(80 days)
Dimension Vista® A2MAC Flex® reagent cartridge: The A2MAC method is an in vitro diagnostic test for the quantitative measurement of a2-macroglobulin in human serum and plasma on the Dimension Vista® Systems. Measurements of a2 -macroglobulin aid in the diagnosis of blood clotting or blood lysis disorders.
Dimension Vista® PROT 1 CAL: PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® Systems for: a1-Acid Glycoprotein (A1AG), a-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), b2-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, IGG-C*), 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) *For cerebrospinal fluid
Dimension Vista® Protein 1 Control L: PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® Systems in the quantitative determination of: a1-Acid Glycoprotein (A1AG), a1-Antitrypsin (A1AT), a2-macroglobulin (A2MAC), C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Haptoglobin (HAPT), Hemopexin (HPX), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin E (IGE), Immunoglobulin G (IGG),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), specialty Albumin (sALB*), soluble Transferrin Receptor (STFR) and Transferrin (TRF). *For serum and plasma
Dimension Vista® Protein 1 Control M and H: PROTI CON M and PROT1 CON H are assayed, mid-level and high level, intralaboratory quality controls for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a2-Acid Glycoprotein (A1AG), a1 -Antitrypsin (A1AT), a]-Macroglobulin (A2MAC), b2 -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),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), specialty Albumin (sALB) and Transferrin (TRF). *For serum and plasma
Dimension Vista® A2MAC Flex® reagent cartridge: 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.
Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid human serum based product containing; ar-acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2 -microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E,, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor and transferrin.
Dimension Vista® Protein 1 Control L: Protein 1 Control L is a multi-analyte, low level liquid human serum based product containing : a1-acid glycoprotein, a1-antitrypsin, a2 -macroglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin,immunoglobulin E, immunoglobulin A, immunoglobulin G, immunoglobulin G Subclass , immunoglobulin G subclass 2. immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein,homocysteine, soluble transferrin receptor and transferrin
Dimension Vista® Protein 1 Control M and H: Protein 1 Control M and H are multi-analyte, mid and high level respectively, liquid human scrum based products containing: aj -acid glycoprotein, a1 -antitrypsin, a2 -macroglobulin, b2microglobulin, C3 complement, C4 complement,ceruloplasmin, haptoglobin, hemopexin, immunoglobulin A, immunoglobulin E, immunoglobulin G, immunoglobulin G Subclass . immunoglobulin G subclass 2, immunoglobulin G subclass 3, immunoglobulin G subclass 4, immunoglobulin M, prealbumin, retinol binding protein, homocysteine, soluble transferrin receptor, and transferrin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dimension Vista® A2MAC Flex® reagent cartridge:
The document describes a medical device, the Dimension Vista® A2MAC Flex® reagent cartridge, and its associated calibrator and controls, which are intended for the quantitative measurement of alpha-2-macroglobulin (A2MAC) in human serum and plasma. The study presented is a method comparison study to demonstrate substantial equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation coefficient close to 1.0 | 0.993 |
| Slope close to 1.0 | 1.042 |
| Intercept close to 0 (or a clinically acceptable bias) | +6.3 mg/dL [+0.063 g/L] |
| Demonstrates correlation and equivalent performance | "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human a2-Macroglobulin assay and the Dimension Vista® A2MAC assay." |
Note: The document does not explicitly state numerical acceptance criteria for slope, intercept, or correlation coefficient. However, in method comparison studies for substantial equivalence, the implicit acceptance criteria are typically a slope statistically close to 1, an intercept statistically close to 0, and a high correlation coefficient (usually >0.975 or >0.98, depending on the analyte and regulatory guidance). The reported performance (slope 1.042, intercept +6.3 mg/dL, correlation 0.993) is stated to demonstrate correlation and equivalent performance. The context of a 510(k) submission implies that these results met the FDA's unstated (or internal) acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 143 samples (n=143)
- Data Provenance: The data used were human serum and plasma samples, with concentrations ranging from 28 - 637 mg/dL. The document does not specify the country of origin or whether the samples were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of study does not utilize experts to establish ground truth in the way an imaging or diagnostic algorithm might. Instead, the "ground truth" for each sample is the quantitative value obtained from the predicate device (Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System). This is a comparison between two instruments/reagents, not a subjective interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study compares quantitative measurements from two automated systems. There is no human adjudication process involved in establishing the "ground truth" for the test set or for managing discrepancies between human readers.
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
No, an MRMC comparative effectiveness study was not conducted. This study compares the performance of a new in vitro diagnostic reagent and system to a predicate device, not the performance of human readers or the impact of AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is a standalone performance study of the Dimension Vista® A2MAC assay. The comparison is between the new device and the predicate device, both operating as automated systems without direct human interpretation in the results generation. Human involvement is limited to sample handling, instrument operation, and data analysis, not diagnostic interpretation of raw data for each test.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for comparison was the quantitative measurement obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human a2-macroglobulin assay on the BN ProSpec® System. This is a reference method comparison.
8. The Sample Size for the Training Set
The document does not specify a training set or its size. This is common for traditional in vitro diagnostic device submissions like this one, as they typically involve analytical performance validation (e.g., method comparison, precision, accuracy) rather than machine learning algorithm development which requires distinct training, validation, and test sets. The assay, calibrator, and controls are likely developed and optimized internally by the manufacturer, but the specific "training set" in an AI/ML context is not disclosed or applicable here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct "training set" with established ground truth in the context of an AI/ML device is not mentioned or relevant to this type of traditional IVD submission. The assay's performance characteristics (linearity, sensitivity, etc.) would have been established during its development using internal methods, but this is not equivalent to "ground truth establishment for a training set" as understood in AI/ML validation studies.
§ 866.5620
Alpha -2-macroglobulin immunological test system.(a)
Identification. Analpha -2-macroglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -2-macroglobulin (a serum protein) in plasma. Measurement ofalpha -2-macroglobulin may aid in the diagnosis of blood-clotting or clot lysis disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.