(50 days)
The QUANTA Plex™ ENA Profile 5 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB and Sc1-70 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome and scleroderma.
Not Found
This is an FDA Premarket Notification (510(k)) letter for an in vitro diagnostic device, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and comparison to human readers is not applicable in the context of an AI/ML device study.
The document describes the FDA's determination of substantial equivalence for the "QUANTA Plex™ ENA Profile 5" device to legally marketed predicate devices, allowing it to proceed to market. This process for in vitro diagnostics is different from the rigorous performance evaluation studies typically expected for AI/ML devices, which often involve comparing AI algorithms against established ground truths and human expert performance.
Here's why the specific questions are not applicable based on the provided text:
- Acceptance criteria table and device performance: The document does not provide specific performance metrics or acceptance criteria for an AI/ML algorithm. It's a regulatory clearance document, not a scientific performance study report.
- Sample size and data provenance: These details are not included as the submission is for a traditional IVD device, not an AI study.
- Number of experts, qualifications, and adjudication method: These pertain to establishing ground truth for AI model evaluation, which is not described here.
- MRMC comparative effectiveness study: This type of study is specifically designed for AI's impact on human reader performance, and is not relevant to this IVD device.
- Standalone performance: While the device has its own performance characteristics, it's not "standalone" in the AI sense (i.e., algorithm only without human-in-the-loop).
- Type of ground truth: The document indicates the device detects autoantibodies to aid in diagnosis, but does not detail how a specific "ground truth" (like pathology or outcomes data) was established for an AI algorithm's training or testing.
- Training set sample size and ground truth establishment (for training): These are AI/ML specific concepts and are not discussed in this 510(k) document.
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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 consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars extending from the top of the staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 2003
Mr. Brys C. Myers Manager, Regulatory Affairs Inova Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, CA 92131-1234
Re: K030681
Trade/Device Name: QUANTA Plex™ ENA Profile 5 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LLL Dated: March 3, 2003 Received: March 5, 2003
Dear Mr. Myers:
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 vour 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). Other general information on your responsibilities under the Act may be obtained 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 Sutman
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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Page 7 of 63
510(k) Number (if known): K030681
Device Name: QUANTA Plex™ ENA Profile 5
Indications For Use:
The QUANTA Plex™ ENA Profile 5 is a fluorescent immunosorbent assay for the semi-quantitative detection of Sm, RNP, SSA, SSB and Sc1-70 autoantibodies in human serum. The presence of these antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of systemic lupus erythematosus and related connective tissue diseases such as Sjögren's syndrome and scleroderma.
J.P. Reeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030681
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).