(133 days)
No
The summary describes a standard enzyme immunoassay for detecting antibodies and does not mention any AI or ML components.
No
This device is an in vitro diagnostic test system for detecting antibodies, not for treating any condition.
Yes
The "Intended Use / Indications for Use" explicitly states that the "test system is for in vitro diagnostic use".
No
The device description explicitly states it is an "enzyme immunoassay," which is a laboratory test involving physical reagents and procedures, 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 SS-A/Ro and SS-B/La in human serum."
This statement directly identifies the device as intended for use in diagnosing conditions by examining samples taken from the human body (in this case, serum) outside of the 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 SS-A/Ro and SS-B/La in human serum.
Product codes
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Device Description
This is an enzyme immunoassay for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La in human serum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
For direct determination of relative sensitivity and specificty, we used the Immuno Concepts RELISA® Screening Assay (K935129) as a reference method.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparison to Immuno Concepts RELISA® Screening Assay (K935129) for detection of antibodies to the SS-A(Ro) autoantigen:
- Immuno Concepts RELISA® SS-A/SS-B Positive: 62 with Immuno Concepts RELISA® Screening Assay Positive, 0 Borderline, 0 Negative.
- Immuno Concepts RELISA® SS-A/SS-B Borderline: 0 with Immuno Concepts RELISA® Screening Assay Positive, 2 Borderline, 0 Negative.
- Immuno Concepts RELISA® SS-A/SS-B Negative: 0 with Immuno Concepts RELISA® Screening Assay Positive, 0 Borderline, 96 Negative.
Comparison to Immuno Concepts RELISA® Screening Assay (K935129) for detection of antibodies to the SS-B(La) autoantigen:
- Immuno Concepts RELISA® SS-A/SS-B Positive: 32 with Immuno Concepts RELISA® Screening Assay Positive, 2 Borderline, 0 Negative.
- Immuno Concepts RELISA® SS-A/SS-B Borderline: 0 with Immuno Concepts RELISA® Screening Assay Positive, 5 Borderline, 0 Negative.
- Immuno Concepts RELISA® SS-A/SS-B Negative: 0 with Immuno Concepts RELISA® Screening Assay Positive, 0 Borderline, 121 Negative.
The two samples that gave borderline positive results with the screening assay and positive results with the SS-B(La) specific assay are considered positive samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Table 1. Detection of antibodies to the SS-A(Ro) autoantigen: relative sensitivity, 100.0%; relative specificity, 100.0%; and overall agreement, 100.0%
Table 2. Detection of antibodies to the SS-B(La) autoantigen: relative sensitivity, 100.0%; relative specificity, 100.0%; and overall agreement, 100.0%
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/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 a stylized design incorporating circles. To the right of "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® SS-A/Ro and SS-B/La Antibody Test System
- · Common Name SS-A/Ro and SS-B/La 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 SS-A/Ro and SS-B/La in human serum.
Intended Use:
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigens SS-A/Ro and SS-B/La 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 SS-A/Ro or SS-B/La 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
| Table 1. Detection of antibodies to the SS-A(Ro) autoantigen. | ||||||||
|---|---|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | -- | -- | --------------------------------------------------------------- |
| Immuno Concepts RELISA® Screening Assay | ||||
|---|---|---|---|---|
| Positive | Borderline | Negative | ||
| Positive | 62 | 0 | 0 | |
| Immuno Concepts | ||||
| RELISA® SS-A/SS-B | Borderline | 0 | 2 | 0 |
| Negative | 0 | 0 | 96 |
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 SS-B(La) autoantigen. | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| --------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Immuno Concepts RELISA® Screening Assay Positive | Borderline | Negative | ||
|---|---|---|---|---|
| Positive | 32 | 2 | 0 | |
| Immuno Concepts RELISA® SS-A/SS-B | Borderline | 0 | 5 | 0 |
| Negative | 0 | 0 | 121 |
The two samples that gave borderline positive results with the screening assay and positive results with the SS-B(La) specific assay are considered positive samples. 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.