(133 days)
No
The summary describes a standard enzyme immunoassay for antibody detection and does not mention any AI or ML components or processes.
No
This device is an in vitro diagnostic (IVD) test system for detecting antibodies, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" states, "This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Jo-1 in human serum," directly indicating its diagnostic purpose.
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 Jo-1 in human serum" explicitly states that the device is intended for in vitro diagnostic use.
- Device Description: The description "This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Jo-1 in human serum" further clarifies that the device is used to analyze a biological sample (human serum) outside of the body to diagnose or detect a condition (presence of antibodies to nuclear antigen Jo-1).
These two points are the primary indicators that a device is an IVD. The other sections, while providing details about the device and its performance, do not contradict or negate the initial declaration of its intended use as an IVD.
N/A
Intended Use / Indications for Use
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Jo-1 in human serum.
Product codes
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Device Description
This is an enzyme immunoassay for the detection of antibodies to nuclear antigen Jo-1 in human serum.
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
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.
Key Metrics
relative sensitivity, 100.0%; relative specificity, 99.3%; and overall agreement 90.4%
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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 a stylized "IC" symbol. To the right of the "IC" symbol is the word "immuno" stacked on top of the word "concepts". The logo is black and white.
APR 1 9 1996
XXXXXXXXXXXXXXXXXXXXXXXXXXXX
Date Prepared: December 4, 1995 Contact Person: Eric S. Hoy, Ph.D. Name of Device:
- · Trade Name RELISA® Jo-1 Antibody Test System
- · Common Name Jo-1 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 Jo-1 in human serum.
Intended Use:
This test system is for in vitro diagnostic use for the detection of antibodies to nuclear antigen Jo-1 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 Jo-1 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
| Immuno Concepts RELISA® Screening Assay | ||||
|---|---|---|---|---|
| Positive | Borderline | Negative | ||
| Immuno Concepts | ||||
| RELISA® Jo-1 | Positive | 21 | 1 | 0 |
| Borderline | 2 | 4 | 1 | |
| Negative | 0 | 0 | 140 |
Table 1. Detection of antibodies to the Jo-1 autoantigen.
If we assume that "borderline" results are actually positive, these data yield the following statistics: relative sensitivity, 100.0%; relative specificity, 99.3%; and overall agreement 90.4%
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.