(52 days)
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No
The description focuses on standard immunochemical reaction principles and light scattering measurements, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic test for quantitative measurement of Immunoglobulin A, and a calibrator and quality control for this test. It is used to aid in diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the IgA method is an "in vitro diagnostic test" and that "Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines physical components (reagent cartridge, calibrator, controls) and a measurement method based on light scattering, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the IgA method is an "in vitro diagnostic test" and the calibrator and controls are "in vitro diagnostic products."
- Device Description: The description details how the test works by analyzing human body fluids (serum and plasma) in a laboratory setting to measure a specific analyte (Immunoglobulin A).
- Performance Studies: The inclusion of a "Method Comparison Study" is typical for IVD devices to demonstrate performance against a predicate device.
- Predicate Device(s): The listing of predicate devices with K numbers further confirms its classification as an IVD, as this is a requirement for regulatory submissions for IVDs.
The entire context of the document points to a device designed to be used outside of the body to examine specimens for diagnostic purposes.
N/A
Intended Use / Indications for Use
Dimension Vista™ IGA Flex® reagent cartridge:
The IgA method is an in vitro diagnostic test for the quantitative measurement of Immunoglobulin A in human serum and heparinized plasma on the Dimension Vista™ System. Measurements of IgA aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
Dimension Vista™ Protein 1 Calibrator:
PROT1 CAL is an in vitro diagnostic product for the calibration of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) methods on the Dimension Vista™ System.
Dimension Vista™ Protein 1 Control L, Dimension Vista™ Protein 1 Control M and Dimension Vista™ Protein 1 Control H:
For use as an assayed intralaboratory quality control for assessment of precision and analytical bias in the determination of Immunoglobulin A (IGA) and Immunoglobulin G (IGG) on the Dimension Vista™ System.
Product codes (comma separated list FDA assigned to the subject device)
CFN, JJY, JIX
Device Description
Dimension Vista™ IGA 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 calibrator of known concentration.
Dimension Vista™ Protein 1 Calibrator
Protein 1 Calibrator is a liquid, human serum based product containing Immunoglobulin A and Immunoqlobulin G.
Dimension Vista™ Protein 1 Controls L/M/H
Protein Controls L, M and H are multi-analyte, liquid human serum based product containing Immunoglobulin A and Immunoglobulin G.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study
The Dimension Vista™ IgA assay was compared to N Antiserum to Human IgA on the BN ProSpec System by evaluating 50 serum and 50 plasma samples with concentrations ranging from 0.276 to 6.864 g/L. Regression analysis of these results yielded the following equations:
| Dimension Vista™ | 100 | 1.022 | -0.036 | 0.998 |
|---|---|---|---|---|
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
510(k) Summary for Dimension Vista™ IGA Assay
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _