(127 days)
The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Not Found
The provided text is a 510(k) premarket notification approval letter for a medical device called "QUANTA Lite™ SS-A 52 ELISA." This document does not contain the detailed acceptance criteria for the device's performance or the full study that proves it meets those criteria in the format requested.
The document states that the FDA has reviewed the submission and determined the device is "substantially equivalent" to legally marketed predicate devices. This means it meets the regulatory requirements for safety and effectiveness based on comparison to existing devices, but the specifics of its performance criteria and the detailed study design (like sample sizes, expert qualifications, etc.) are generally found in the full 510(k) submission which is not provided here.
Therefore, I cannot populate the table and answer the study-related questions based solely on the provided text. The document is an approval letter, not a scientific study report.
However, I can extract the following information that is present:
Device Name: QUANTA Lite™ SS-A 52 ELISA
Indications for Use: The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzyme-linked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
Regulatory Class: Class II
Product Code: OBE
Regulation Number: 21 CFR 866.5100
Regulation Name: Antinuclear antibody immunological test system
Regarding your specific questions, here's what can be inferred or stated about the absence of information:
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A table of acceptance criteria and the reported device performance: This information is not provided in the approval letter. Acceptance criteria for substantial equivalence are based on performance data (e.g., sensitivity, specificity, reproducibility, correlation with predicate) presented in the 510(k) submission, but these specific metrics and their targets are not listed here.
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Sample sizes used for the test set and the data provenance: Not mentioned in this document.
- Data provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in this document.
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Adjudication method for the test set: Not mentioned in this document.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an ELISA kit, which is an in vitro diagnostic (IVD) test, not an AI-powered imaging or diagnostic system that would typically involve human "readers" or an MRMC study comparing human performance with and without AI. So, this question is not applicable to this type of device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: As an IVD test, the "standalone" performance of the assay itself is what is evaluated. However, the details of that evaluation are not in this document.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For IVD assays, ground truth often involves clinical diagnosis confirmed by other established diagnostic criteria or reference methods. The specific type used for this device is not detailed here.
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The sample size for the training set: Not mentioned. (Note: For an ELISA, "training set" is not a standard term as it is for machine learning. The equivalent would be samples used during assay development and validation).
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How the ground truth for the training set was established: Not mentioned.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a circular seal or logo. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter of the circle. In the center of the seal is a stylized symbol that resembles three overlapping, curved lines or strokes, creating a sense of movement or flow. The overall design is simple and professional, suggesting an official or governmental affiliation.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 4 - 2007
INOVA Diagnostics, Inc. c/o Mr. Brys C. Myers Manager, Regulatory Affairs 9900 Old Grove Rd San Diego, CA 92131-1638
Re: K063565
Trade/Device Name: QUANTA Lite™ SS-A 52 ELISA Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: OBE Dated: February 15, 2007 Received: February 20, 2007
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 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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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 (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
chan for
Dr. Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): _ H 063565
Device Name: QUANTA Lite™ SS-A 52 ELISA
Indications For Use:
The QUANTA Lite™ SS-A 52 ELISA is a semiquantitative enzymelinked immunosorbent assay for the detection of IgG anti-SS-A 52 antibodies in patient sera. The presence of these antibodies, when considered in conjunction with other laboratory and clinical findings, is an aid in the diagnosis of systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR (Per 21 CFR 801.109) ma
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Over-The-Counter Use_
(Optional Format 1-2-96)
Cribe of in Vitro Diagnostic Device Evaluation and Safery
510(K) KO63565
§ 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).