(62 days)
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No
The provided 510(k) summary does not contain any mention of AI, ML, deep learning, or related concepts. The description focuses on the measurement of specific autoantibodies using a system, which is a standard laboratory technique.
No
The device is intended to measure autoantibodies for diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section states: "This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases."
Unknown
The provided text only describes the intended use of the device, which is a diagnostic aid for rheumatic diseases by measuring autoantibodies. It does not contain a device description, mention of software, hardware, or any other technical details necessary to determine if it is a software-only medical device.
Yes, based on the provided information, the EL-ANA Profiles™ device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to measure autoantibodies directed against various autoantigens." This measurement is performed on biological samples (implied by "autoantibodies").
- Aid in Diagnosis: The intended use also states that the system is "intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases." This clearly indicates its use in a diagnostic context, which is a core function of IVDs.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The EL-ANA Profiles™ fits this definition by measuring biomarkers (autoantibodies) in biological samples to aid in the diagnosis of specific diseases.
N/A
Intended Use / Indications for Use
The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P , and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.
Product codes
MQA
Device Description
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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).
0
Image /page/0/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 an eagle's head and neck, formed by three curved lines that resemble human profiles facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle's head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 0 6 2003
Marius Teodorescu, M.D., Ph.D. President and CEO TheraTest Laboratories, Inc. 1111 North Main Street Lombard, IL 60148
Re: K024151
Trade/Device Name: EL-ANA Profiles™ Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: MQA Dated: December 5, 2002 Received: December 6, 2002
Dear Dr. Teodorescu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | CHANAGE ENG LINE ALL A LEW AN . A |
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The EL-ANA Profiles™ is intended to measure autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), doublestranded DNA (dsDNA), Sm, RNP/Sm, SSA (Ro), SSB (La), Scl-70, Histones, Jo-1, Ribosomal Protein P , and Centromere. This system is intended as an aid in diagnosis of systemic lupus erythematosus and related rheumatic diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.P. Reeves for J. Bautista
Division of Clinical Laboratory Devices
KU2 4151 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)