibrator/control system for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a standalone measurement system (reagent, calibrator, control used on an automated analyzer). The comparison study implicitly tests the standalone performance of the Dimension Vista® System TRF assay against the predicate device. The performance data presented directly reflects the algorithmic (or analytical) output of the device.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurements obtained from the legally marketed predicate device: the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System. This is a form of comparative analytical performance against an established method.
8. The Sample Size for the Training Set
This is not applicable. This submission describes an in vitro diagnostic test system (reagent, calibrator, control). These types of devices do not typically involve "training sets" in the same way machine learning algorithms do. The development of the assay would involve internal optimization and validation, but not a distinct "training set" for an algorithm in the sense of AI.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of IVD device submission.
§ 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).