(36 days)
No
The summary describes a standard enzyme immunoassay test system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
The device is an enzyme immunoassay test system used for the detection of antinuclear antibodies in human serum, serving as an aid in the detection of antibodies associated with systemic rheumatic disease. It is a diagnostic device, not a therapeutic one.
Yes
Explanation: The device is an "enzyme immunoassay test system for the detection of antinuclear antibodies in human serum" and is "to be used as an aid in the detection of antibodies associated with systemic rheumatic disease," which indicates its use in identifying a disease state.
No
The device description clearly states it is an "enzyme immunoassay test system" and an "enzyme immunoassay for the detection of antinuclear antibodies in human serum," which are laboratory-based tests involving physical reagents and equipment, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "test system for the detection of antinuclear antibodies in human serum." This indicates it's used to examine a sample taken from the human body (serum) in vitro (outside the body) to provide information about a physiological state (presence of antinuclear antibodies).
- Device Description: The description reinforces this by stating it's an "enzyme immunoassay for the detection of antinuclear antibodies in human serum." Immunoassays are a common type of IVD test.
- Sample Type: The device uses "human serum," which is a biological sample taken from a human.
- Purpose: The purpose is to aid in the detection of antibodies associated with systemic rheumatic disease, which is a diagnostic purpose.
All these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
Product codes
LJM
Device Description
This is an enzyme immunoassay for the detection of antinuclear antibodies 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
For direct determination of relative sensitivity and specificity, we used the Enzyme Immunoassay Antinuclear Antibody Screening Test Kit manufactured by Helix Diagnostics, West Sacramento, CA, (K954723) as a reference method. The data obtained in this comparison are shown in the following Table. These data show an overall agreement of 85.4%.
The large number of "false positive" samples seen with the Immuno Concepts test was troubling, so we tested all of these sera for antinuclear antibodies using Immuno Concepts HEp-2000® ANA-Ro Test System (K944096 & K972145). Seventy-nine of the "false positive" samples were shown to have clearly discernible ANA patterns with the indirect fluorescent antibody technique and were considered "true positives" for the detection of antinuclear antibodies. Four of the "false negative" samples were shown to be negative by the indirect fluorescent antibody technique and were considered "true negatives" for the detection of antinuclear antibodies. Thus, when the referee method is taken into account, the comparison looks like this: These data show an overall agreement of 93.5%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
KG92041
Image /page/0/Picture/2 description: The image shows the logo for Immuno Concepts. The logo consists of a stylized "IC" symbol followed by the word "immuno" in a bold, sans-serif font. Below "immuno" is the word "concepts" in a smaller, bold, sans-serif font. The logo is black and white.
- 510(k) SUMMARY *
Date Prepared: July 12, 1999 Contact Person: Eric S. Hoy, Ph.D., SI(ASCP) Name of Device:
- · Trade Name RELISA® ANA Screening Test System
- Common Name Antinuclear Antibody Enzyme Immunoassay Test System
- · Classification Name Antinuclear Antibody (21 CFR 866.5100)
Legally marketed device with which this device has been shown to be equivalent: Enzyme Immunoassay Antinuclear Antibody Screening Test Kit manufactured by Helix Diagnostics, West Sacramento, CA, K954723.
Description:
This is an enzyme immunoassay for the detection of antinuclear antibodies in human serum.
Intended Use:
This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
Summary of Technological Characteristics Compared to the Predicate Device:
Technologically, this device is similar to the predicate device with the following exceptions:
The predicate device has all 96 microwells sealed in a single pouch. a) After this pouch is opened, the wells remain stable for only 30 days. The present device has each eight well strip of microwells sealed in an individual pouch, so that unused wells remain in the pouches, and maintain at least 12 months stability.
b) The predicate device uses a cutoff control serum, the present device uses a calibrator serum in the kit.
Description of Laboratory Data That Indicate Substantial Equivalence:
For direct determination of relative sensitivity and specificity, we used the Enzyme Immunoassay Antinuclear Antibody Screening Test Kit manufactured by Helix Diagnostics, West Sacramento, CA, (K954723) as a reference method. The data obtained in this comparison are shown in the following Table.
| Helix Diagnostics Enzyme Immunoassay Antinuclear
| Antibody Screening Test | Positive | Negative | |
|---|---|---|---|
| Immuno Concepts | |||
| RELISA® Antinuclear | |||
| Antibody Test | Positive | 214 | 46 |
| Borderline | 12 | 105 | |
| Negative | 8 | 787 |
Borderline results were considered positive. These data show an overall agreement of 85.4%
1
The large number of "false positive" samples seen with the Immuno Concepts test was troubling, so we tested all of these sera for antinuclear antibodies using Immuno Concepts HEp-2000® ANA-Ro Test System (K944096 & K972145). Seventy-nine of the "false positive" samples were shown to have clearly discernible ANA patterns with the indirect fluorescent antibody technique and were considered "true positives" for the detection of antinuclear antibodies. Four of the "false negative" samples were shown to be negative by the indirect fluorescent antibody technique and were considered "true negatives" for the detection of antinuclear antibodies. Thus, when the referee method is taken into account, the comparison looks like this:
| | | Reference
Positive | Method
Negative |
|---------------------------------------------------------|----------|-----------------------|--------------------|
| Immuno Concepts
RELISA° Antinuclear
Antibody Test | Positive | 305 | 72 |
| | Negative | 4 | 791 |
These data show an overall agreement of 93.5%
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.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble waves or fabric. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 23 1999
Eric S. Hoy, Ph.D., SI (ASCP) Chief Scientific Officer Regulatory Affairs Immuno Concepts, N.A., Limited 2280 Springlake Road, Suite 106 Dallas, Texas 75234
Re: K992041
Trade Name: RELISA® ANA Screening Test System Regulatory Class: II Product Code: LJM Dated: June 15, 1999 Received: June 17, 1999
Dear Dr. Hoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K992041 510(k) number (if known):
Device Name: RELISA® ANA Screening Test System
Indications for use:
. .
This is an enzyme immunoassay test system for the detection of antinuclear antibodies in human serum. This test system is to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
イン
Peter E. Machon
vision Sign-Off) of Clinical Laboratory Devices
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________