(133 days)
No
The summary describes a standard enzyme immunoassay (ELISA) for detecting antibodies, with no mention of AI/ML terms, image processing, or data training/testing sets typically associated with AI/ML algorithms.
No.
The device is for in vitro diagnostic use for the detection of antibodies, not for therapy or treatment.
Yes
The 'Intended Use / Indications for Use' directly states that "This test system is for in vitro diagnostic use".
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: The statement "This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 in human serum" explicitly states its intended use as an in vitro diagnostic.
- Device Description: The description "This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Scl-70 in human serum" further confirms that it is a test performed outside of the body on a biological sample (human serum).
N/A
Intended Use / Indications for Use
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 in human serum.
Product codes
Not Found
Device Description
This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Scl-70 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
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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
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 Table.
Table 1. Detection of antibodies to the Scl-70 autoantigen.
Immuno Concepts RELISA® Scl-70 vs. Immuno Concepts RELISA® Screening Assay
- Positive: 37 (positive in both), 3 (positive in Scl-70, borderline in Screening), 0 (positive in Scl-70, negative in Screening)
- Borderline: 0 (borderline in Scl-70, positive in Screening), 7 (borderline in both), 0 (borderline in Scl-70, negative in Screening)
- Negative: 0 (negative in Scl-70, positive in Screening), 1 (negative in Scl-70, borderline in Screening), 129 (negative in both)
Key Metrics
relative sensitivity, 97.9%; relative specificity, 100%; and overall agreement, 99.4%
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, and the words "immuno concepts" in a smaller font size. The logo is black and white.
APR 1 9 1996
Date Prepared: December 4, 1995 Contact Person: Eric S. Hoy, Ph.D. Name of Device:
- · Trade Name RELISA® Scl-70 Antibody Test System
- Common Name Sc1-70 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 antigen Scl-70 in human serum.
Intended Use:
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Scl-70 in human serum.
Summary of Technological Characteristics Compared to the Predicate Device:
This device is identical to the predicate device with the following exceptions :
a) The predicate device has six different autoantigens coated on individual microwells; the present device has only Scl-70 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 Table.
1
K 955402
| | | Positive | Immuno Concepts RELISA® Screening Assay
Borderline | Negative |
|-----------------------------------|------------|----------|-------------------------------------------------------|----------|
| Immuno Concepts
RELISA® Scl-70 | Positive | 37 | 3 | 0 |
| | Borderline | 0 | 7 | 0 |
| | Negative | 0 | 1 | 129 |
Table 1. Detection of antibodies to the Scl-70 autoantigen.
If we assume that "borderline" results are actually positive, these data yield the following statistics: relative sensitivity, 97.9%; relative specificity, 100%; and overall agreement, 99.4%
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.