(164 days)
The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.
Not Found
This is a 510(k) premarket notification for an in vitro diagnostic device, not an AI/ML medical device. Therefore, much of the requested information, such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types related to image analysis or AI model evaluation, are not applicable.
However, I can extract information relevant to the device's performance based on the provided document, even if it doesn't align perfectly with the AI/ML specific questions.
Here's the closest possible interpretation of your request based on the provided 510(k) summary for the TheraTest EL-ANA Profiles:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a FDA 510(k) clearance letter) does not contain a detailed table of specific acceptance criteria. FDA 510(k) clearances for in vitro diagnostics usually reference substantial equivalence to a predicate device, which implies that the new device performs at least as well as the predicate device. The performance data would typically be found in the 510(k) summary or the full submission, but is not present in this clearance letter.
Therefore, this table cannot be accurately completed from the given text. The clearance states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the device met the implicit acceptance criteria by demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the clearance letter. For an in vitro diagnostic device, the "test set" would refer to clinical samples used for validation, but the details of this are not in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly stated in the clearance letter. For in vitro diagnostics like this, "ground truth" would typically be established through clinical diagnosis of the patients from whom the samples were collected, potentially by qualified clinicians (e.g., rheumatologists, immunologists).
4. Adjudication Method for the Test Set
This information is not provided in the clearance letter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
MRMC studies are typically for image-based diagnostic devices where human readers interpret images. This device is an in vitro diagnostic test for autoantibodies, not an imaging device. Therefore, an MRMC study would not be applicable or performed for this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is an in vitro diagnostic test, not an algorithm. Its performance is inherent to the chemical and biological reactions involved in detecting the autoantibodies. Therefore, the concept of "standalone algorithm performance" is not applicable. The device is the "standalone" diagnostic tool, providing results without an intervening human interpretation step in the same way an AI model's output would need.
7. The Type of Ground Truth Used
The "ground truth" for an in vitro diagnostic test like the TheraTest EL-ANA Profiles would typically be the clinical diagnosis of the patients (e.g., diagnosis of SLE, Sjogren's syndrome, etc.) based on a combination of clinical symptoms, other laboratory tests, and expert medical opinion. The specific method for establishing this ground truth for the study supporting this 510(k) is not described in the provided document.
8. The Sample Size for the Training Set
This device is an in vitro diagnostic kit, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's performance is based on its analytical and clinical validation, not on a machine learning training process.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI/ML algorithm, this question is not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three stripes forming its body and wings. The eagle is oriented to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Theratest Laboratories, Inc. c/o Dr. Marius Teodorescu President and CEO 1111 N. Main St.
OCT 7 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K051066
Lombard, IL 60148
Trade/Device Name: Teratest EL-ANA Profiles Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LKP, LJM, MQA, LLL Dated: April 21, 2005 Received: April 27, 2005
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, 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, PKD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __ K051066
Device Name: TheraTest EL-ANA Profiles
Indications For Use:
"The EL-ANA Profiles™ is an in vitro diagnostic test for the detection and measurement of autoantibodies directed against the following autoantigens: single-stranded DNA (ssDNA), double-stranded DNA (dsDNA), Smith, RNP/Sm, SSA (Ro) "R, SSB (La) "R (30217), Gould Carding Ribosomal Protein P, Centromere™, and Chromatin (Nucleosomes). This test system is intended as an aid in diagnosis of systemic lupus erythematosus, Sjogren's syndrome, progressive systemic sclerosis (scleroderma), drug-induced lupus and polymyositis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Marie Chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K051066
§ 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).