(24 days)
No
The summary describes a standard enzyme immunoassay (ELISA) for detecting antibodies. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies are based on comparison to a predicate ELISA, not on training or testing AI/ML models.
No
This device is for in vitro diagnostic use, detecting antibodies to aid in the diagnosis of autoimmune diseases, not for treating them.
Yes
The "Intended Use / Indications for Use" states that the test system is for "in vitro diagnostic use for the detection of antibodies to nuclear antigens" and that "The results from this assay can be used as an aid in the diagnosis of autoimmune diseases."
No
The device description clearly states it is an "enzyme immunoassay," which is a laboratory test involving physical reagents and processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "This test system is for in vitro diagnostic use". It also describes the purpose of the test as detecting antibodies in human serum to aid in the diagnosis of autoimmune diseases, which is a typical IVD function.
- Device Description: Describes an "enzyme immunoassay for the detection of antibodies... in human serum," which is a common method used in IVD tests.
- Performance Studies: The description of performance studies comparing it to a predicate device (K935129) and providing metrics like sensitivity, specificity, and overall agreement are standard for demonstrating the performance of an IVD.
- Predicate Device(s): The mention of a predicate device with a K number (K935129) indicates that this device is being compared to a previously cleared IVD.
All of these elements strongly indicate that this device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum. The results from this assay can be used as an aid in the diagnosis of autoimmune diseases.
Product codes
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Device Description
This is an enzyme immunoassay for the detection of antibodies to extractable nuclear antigens Sm, RNP, SS-A/RO, SS-B/La, Scl-70, or Jo-1 in human serum.
Mentions image processing
Not Found
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)
For direct determination of relative sensitivity and specificty, we used the Immuno Concepts RELISA® Multiparameter ENA Screening Assay (K935129) as a reference method.
Results:
Immuno Concepts RELISA® Multiparameter ENA Screening Test
Positive: 126 Negative: 9 Borderline: 5
Immuno Concepts RELISA® Single Well ENA Screening Test
Positive
Borderline: 0 Negative: 2 Borderline: 4
Negative: 1 Negative: 2 Negative: 394
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
If we consider borderline results to be positive, these data yield the following statistics: relative sensitivity, 97.9%; relative specificity, 97.8%; and overall agreement, 97.8%
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Immuno Concepts. The logo consists of two horizontal lines on the left, followed by a stylized "IC" symbol. To the right of the symbol is the word "immuno" in a sans-serif font, stacked above the word "concepts" in the same font. The logo is black and white.
SEP 13 1996