(133 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 direct comparison to a predicate ELISA, not on training or testing AI/ML models.
No
This device is an in vitro diagnostic test system designed for the detection of antibodies in human serum, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum."
No
The device description explicitly states it is an "enzyme immunoassay," which is a laboratory test method involving biological reagents and physical processes, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum."
This statement directly identifies the device as being intended for diagnostic purposes performed outside of the living body (in vitro).
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 (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.
Product codes
Not Found
Device Description
This is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
For direct determination of relative sensitivity and specificity, we used the Immuno Concepts RELISA® Screening Assay (K935129) as a reference method.
Key Metrics
Table 1. Detection of antibodies to the Sm autoantigen.
- Relative sensitivity: 100.0%
- Relative specificity: 100.0%
- Overall agreement: 100.0%
Table 2. Detection of antibodies to the RNP autoantigen.
- Relative sensitivity: 100.0%
- Relative specificity: 100.0%
- Overall agreement: 100.0%
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for Immuno Concepts. The logo consists of two horizontal lines on the left, followed by the letters "IC" with the "I" being a thick vertical line and the "C" being a circle with two smaller circles inside. To the right of the "IC" is the word "immuno" stacked on top of the word "concepts".
APR 1 9 1996
Date Prepared: December 4, 1995 Contact Person: Eric S. Hoy, Ph.D. Name of Device:
- · Trade Name RELISA® Sm/RNP Antibody Test System
- · Common Name Sm/RNP Antibody Test System
- Classification Name Extractable Antinuclear Antibody (21 CFR 866.5100)
Legally marketed device with which this device has been shown to be equivalent: RELISA® ENA Antibody Screening Tests System, K935129
Description:
This is an enzyme immunoassay for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.
Intended Use:
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens Sm (Smith) and RNP (U1-RNP or ribonucleoprotein) in human serum.
Summary of Technological Characteristics Compared to the Predicate Device:
This device is identical to the predicate device with the following exceptions :
The predicate device has six different autoantigens coated on individual a) microwells; the present device has only Sm (Smith) or the Sm/RNP (Smith/ribonucleoprotein) complex autoantigen coated on the microwells. b) The predicate device includes a procedure control well on each strip of microwells, the present device includes a calibrator serum in the kit.
Description of Laboratory Data That Indicate Substantial Equivalence:
For direct determination of relative sensitivity and specificty, we used the Immuno Concepts RELISA® Screening Assay (K935129) as a reference method. The data obtained in this comparison are shown in the following Tables.
1
K 955604
| | | Immuno Concepts RELISA® Screening Assay
Positive | Borderline | Negative |
|-----------------------------------|------------|-----------------------------------------------------|------------|----------|
| Immuno Concepts
RELISA® Sm/RNP | Positive | 32 | 0 | 0 |
| | Borderline | 0 | 4 | 0 |
| | Negative | 0 | 0 | 102 |
Table 1. Detection of antibodies to the Sm autoantigen.
These data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 100.0%; and overall agreement, 100.0%
Table 2. Detection of antibodies to the RNP autoantigen.
| | | Positive | Immuno Concepts RELISA® Screening Assay
Borderline | Negative |
|-----------------------------------|------------|----------|-------------------------------------------------------|----------|
| Immuno Concepts
RELISA® Sm/RNP | Positive | 40 | 0 | 0 |
| | Borderline | 0 | 5 | 0 |
| | Negative | 0 | 0 | 93 |
These data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 100.0%; and overall agreement, 100.0%
In accordance with 21 CFR 807.92(b)(3), we conclude from these data that the present device is substantially equivalent to the predicate device.